SPIRIT PRIME Clinical Trial

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00916370
• Collaborator: (none)
• Enrollment: 525
• Locations: 62
• Arms: 2
• Duration (Months): 56
• Patients Per Site: 8.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

To evaluate the safety and effectiveness of the XIENCE PRIME and XIENCE PRIME Long Lesion (LL) Everolimus Eluting Coronary Stent System (EECSS) in improving coronary luminal diameter in subjects with symptomatic heart disease due to a maximum of two de novo native coronary artery lesions, each in a different epicardial vessel.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis	Device: Core size Xience Prime; Device: Xience Prime Long Lesion (LL)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 525 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: SPIRIT PRIME Clinical Trial.
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Core size registry (CSR) Core size indicates the range of diameters of the stents used.	Device: Core size Xience Prime; Core size includes a range of stent sizes.
Experimental: Long lesion registry (LLR) Use of long lesion stents.	Device: Xience Prime Long Lesion (LL); Long lesion stent sizes include a range of sizes.

Outcome Measures

Primary Outcome Measures

1. Target Lesion Failure (TLF) [1 year]

   The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.

2. Target Lesion Failure (TLF) [2 years]

   The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.

3. Target Lesion Failure (TLF) [3 years]

   The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.

Secondary Outcome Measures

1. Procedure Time [From insertion to withdrawal of guide catheter]

   Procedure time is defined as time between insertion and withdrawal of guide catheter.

2. Device Success (Lesion Basis) [From the start of index procedure to end of index procedure]

   Device success is defined as achievement of a final in-stent residual diameter stenosis of < 50% (by QCA).

3. Procedural Success (Subject Basis) [From the start of index procedure to end of index procedure]

   Procedure success is defined as achievement of a final in-stent diameter stenosis of < 50% (by QCA). Per Protocol.

4. All Death (Cardiac, Vascular, Non-cardiovascular) [In-hospital is less than or equal to 7 days post index procedure]

5. All Death (Cardiac, Vascular, Non-cardiovascular) [30 days]

6. All Death (Cardiac, Vascular, Non-cardiovascular) [180 days]

7. All Death (Cardiac, Vascular, Non-cardiovascular) [1 year]

8. All Death (Cardiac, Vascular, Non-cardiovascular) [2 years]

9. All Death (Cardiac, Vascular, Non-cardiovascular) [3 years]

10. Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) [In-hospital is defined as hospitalization less than or equal to 7 days post index procedure.]

    Per Protocol

11. Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) [30 days]

    Per Protocol

12. Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) [180 days]

    Per Protocol

13. Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) [1 year]

    Per Protocol

14. Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) [2 years]

    Per Protocol

15. Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) [3 years]

    Per Protocol

16. Non-target Vessel MI (Q-wave, Non Q-wave) [In-hospital is defined as hospitalization less than or equal to 7 days post index procedure]

    Per Protocol

17. Non-target Vessel MI (Q-wave, Non Q-wave) [30 days]

    Per Protocol

18. Non-target Vessel MI (Q-wave, Non Q-wave) [180 days]

    Per Protocol

19. Non-target Vessel MI (Q-wave, Non Q-wave) [1 year]

    Per Protocol

20. Non-target Vessel MI (Q-wave, Non Q-wave) [2 years]

    Per Protocol

21. Non-target Vessel MI (Q-wave, Non Q-wave) [3 years]

    Per Protocol

22. Clinically Indicated-Target Lesion Revascularization [In-hospital is defined as hospitalization less than or equal to 7 days post index procedure]

23. Clinically Indicated-Target Lesion Revascularization [30 days]

24. Clinically Indicated-Target Lesion Revascularization [180 days]

25. Clinically Indicated-Target Lesion Revascularization [1 year]

26. Clinically Indicated-Target Lesion Revascularization [2 years]

27. Clinically Indicated-Target Lesion Revascularization [3 years]

28. Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) [In-hospital is defined as hospitalization less than or equal to 7 days post index procedure]

29. Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) [30 days]

30. Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) [180 days]

31. Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) [1 year]

32. Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) [2 years]

33. Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) [3 years]

34. All TLR (CI and Non-CI) [In-hospital is defined as hospitalization less than or equal to 7 days post index procedure]

35. All TLR (CI and Non-CI) [30 days]

36. All TLR (CI and Non-CI) [180 days]

37. All TLR (CI and Non-CI) [1 year]

38. All TLR (CI and Non-CI) [2 years]

39. All TLR (CI and Non-CI) [3 years]

40. All TVR (CI and Non-CI) [In-hospital is defined as hospitalization less than or equal to 7 days post index procedure]

41. All TVR (CI and Non-CI) [30 days]

42. All TVR (CI and Non-CI) [180 days]

43. All TVR (CI and Non-CI) [1 year]

44. All TVR (CI and Non-CI) [2 years]

45. All TVR (CI and Non-CI) [3 years]

46. All Coronary Revascularization (TVR and Non-TVR) [In-hospital is defined as hospitalization less than or equal to 7 days post index procedure]

47. All Coronary Revascularization (TVR and Non-TVR) [30 days]

48. All Coronary Revascularization (TVR and Non-TVR) [180 days]

49. All Coronary Revascularization (TVR and Non-TVR) [1 year]

50. All Coronary Revascularization (TVR and Non-TVR) [2 years]

51. All Coronary Revascularization (TVR and Non-TVR) [3 years]

52. Cardiac Death/All MI [In-hospital is defined as hospitalization less than or equal to 7 days post index procedure]

53. Cardiac Death/ All MI [30 days]

    Per Protocol

54. Cardiac Death/All MI [180 days]

    Per Protocol

55. Cardiac Death/All MI [1 year]

    Per Protocol

56. Cardiac Death/All MI [2 years]

    Per Protocol

57. Cardiac Death/All MI [3 years]

    Per Protocol

58. Cardiac Death/ All MI/CI-TLR [in-hospital]

59. Cardiac Death/ All MI/CI-TLR [30 days]

    Per Protocol

60. Cardiac Death/ All MI/CI-TLR [180 days]

    Per Protocol

61. Cardiac Death/ All MI/CI-TLR [1 year]

    Per Protocol

62. Cardiac Death/ All MI/CI-TLR [2 years]

    Per Protocol

63. Cardiac Death/ All MI/CI-TLR [3 years]

    Per Protocol

64. All Death/All MI/All Coronary Revascularization [In-hospital is defined as hospitalization less than or equal to 7 days post index procedure]

    Per Protocol

65. All Death/All MI/All Coronary Revascularization [30 days]

    Per Protocol

66. All Death/All MI/All Coronary Revascularization [180 days]

    Per Protocol

67. All Death/All MI/All Coronary Revascularization [1 year]

    Per Protocol

68. All Death/All MI/All Coronary Revascularization [2 years]

    Per Protocol

69. All Death/All MI/All Coronary Revascularization [3 years]

    Per Protocol

70. Stent Thrombosis [Acute (≤1 day)]

    Per protocol and per Academic Research Consortium (ARC, definite/probable)

71. Stent Thrombosis [Subacute (>1 - 30 days)]

    Per protocol and per ARC

72. Stent Thrombosis [Acute/Subacute (0 - 30 days)]

    Per protocol and per ARC

73. Stent Thrombosis [Late (31 - 393 days)]

    Per protocol and per ARC

74. Stent Thrombosis [Late (31 - 758 days)]

    Per protocol

75. Stent Thrombosis [Very Late (394 - 758 days)]

    Per ARC, definite and probable

76. Stent Thrombosis [Late (31 - 1123 days)]

    Per protocol

77. Stent Thrombosis [Very Late (394 - 1123 days)]

    Per ARC, definite and probable

78. Stent Thrombosis [Overall (0-393 days)]

    Per protocol and per ARC

79. Stent Thrombosis [Overall (0-758 days)]

    Per protocol

80. Stent Thrombosis [Overall (0-758 days)]

    Per ARC, definite and probable

81. Stent Thrombosis [Overall (0 - 1123 days)]

    Per protocol

82. Stent Thrombosis [Overall (0 - 1123 days)]

    Per ARC, definite and probable

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject must be at least 18 years of age.

2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements.

3. Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia).

4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.

5. Subject must agree to undergo all protocol-required follow-up procedures.

6. Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.

Angiographic Inclusion Criteria

1. One or two de novo target lesions each in a different epicardial vessel.

2. If there are two target lesions, both lesions must satisfy the angiographic eligibility criteria for that registry.

o Multiple focal de novo lesions in a target vessel that can be covered by a single stent are allowed.

1. The target lesion(s) must be located in a major artery or branch with a visually estimated diameter stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1.

2. Target lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of:

• ≥ 2.25 mm and ≤ 4.25 mm for treatment by the core size XIENCE PRIME EECS

• ≥ 2.5 mm and ≤ 4.25 mm for treatment by the XIENCE PRIME LL EECS

1. Target lesion(s) must be located in a native coronary artery with length by visual estimation of:

• ≤ 22 mm for treatment by the core size XIENCE PRIME EECS

• 22 mm and ≤ 32 mm for treatment by the XIENCE PRIME LL EECS

Exclusion Criteria:

1. Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK and CK-MB have not returned to within normal limits at the time of procedure.

2. The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.

3. Subject has current unstable cardiac arrhythmias associated with hemodynamic instability.

4. Subject has a known left ventricular ejection fraction (LVEF) < 30% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).

5. Subject has received coronary brachytherapy in any epicardial vessel (target or non target).

6. Subject has received any organ transplant or is on a waiting list for any organ transplant.

7. Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure.

8. Subject is receiving or scheduled to receive planned radiotherapy to the chest/mediastinum.

9. Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.).

10. Subject is receiving chronic anticoagulation therapy (e.g., heparin, coumadin).

11. Subject will require Low Molecular Weight Heparin (LMWH) post-procedure.

12. Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.

13. Elective surgery is planned within 12 months after the procedure that will require discontinuing either aspirin or clopidogrel.

14. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a white blood cell (WBC) of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis).

15. Subject has known renal insufficiency (examples being but not limited to estimated glomerular filtration rate (eGFR) < 60 ml/kg/m2, serum creatinine level ≥ 2.5 mg/dL, or on dialysis).

16. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.

17. Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months.

18. Subject has had a significant gastro-intestinal or significant urinary bleed within the past six months.

19. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.

20. Subject has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).

21. Subject is currently participating in another clinical study that has not yet completed its primary endpoint.

22. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.

Angiographic Exclusion Criteria All angiographic exclusion criteria are based on visual estimation.

1. Target lesion located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion) arterial or saphenous vein graft.

2. Target lesion involving a bifurcation with a side branch ≥ 2 mm in diameter and/or ostial lesion > 40% stenosed or side branch requiring protection guide wire, or side branch requiring dilatation.

3. Target lesion with total occlusion (TIMI flow 0), prior to crossing with the wire.

4. Another lesion requiring revascularization is located in the same epicardial vessel of the target lesion.

5. Restenotic target lesion.

6. Aorto-ostial target lesion (within 3 mm of the aorta junction).

7. Target lesion is in a left main location.

8. Target lesion located within 2 mm of the origin of the LAD or LCX.

9. Extreme angulation (≥ 90 °) or excessive tortuosity (≥ two 45° angles) proximal to or within the lesion.

10. Heavy calcification proximal to or within the target lesion.

11. Target vessel contains thrombus as indicated in the angiographic images.

12. Target lesion has a high probability that a procedure other than pre-dilatation and stenting will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon).

13. Target vessel is previously treated with any type of PCI (e.g. balloon angioplasty, stent, cutting balloon, atherectomy) < 9 months prior to index procedure.

14. Non-target vessel is previously treated with any type of PCI < 90 days prior to the index procedure.

15. Additional clinically significant lesion(s) (e.g. %DS ≥ 50%) in a target vessel or side branch for which PCI may be required < 90 days after the index procedure.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thomas Hospital	Fairhope	Alabama	United States	36532
2	Scottsdale Healthcare	Scottsdale	Arizona	United States	85260
3	Mercy General Hospital	Sacramento	California	United States	95819
4	Washington Hospital Center	Washington	District of Columbia	United States	20010
5	Morton Plant Hospital	Clearwater	Florida	United States	33765
6	St. Vincents Medical Center	Jacksonville	Florida	United States	32204
7	Orlando Regional Medical Center	Orlando	Florida	United States	32806
8	Sacred Heart Hospital of Pensicola	Pensacola	Florida	United States	32504-8721
9	St. John's Hospital	Springfield	Illinois	United States	62701
10	St. Vincent Heart Center of Indiana	Indianapolis	Indiana	United States	46260
11	Iowa Heart Center P.C.	West Des Moines	Iowa	United States	50314
12	University of Kansas Hospital	Kansas City	Kansas	United States	66160
13	Willis Knighton Health System, Pierremont	Shreveport	Louisiana	United States	71105
14	Union Memorial Hospital	Baltimore	Maryland	United States	21218
15	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
16	Peninsula Regional Medical Center	Salisbury	Maryland	United States	21801
17	Washington Adventist Hospital	Takoma Park	Maryland	United States	20912
18	Cape Cod Hospital	Hyannis	Massachusetts	United States	02601
19	Bay Regional Medical Center	Bay City	Michigan	United States	48706
20	Borgess Medical Center	Kalamazoo	Michigan	United States	49048
21	Northern Michigan Hospital	Petoskey	Michigan	United States	49770
22	Beaumont Hospital	Royal Oak	Michigan	United States	48073
23	Abbott Northwestern Hospital	Minneapolis	Minnesota	United States	55407
24	St. Luke's Hospital	Kansas City	Missouri	United States	64111
25	Barnes Jewish Hospital	St. Louis	Missouri	United States	63110
26	St. Patrick Hospital	Missoula	Montana	United States	59802
27	Cooper Health System	Camden	New Jersey	United States	08103
28	The Valley Hospital	Ridgewood	New Jersey	United States	07450
29	Gotham Cardiology	New York	New York	United States	10011
30	Mount Sinai Medical Center	NY	New York	United States	10029
31	Presbyterian Hospital - Charlotte	Charlotte	North Carolina	United States	28233
32	Forsyth Medical Center	Winston-Salem	North Carolina	United States	27103
33	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina	United States	27157
34	The Christ Hospital	Cincinnati	Ohio	United States	45219
35	University Hospitals of Cleveland	Cleveland	Ohio	United States	44106
36	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
37	EMH Regional Medical Center	Elyria	Ohio	United States	44035
38	St. Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
39	Hillcrest Medical Center	Tulsa	Oklahoma	United States	74104
40	Providence St. Vincent Medical Center	Portland	Oregon	United States	97225
41	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
42	Pinnacle Health @ Harrisburg Hospital	Harrisburg	Pennsylvania	United States	17043
43	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
44	AnMed Health	Anderson	South Carolina	United States	29621
45	Sanford USD Medical Center	Sioux Falls	South Dakota	United States	57104
46	Wellmont Holston Valley Medical Center	Kingsport	Tennessee	United States	37660
47	Northwest Texas Healthcare System	Amarillo	Texas	United States	79106
48	Heart Hospital of Austin	Austin	Texas	United States	78756
49	St. Luke's Episcopal Hospital	Houston	Texas	United States	77030
50	The Methodist Hospital	Pearland	Texas	United States	77581
51	Fletcher Allen Health Care	Burlington	Vermont	United States	05401
52	Sentara Norfolk General Hospital	Norfolk	Virginia	United States	23507
53	Overlake Hospital Medical Center	Bellevue	Washington	United States	98004
54	St. Joseph Hospital	Bellingham	Washington	United States	98225
55	Heart Clinics Northwest/ Sacred Heart Medical Center	Spokane	Washington	United States	99204
56	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin	United States	53215
57	Wesley Hospital	Auchenflower	Queensland	Australia
58	The Prince Charles Hospital	Chermside	Queensland	Australia	4061
59	Monash Heart	Clayton	Victoria	Australia	3168
60	St. Vincent's Hospital	Melbourne	Victoria	Australia	3065
61	Epworth Hospital	Richmond	Victoria	Australia	3121
62	Royal Perth Hospital	Perth	Western Australia	Australia

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Marco Costa, MD, PhD, University Hospitals Cleveland Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00916370
• Other Study ID Numbers: 06-373
• First Posted: Jun 9, 2009
• Last Update Posted: Jun 8, 2015
• Last Verified: May 1, 2015

• Keywords provided by Abbott Medical Devices: drug eluting stents; stents; Angioplasty; myocardial ischemia; coronary artery stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis; Long lesion
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Coronary Stenosis; Coronary Restenosis; Ischemia

Study Results

Participant Flow

Recruitment Details	Subjects enrolled into this trial will be male and female subjects from the general interventional cardiology population. The study commenced on June 5, 2009 with the first subject enrolled on June 15, 2009. The last subject in the CSR was enrolled February 12, 2010, and the last subject enrolled in LLR was on April 6, 2010.
Pre-assignment Detail	Intention-to-treat (ITT) set includes 525 subjects: 415 in core size registry (CSR) arm and 110 in long lesion registry (LLR) arm. Full analysis set (FAS) (n=505, 401 in CSR arm and 104 in LLR arm) includes subjects who have received at least 1 of the following: the core size XIENCE PRIME or XIENCE PRIME LL stent system, including bailout.

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Period Title: Overall Study
STARTED	401	104
COMPLETED	396	102
NOT COMPLETED	5	2

Baseline Characteristics

Arm/Group Title	Core Size Registry	Long Lesion Registry	Total
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.	Total of all reporting groups
Overall Participants	401	104	505
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	234 58.4%	56 53.8%	290 57.4%
>=65 years	167 41.6%	48 46.2%	215 42.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.70 (10.23)	63.46 (9.44)	62.86 (10.07)
Sex: Female, Male (Count of Participants)
Female	119 29.7%	39 37.5%	158 31.3%
Male	282 70.3%	65 62.5%	347 68.7%
Region of Enrollment (participants) [Number]
United States	376 93.8%	96 92.3%	472 93.5%
Australia	25 6.2%	8 7.7%	33 6.5%

Outcome Measures

1. Primary Outcome

Title	Target Lesion Failure (TLF)
Description	The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Measure Participants	399	104
Number [percentage of participants]	4.5 1.1%	7.7 7.4%

2. Secondary Outcome

Title	Procedure Time
Description	Procedure time is defined as time between insertion and withdrawal of guide catheter.
Time Frame	From insertion to withdrawal of guide catheter

Outcome Measure Data

Analysis Population Description

The analysis was done to include only subjects with post index procedure cardiac enzyme data in window (between 8 hours post index procedure and hospital discharge). Therefore, the final analysis contained 403 ITT CSR subjects and 106 ITT LLR subjects.

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Measure Participants	403	106
Mean (Standard Deviation) [Minutes]	32.6 (21.1)	46.9 (30.9)

3. Secondary Outcome

Title	Device Success (Lesion Basis)
Description	Device success is defined as achievement of a final in-stent residual diameter stenosis of < 50% (by QCA).
Time Frame	From the start of index procedure to end of index procedure

Outcome Measure Data

Analysis Population Description

The analysis was done to include only subjects with post index procedure cardiac enzyme data in window (between 8 hours post index procedure and hospital discharge). Therefore, the final analysis contained 403 ITT CSR subjects and 106 ITT LLR subjects.

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Measure Participants	403	106
Measure Lesions	449	125
Number [percentage of lesions]	98.2	97.6

4. Secondary Outcome

Title	Procedural Success (Subject Basis)
Description	Procedure success is defined as achievement of a final in-stent diameter stenosis of < 50% (by QCA). Per Protocol.
Time Frame	From the start of index procedure to end of index procedure

Outcome Measure Data

Analysis Population Description

The analysis was done to include only subjects with post index procedure cardiac enzyme data in window (between 8 hours post index procedure and hospital discharge). Out of these subjects, 2 in the CSR and 1 in the LLR did not have QCA data and therefore were excluded. So, the final analysis contained 401 ITT CSR subjects and 105 ITT LLR subjects.

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Measure Participants	401	105
Number [percentage of participants]	97.8 24.4%	94.3 90.7%

5. Secondary Outcome

Title	All Death (Cardiac, Vascular, Non-cardiovascular)
Time Frame	In-hospital is less than or equal to 7 days post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Measure Participants	401	104
Number [percentage of participants]	0.0 0%	0.0 0%

6. Secondary Outcome

Title	All Death (Cardiac, Vascular, Non-cardiovascular)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Measure Participants	401	104
Number [percentage of participants]	0.0 0%	0.0 0%

7. Secondary Outcome

Title	All Death (Cardiac, Vascular, Non-cardiovascular)
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Measure Participants	399	104
Number [percentage of participants]	0.5 0.1%	0.0 0%

8. Secondary Outcome

Title	All Death (Cardiac, Vascular, Non-cardiovascular)
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	399	104
Number [percentage of participants]	0.8 0.2%	1.0 1%

9. Secondary Outcome

Title	All Death (Cardiac, Vascular, Non-cardiovascular)
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	392	104
Number [percentage of participants]	2.0 0.5%	2.9 2.8%

10. Secondary Outcome

Title	All Death (Cardiac, Vascular, Non-cardiovascular)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	390	104
Number [percentage of participants]	3.1 0.8%	2.9 2.8%

11. Secondary Outcome

Title	Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Description	Per Protocol
Time Frame	In-hospital is defined as hospitalization less than or equal to 7 days post index procedure.

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Measure Participants	401	104
Number [percentage of participants]	1.7 0.4%	4.8 4.6%

12. Secondary Outcome

Title	Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Description	Per Protocol
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Measure Participants	401	104
Number [percentage of participants]	1.7 0.4%	4.8 4.6%

13. Secondary Outcome

Title	Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Description	Per Protocol
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	399	104
Number [percentage of participants]	1.8 0.4%	4.8 4.6%

14. Secondary Outcome

Title	Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Description	Per Protocol
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	399	104
Number [percentage of participants]	1.8 0.4%	4.8 4.6%

15. Secondary Outcome

Title	Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Description	Per Protocol
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	392	104
Number [percentage of participants]	1.8 0.4%	4.8 4.6%

16. Secondary Outcome

Title	Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Description	Per Protocol
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	390	104
Number [percentage of participants]	2.6 0.6%	4.8 4.6%

17. Secondary Outcome

Title	Non-target Vessel MI (Q-wave, Non Q-wave)
Description	Per Protocol
Time Frame	In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Measure Participants	401	104
Number [percentage of participants]	0.0 0%	0.0 0%

18. Secondary Outcome

Title	Non-target Vessel MI (Q-wave, Non Q-wave)
Description	Per Protocol
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Measure Participants	401	104
Number [percentage of participants]	0.0 0%	0.0 0%

19. Secondary Outcome

Title	Non-target Vessel MI (Q-wave, Non Q-wave)
Description	Per Protocol
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	399	104
Number [percentage of participants]	0.0 0%	0.0 0%

20. Secondary Outcome

Title	Non-target Vessel MI (Q-wave, Non Q-wave)
Description	Per Protocol
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Measure Participants	399	104
Number [percentage of participants]	0.0 0%	0.0 0%

21. Secondary Outcome

Title	Non-target Vessel MI (Q-wave, Non Q-wave)
Description	Per Protocol
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	392	104
Number [percentage of participants]	0.3 0.1%	1.9 1.8%

22. Secondary Outcome

Title	Non-target Vessel MI (Q-wave, Non Q-wave)
Description	Per Protocol
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	390	104
Number [percentage of participants]	0.8 0.2%	1.9 1.8%

23. Secondary Outcome

Title	Clinically Indicated-Target Lesion Revascularization
Time Frame	In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Measure Participants	401	104
Number [percentage of participants]	0.2 0%	1.0 1%

24. Secondary Outcome

Title	Clinically Indicated-Target Lesion Revascularization
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	401	104
Number [percentage of participants]	0.5 0.1%	1.0 1%

25. Secondary Outcome

Title	Clinically Indicated-Target Lesion Revascularization
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Measure Participants	399	104
Number [percentage of participants]	1.8 0.4%	1.9 1.8%

26. Secondary Outcome

Title	Clinically Indicated-Target Lesion Revascularization
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	399	104
Number [percentage of participants]	2.5 0.6%	2.9 2.8%

27. Secondary Outcome

Title	Clinically Indicated-Target Lesion Revascularization
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	392	104
Number [percentage of participants]	4.1 1%	4.8 4.6%

28. Secondary Outcome

Title	Clinically Indicated-Target Lesion Revascularization
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	390	104
Number [percentage of participants]	5.4 1.3%	4.8 4.6%

29. Secondary Outcome

Title	Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Time Frame	In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Measure Participants	401	104
Number [percentage of participants]	0.5 0.1%	1.0 1%

30. Secondary Outcome

Title	Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	401	104
Number [percentage of participants]	1.2 0.3%	1.9 1.8%

31. Secondary Outcome

Title	Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	399	104
Number [percentage of participants]	3.3 0.8%	3.8 3.7%

32. Secondary Outcome

Title	Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	399	104
Number [percentage of participants]	4.5 1.1%	4.8 4.6%

33. Secondary Outcome

Title	Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	392	104
Number [percentage of participants]	6.9 1.7%	7.7 7.4%

34. Secondary Outcome

Title	Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	390	104
Number [percentage of participants]	9.5 2.4%	7.7 7.4%

35. Secondary Outcome

Title	All TLR (CI and Non-CI)
Time Frame	In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Measure Participants	401	104
Number [percentage of participants]	0.2 0%	1.0 1%

36. Secondary Outcome

Title	All TLR (CI and Non-CI)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	401	104
Number [percentage of participants]	0.5 0.1%	1.0 1%

37. Secondary Outcome

Title	All TLR (CI and Non-CI)
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	399	104
Number [percentage of participants]	2.0 0.5%	1.9 1.8%

38. Secondary Outcome

Title	All TLR (CI and Non-CI)
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	399	104
Number [percentage of participants]	2.8 0.7%	2.9 2.8%

39. Secondary Outcome

Title	All TLR (CI and Non-CI)
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	392	104
Number [percentage of participants]	4.3 1.1%	4.8 4.6%

40. Secondary Outcome

Title	All TLR (CI and Non-CI)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	390	104
Number [percentage of participants]	5.6 1.4%	4.8 4.6%

41. Secondary Outcome

Title	All TVR (CI and Non-CI)
Time Frame	In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Measure Participants	401	104
Number [percentage of participants]	0.5 0.1%	1.0 1%

42. Secondary Outcome

Title	All TVR (CI and Non-CI)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	401	104
Number [percentage of participants]	1.2 0.3%	1.9 1.8%

43. Secondary Outcome

Title	All TVR (CI and Non-CI)
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	399	104
Number [percentage of participants]	3.5 0.9%	3.8 3.7%

44. Secondary Outcome

Title	All TVR (CI and Non-CI)
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	399	104
Number [percentage of participants]	4.8 1.2%	4.8 4.6%

45. Secondary Outcome

Title	All TVR (CI and Non-CI)
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	392	104
Number [percentage of participants]	7.1 1.8%	7.7 7.4%

46. Secondary Outcome

Title	All TVR (CI and Non-CI)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	390	104
Number [percentage of participants]	10 2.5%	7.7 7.4%

47. Secondary Outcome

Title	All Coronary Revascularization (TVR and Non-TVR)
Time Frame	In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Measure Participants	401	104
Number [percentage of participants]	0.5 0.1%	1.0 1%

48. Secondary Outcome

Title	All Coronary Revascularization (TVR and Non-TVR)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	401	104
Number [percentage of participants]	1.5 0.4%	3.8 3.7%

49. Secondary Outcome

Title	All Coronary Revascularization (TVR and Non-TVR)
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	399	104
Number [percentage of participants]	4.8 1.2%	6.7 6.4%

50. Secondary Outcome

Title	All Coronary Revascularization (TVR and Non-TVR)
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	399	104
Number [percentage of participants]	6.8 1.7%	8.7 8.4%

51. Secondary Outcome

Title	All Coronary Revascularization (TVR and Non-TVR)
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	392	104
Number [percentage of participants]	10.5 2.6%	13.5 13%

52. Secondary Outcome

Title	All Coronary Revascularization (TVR and Non-TVR)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	390	104
Number [percentage of participants]	14.9 3.7%	14.4 13.8%

53. Secondary Outcome

Title	Cardiac Death/All MI
Time Frame	In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Measure Participants	401	104
Number [percentage of participants]	1.7 0.4%	4.8 4.6%

54. Secondary Outcome

Title	Cardiac Death/ All MI
Description	Per Protocol
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Measure Participants	401	104
Number [percentage of participants]	1.7 0.4%	4.8 4.6%

55. Secondary Outcome

Title	Cardiac Death/All MI
Description	Per Protocol
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Measure Participants	399	104
Number [percentage of participants]	2.0 0.5%	4.8 4.6%

56. Secondary Outcome

Title	Cardiac Death/All MI
Description	Per Protocol
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Measure Participants	399	104
Number [percentage of participants]	2.0 0.5%	4.8 4.6%

57. Secondary Outcome

Title	Cardiac Death/All MI
Description	Per Protocol
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	392	104
Number [percentage of participants]	2.6 0.6%	5.8 5.6%

58. Secondary Outcome

Title	Cardiac Death/All MI
Description	Per Protocol
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	390	104
Number [percentage of participants]	3.8 0.9%	5.8 5.6%

59. Secondary Outcome

Title	Cardiac Death/ All MI/CI-TLR
Time Frame	in-hospital

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	401	104
Number [percentage of participants]	2.0 0.5%	5.8 5.6%

60. Secondary Outcome

Title	Cardiac Death/ All MI/CI-TLR
Description	Per Protocol
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	401	104
Number [percentage of participants]	2.2 0.5%	5.8 5.6%

61. Secondary Outcome

Title	Cardiac Death/ All MI/CI-TLR
Description	Per Protocol
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	399	104
Number [percentage of participants]	3.8 0.9%	6.7 6.4%

62. Secondary Outcome

Title	Cardiac Death/ All MI/CI-TLR
Description	Per Protocol
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	399	104
Number [percentage of participants]	4.5 1.1%	7.7 7.4%

63. Secondary Outcome

Title	Cardiac Death/ All MI/CI-TLR
Description	Per Protocol
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	392	104
Number [percentage of participants]	6.6 1.6%	10.6 10.2%

64. Secondary Outcome

Title	Cardiac Death/ All MI/CI-TLR
Description	Per Protocol
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	390	104
Number [percentage of participants]	9.0 2.2%	10.6 10.2%

65. Secondary Outcome

Title	All Death/All MI/All Coronary Revascularization
Description	Per Protocol
Time Frame	In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Measure Participants	401	104
Number [percentage of participants]	2.2 0.5%	5.8 5.6%

66. Secondary Outcome

Title	All Death/All MI/All Coronary Revascularization
Description	Per Protocol
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	401	104
Number [percentage of participants]	3.2 0.8%	8.7 8.4%

67. Secondary Outcome

Title	All Death/All MI/All Coronary Revascularization
Description	Per Protocol
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	399	104
Number [percentage of participants]	7.0 1.7%	11.5 11.1%

68. Secondary Outcome

Title	All Death/All MI/All Coronary Revascularization
Description	Per Protocol
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	399	104
Number [percentage of participants]	9.0 2.2%	14.4 13.8%

69. Secondary Outcome

Title	All Death/All MI/All Coronary Revascularization
Description	Per Protocol
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	392	104
Number [percentage of participants]	13.8 3.4%	20.2 19.4%

70. Secondary Outcome

Title	All Death/All MI/All Coronary Revascularization
Description	Per Protocol
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	390	104
Number [percentage of participants]	19 4.7%	20.2 19.4%

71. Secondary Outcome

Title	Stent Thrombosis
Description	Per protocol and per Academic Research Consortium (ARC, definite/probable)
Time Frame	Acute (≤1 day)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	401	104
Per ARC	0.5 0.1%	0.0 0%
Per Protocol	0.5 0.1%	0.0 0%

72. Secondary Outcome

Title	Stent Thrombosis
Description	Per protocol and per ARC
Time Frame	Subacute (>1 - 30 days)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	401	104
Per ARC	0.0 0%	0.0 0%
Per Protocol	0.0 0%	0.0 0%

73. Secondary Outcome

Title	Stent Thrombosis
Description	Per protocol and per ARC
Time Frame	Acute/Subacute (0 - 30 days)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	401	104
Per ARC	0.5 0.1%	0.0 0%
Per Protocol	0.5 0.1%	0.0 0%

74. Secondary Outcome

Title	Stent Thrombosis
Description	Per protocol and per ARC
Time Frame	Late (31 - 393 days)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	399	104
Per ARC	0.0 0%	0.0 0%
Per Protocol	0.0 0%	0.0 0%

75. Secondary Outcome

Title	Stent Thrombosis
Description	Per protocol
Time Frame	Late (31 - 758 days)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	385	100
Number [percentage of participants]	0.3 0.1%	0.0 0%

76. Secondary Outcome

Title	Stent Thrombosis
Description	Per ARC, definite and probable
Time Frame	Very Late (394 - 758 days)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	385	100
Number [percentage of participants]	0.0 0%	0.0 0%

77. Secondary Outcome

Title	Stent Thrombosis
Description	Per protocol
Time Frame	Late (31 - 1123 days)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	378	99
Number [percentage of participants]	0.5 0.1%	0.0 0%

78. Secondary Outcome

Title	Stent Thrombosis
Description	Per ARC, definite and probable
Time Frame	Very Late (394 - 1123 days)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	379	99
Number [percentage of participants]	0.3 0.1%	0 0%

79. Primary Outcome

Title	Target Lesion Failure (TLF)
Description	The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Measure Participants	392	104
Number [percentage of participants]	6.4 1.6%	9.6 9.2%

80. Primary Outcome

Title	Target Lesion Failure (TLF)
Description	The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	Use of long lesion stents.
Measure Participants	390	104
Number [percentage of participants]	8.5 2.1%	9.6 9.2%

81. Secondary Outcome

Title	Stent Thrombosis
Description	Per protocol and per ARC
Time Frame	Overall (0-393 days)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	399	104
Per ARC	0.5 0.1%	0.0 0%
Per Protocol	0.5 0.1%	0.0 0%

82. Secondary Outcome

Title	Stent Thrombosis
Description	Per protocol
Time Frame	Overall (0-758 days)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	385	100
Number [percentage of participants]	0.8 0.2%	0.0 0%

83. Secondary Outcome

Title	Stent Thrombosis
Description	Per ARC, definite and probable
Time Frame	Overall (0-758 days)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	386	100
Number [percentage of participants]	0.5 0.1%	0 0%

84. Secondary Outcome

Title	Stent Thrombosis
Description	Per protocol
Time Frame	Overall (0 - 1123 days)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	378	99
Number [percentage of participants]	1.1 0.3%	0.0 0%

85. Secondary Outcome

Title	Stent Thrombosis
Description	Per ARC, definite and probable
Time Frame	Overall (0 - 1123 days)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Arm/Group Title	Core Size Registry	Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.	use of long lesion stents.
Measure Participants	380	99
Number [percentage of participants]	0.8 0.2%	0 0%

Adverse Events

Time Frame	3 years
Adverse Event Reporting Description	These are site-reported, un-adjudicated adverse events regardless of relationship to the device in intention-to-treat population. The number of participants at risk excludes subjects who were early terminated up to 1123 days and had no events through the given timepoint
Arm/Group Title	Core Size Registry		Long Lesion Registry
Arm/Group Description	Core size indicates the range of diameters of the stents used.		Use of long lesion stents.
All Cause Mortality
	Core Size Registry		Long Lesion Registry
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Core Size Registry		Long Lesion Registry
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	203/412 (49.3%)		49/110 (44.5%)
Blood and lymphatic system disorders
Anaemia	6/412 (1.5%)	6	1/110 (0.9%)	1
Febrile neutropenia	1/412 (0.2%)	1	0/110 (0%)	0
Haemorrhagic anaemia	1/412 (0.2%)	1	1/110 (0.9%)	1
Hypercoagulation	1/412 (0.2%)	1	0/110 (0%)	0
Leukocytosis	1/412 (0.2%)	1	0/110 (0%)	0
Pancytopenia	1/412 (0.2%)	1	0/110 (0%)	0
Cardiac disorders
Acute myocardial infarction	12/412 (2.9%)	13	3/110 (2.7%)	4
Angina pectoris	59/412 (14.3%)	83	16/110 (14.5%)	20
Angina unstable	14/412 (3.4%)	21	6/110 (5.5%)	6
Aortic valve disease	1/412 (0.2%)	1	0/110 (0%)	0
Aortic valve stenosis	1/412 (0.2%)	1	0/110 (0%)	0
Arteriosclerosis coronary artery	1/412 (0.2%)	1	0/110 (0%)	0
Atrial fibrillation	9/412 (2.2%)	10	2/110 (1.8%)	2
Atrioventricular block	1/412 (0.2%)	1	1/110 (0.9%)	1
Atrioventricular block complete	2/412 (0.5%)	2	0/110 (0%)	0
Bradycardia	1/412 (0.2%)	1	0/110 (0%)	0
Cardiac arrest	1/412 (0.2%)	1	0/110 (0%)	0
Cardiac failure acute	1/412 (0.2%)	1	0/110 (0%)	0
Cardiac failure congestive	8/412 (1.9%)	10	2/110 (1.8%)	2
Cardiomyopathy	1/412 (0.2%)	1	0/110 (0%)	0
Chest pain	1/412 (0.2%)	1	0/110 (0%)	0
Coronary artery disease	7/412 (1.7%)	8	0/110 (0%)	0
Coronary artery dissection	3/412 (0.7%)	3	2/110 (1.8%)	2
Coronary artery embolism	1/412 (0.2%)	1	0/110 (0%)	0
Coronary artery occlusion	1/412 (0.2%)	1	0/110 (0%)	0
Coronary artery perforation	1/412 (0.2%)	1	1/110 (0.9%)	1
Coronary artery stenosis	4/412 (1%)	4	1/110 (0.9%)	1
Coronary artery thrombosis	1/412 (0.2%)	1	0/110 (0%)	0
Coronary ostial stenosis	2/412 (0.5%)	2	0/110 (0%)	0
Hypertrophic cardiomyopathy	1/412 (0.2%)	1	0/110 (0%)	0
Intracardiac thrombus	0/412 (0%)	0	1/110 (0.9%)	1
Ischaemic cardiomyopathy	2/412 (0.5%)	3	0/110 (0%)	0
Microvascular angina	1/412 (0.2%)	1	0/110 (0%)	0
Myocardial infarction	3/412 (0.7%)	3	3/110 (2.7%)	3
Myocardial ischaemia	2/412 (0.5%)	2	0/110 (0%)	0
Palpitations	1/412 (0.2%)	1	0/110 (0%)	0
Pericarditis	0/412 (0%)	0	1/110 (0.9%)	1
Post procedural myocardial infarction	0/412 (0%)	0	1/110 (0.9%)	1
Sick sinus syndrome	1/412 (0.2%)	1	0/110 (0%)	0
Sinus bradycardia	1/412 (0.2%)	1	0/110 (0%)	0
Supraventricular tachycardia	2/412 (0.5%)	2	0/110 (0%)	0
Tachycardia	0/412 (0%)	0	1/110 (0.9%)	1
Ventricular extrasystoles	1/412 (0.2%)	1	0/110 (0%)	0
Ventricular fibrillation	0/412 (0%)	0	1/110 (0.9%)	1
Ventricular tachycardia	1/412 (0.2%)	1	1/110 (0.9%)	1
Congenital, familial and genetic disorders
Hydrocele	0/412 (0%)	0	1/110 (0.9%)	1
Gastrointestinal disorders
Abdominal hernia	2/412 (0.5%)	2	0/110 (0%)	0
Abdominal pain	1/412 (0.2%)	1	0/110 (0%)	0
Abdominal pain upper	1/412 (0.2%)	1	0/110 (0%)	0
Barretts oesophagus	0/412 (0%)	0	1/110 (0.9%)	1
Colitis	2/412 (0.5%)	2	0/110 (0%)	0
Diarrhoea haemorrhagic	1/412 (0.2%)	1	0/110 (0%)	0
Diverticulum	0/412 (0%)	0	1/110 (0.9%)	1
Dysphagia	1/412 (0.2%)	1	0/110 (0%)	0
Enterocutaneous fistula	1/412 (0.2%)	1	0/110 (0%)	0
Exomphalos	1/412 (0.2%)	1	0/110 (0%)	0
Faeces discoloured	1/412 (0.2%)	1	0/110 (0%)	0
Haematochezia	0/412 (0%)	0	1/110 (0.9%)	1
Intestinal obstruction	1/412 (0.2%)	1	0/110 (0%)	0
Nausea	1/412 (0.2%)	1	0/110 (0%)	0
Oesophageal spasm	1/412 (0.2%)	1	0/110 (0%)	0
Pancreatitis	1/412 (0.2%)	1	0/110 (0%)	0
Pancreatitis acute	0/412 (0%)	0	1/110 (0.9%)	1
Pharyngoesophageal diverticulum	1/412 (0.2%)	1	0/110 (0%)	0
Rectal haemorrhage	2/412 (0.5%)	2	0/110 (0%)	0
Small intestinal obstruction	2/412 (0.5%)	2	0/110 (0%)	0
Umbilical hernia	0/412 (0%)	0	1/110 (0.9%)	1
General disorders
Asthenia	1/412 (0.2%)	1	0/110 (0%)	0
Catheter site haemorrhage	1/412 (0.2%)	1	0/110 (0%)	0
Non-cardiac chest pain	23/412 (5.6%)	30	6/110 (5.5%)	6
Hepatobiliary disorders
Cholecystitis	1/412 (0.2%)	1	0/110 (0%)	0
Cholelithiasis	2/412 (0.5%)	2	0/110 (0%)	0
Infections and infestations
Abscess	1/412 (0.2%)	1	0/110 (0%)	0
Abscess limb	0/412 (0%)	0	1/110 (0.9%)	2
Acute sinusitis	0/412 (0%)	0	1/110 (0.9%)	1
Breast abscess	1/412 (0.2%)	1	0/110 (0%)	0
Bronchitis	4/412 (1%)	4	0/110 (0%)	0
Cellulitis	2/412 (0.5%)	2	2/110 (1.8%)	3
Clostridial infection	1/412 (0.2%)	1	0/110 (0%)	0
Diverticulitis	1/412 (0.2%)	2	0/110 (0%)	0
Endocarditis	1/412 (0.2%)	1	0/110 (0%)	0
Endocarditis bacterial	1/412 (0.2%)	1	0/110 (0%)	0
Gastroenteritis	1/412 (0.2%)	1	0/110 (0%)	0
Gastroenteritis salmonella	1/412 (0.2%)	1	0/110 (0%)	0
Gastroenteritis viral	1/412 (0.2%)	1	0/110 (0%)	0
Infection	0/412 (0%)	0	1/110 (0.9%)	1
Influenza	1/412 (0.2%)	1	0/110 (0%)	0
Lobar pneumonia	1/412 (0.2%)	1	1/110 (0.9%)	2
Localised infection	1/412 (0.2%)	1	0/110 (0%)	0
Osteomyelitis	1/412 (0.2%)	1	0/110 (0%)	0
Pneumonia	3/412 (0.7%)	3	3/110 (2.7%)	3
Post procedural cellulitis	1/412 (0.2%)	1	0/110 (0%)	0
Rectal abscess	0/412 (0%)	0	1/110 (0.9%)	1
Scrotal abscess	1/412 (0.2%)	1	0/110 (0%)	0
Sepsis	2/412 (0.5%)	2	0/110 (0%)	0
Septic shock	2/412 (0.5%)	2	0/110 (0%)	0
Serratia infection	1/412 (0.2%)	1	0/110 (0%)	0
Sialoadenitis	2/412 (0.5%)	2	0/110 (0%)	0
Wound infection	1/412 (0.2%)	1	0/110 (0%)	0
Injury, poisoning and procedural complications
Anaemia postoperative	1/412 (0.2%)	1	0/110 (0%)	0
Coronary artery restenosis	1/412 (0.2%)	1	0/110 (0%)	0
Device failure	0/412 (0%)	0	1/110 (0.9%)	1
In-stent arterial restenosis	1/412 (0.2%)	2	1/110 (0.9%)	1
In-stent coronary artery restenosis	2/412 (0.5%)	2	2/110 (1.8%)	3
Incisional hernia	2/412 (0.5%)	2	0/110 (0%)	0
Lead dislodgement	0/412 (0%)	0	1/110 (0.9%)	1
Postoperative ileus	1/412 (0.2%)	1	0/110 (0%)	0
Procedural nausea	1/412 (0.2%)	1	0/110 (0%)	0
Stent occlusion	1/412 (0.2%)	1	0/110 (0%)	0
Thrombosis in device	2/412 (0.5%)	2	0/110 (0%)	0
Other injuries	5/412 (1.2%)	5	1/110 (0.9%)	1
Investigations
Cardiac enzymes increased	3/412 (0.7%)	3	1/110 (0.9%)	1
Electrocardiogram ST segment depression	0/412 (0%)	0	1/110 (0.9%)	1
Haematocrit decreased	0/412 (0%)	0	1/110 (0.9%)	1
Pedal pulse decreased	0/412 (0%)	0	1/110 (0.9%)	1
Metabolism and nutrition disorders
Dehydration	1/412 (0.2%)	1	0/110 (0%)	0
Diabetes mellitus inadequate control	0/412 (0%)	0	1/110 (0.9%)	1
Diabetic ketoacidosis	1/412 (0.2%)	1	0/110 (0%)	0
Hypoglycaemia	0/412 (0%)	0	1/110 (0.9%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	4/412 (1%)	5	1/110 (0.9%)	1
Arthritis	3/412 (0.7%)	4	0/110 (0%)	0
Arthropathy	1/412 (0.2%)	1	0/110 (0%)	0
Lumbar spinal stenosis	1/412 (0.2%)	1	1/110 (0.9%)	1
Muscle spasms	1/412 (0.2%)	1	0/110 (0%)	0
Osteoarthritis	10/412 (2.4%)	11	5/110 (4.5%)	6
Osteonecrosis	1/412 (0.2%)	1	0/110 (0%)	0
Pain in extremity	0/412 (0%)	0	1/110 (0.9%)	1
Rotator cuff syndrome	1/412 (0.2%)	1	0/110 (0%)	0
Spinal column stenosis	1/412 (0.2%)	1	0/110 (0%)	0
Spinal disorder	1/412 (0.2%)	1	0/110 (0%)	0
Spinal osteoarthritis	1/412 (0.2%)	1	0/110 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia	1/412 (0.2%)	2	0/110 (0%)	0
Bladder cancer	1/412 (0.2%)	1	0/110 (0%)	0
Breast cancer	1/412 (0.2%)	1	0/110 (0%)	0
Lipoma	1/412 (0.2%)	1	0/110 (0%)	0
Metastases to liver	0/412 (0%)	0	1/110 (0.9%)	1
Metastatic neoplasm	1/412 (0.2%)	1	0/110 (0%)	0
Rectal cancer	0/412 (0%)	0	1/110 (0.9%)	1
Salivary gland cancer	1/412 (0.2%)	2	0/110 (0%)	0
Small intestine carcinoma metastatic	1/412 (0.2%)	1	0/110 (0%)	0
Thyroid neoplasm	1/412 (0.2%)	1	0/110 (0%)	0
Nervous system disorders
Cerebral ischaemia	1/412 (0.2%)	1	0/110 (0%)	0
Cerebral infarction	0/412 (0%)	0	1/110 (0.9%)	1
Cerebrovascular accident	0/412 (0%)	0	1/110 (0.9%)	1
Convulsion	0/412 (0%)	0	1/110 (0.9%)	2
Dementia	0/412 (0%)	0	1/110 (0.9%)	1
Dizziness	2/412 (0.5%)	3	1/110 (0.9%)	1
Guillain-Barre syndrome	1/412 (0.2%)	1	0/110 (0%)	0
Ischaemic stroke	1/412 (0.2%)	1	0/110 (0%)	0
Metabolic encephalopathy	1/412 (0.2%)	1	0/110 (0%)	0
Migraine	1/412 (0.2%)	1	0/110 (0%)	0
Multiple sclerosis	1/412 (0.2%)	1	0/110 (0%)	0
Occipital neuralgia	1/412 (0.2%)	1	0/110 (0%)	0
Paraesthesia	1/412 (0.2%)	1	0/110 (0%)	0
Presyncope	2/412 (0.5%)	2	0/110 (0%)	0
Syncope	7/412 (1.7%)	8	0/110 (0%)	0
Syncope vasovagal	1/412 (0.2%)	1	0/110 (0%)	0
Transient ischaemic attack	2/412 (0.5%)	2	1/110 (0.9%)	1
Tremor	1/412 (0.2%)	1	0/110 (0%)	0
Vertigo	1/412 (0.2%)	1	0/110 (0%)	0
Vertigo positional	1/412 (0.2%)	1	0/110 (0%)	0
Psychiatric disorders
Alcoholism	1/412 (0.2%)	1	0/110 (0%)	0
Bipolar disorder	1/412 (0.2%)	1	0/110 (0%)	0
Confusional state	1/412 (0.2%)	1	1/110 (0.9%)	1
Intentional overdose	1/412 (0.2%)	1	0/110 (0%)	0
Major depression	3/412 (0.7%)	3	0/110 (0%)	0
Renal and urinary disorders
Renal failure acute	2/412 (0.5%)	2	1/110 (0.9%)	1
Other renal and urinary disorders	6/412 (1.5%)	7	3/110 (2.7%)	3
Reproductive system and breast disorders
Benign prostatic hyperplasia	1/412 (0.2%)	1	0/110 (0%)	0
Uterine polyp	1/412 (0.2%)	1	0/110 (0%)	0
Vaginal prolapse	0/412 (0%)	0	1/110 (0.9%)	1
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	2/412 (0.5%)	3	0/110 (0%)	0
Dyspnoea	7/412 (1.7%)	7	2/110 (1.8%)	2
Dyspnoea exertional	3/412 (0.7%)	3	0/110 (0%)	0
Lung disorder	1/412 (0.2%)	1	0/110 (0%)	0
Pulmonary embolism	1/412 (0.2%)	1	0/110 (0%)	0
Respiratory failure	1/412 (0.2%)	1	1/110 (0.9%)	1
Wegeners granulomatosis	1/412 (0.2%)	1	0/110 (0%)	0
Surgical and medical procedures
Knee arthroplasty	1/412 (0.2%)	2	0/110 (0%)	0
Knee operation	1/412 (0.2%)	1	0/110 (0%)	0
Vascular disorders
Arteriosclerosis	3/412 (0.7%)	4	0/110 (0%)	0
Carotid artery stenosis	4/412 (1%)	4	1/110 (0.9%)	1
Deep vein thrombosis	4/412 (1%)	4	0/110 (0%)	0
Duodenal ulcer haemorrhage	1/412 (0.2%)	1	0/110 (0%)	0
Epistaxis	0/412 (0%)	0	1/110 (0.9%)	1
Femoral artery occlusion	0/412 (0%)	0	2/110 (1.8%)	3
Gastrointestinal haemorrhage	3/412 (0.7%)	3	0/110 (0%)	0
Haematoma	1/412 (0.2%)	1	0/110 (0%)	0
Haemoptysis	1/412 (0.2%)	1	0/110 (0%)	0
Hypertension	1/412 (0.2%)	1	3/110 (2.7%)	3
Hypertensive crisis	2/412 (0.5%)	2	0/110 (0%)	0
Hypotension	1/412 (0.2%)	1	0/110 (0%)	0
Iliac artery stenosis	1/412 (0.2%)	1	0/110 (0%)	0
Intermittent claudication	1/412 (0.2%)	1	1/110 (0.9%)	1
Malignant hypertension	1/412 (0.2%)	1	0/110 (0%)	0
Mallory-Weiss syndrome	1/412 (0.2%)	1	0/110 (0%)	0
Orthostatic hypotension	0/412 (0%)	0	1/110 (0.9%)	2
Peripheral artery dissection	1/412 (0.2%)	1	0/110 (0%)	0
Peripheral ischaemia	1/412 (0.2%)	1	0/110 (0%)	0
Peripheral vascular disorder	2/412 (0.5%)	2	2/110 (1.8%)	2
Post procedural haemorrhage	1/412 (0.2%)	1	0/110 (0%)	0
Pulmonary embolism	2/412 (0.5%)	2	0/110 (0%)	0
Scrotal haematocoele	1/412 (0.2%)	1	0/110 (0%)	0
Subarachnoid haemorrhage	1/412 (0.2%)	1	0/110 (0%)	0
Subdural haematoma	0/412 (0%)	0	1/110 (0.9%)	1
Upper gastrointestinal haemorrhage	1/412 (0.2%)	1	0/110 (0%)	0
Vascular pseudoaneurysm	1/412 (0.2%)	1	1/110 (0.9%)	1
Other (Not Including Serious) Adverse Events
	Core Size Registry		Long Lesion Registry
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	222/412 (53.9%)		51/110 (46.4%)
Cardiac disorders
Angina pectoris	89/412 (21.6%)	114	20/110 (18.2%)	24
Coronary artery dissection	11/412 (2.7%)	11	9/110 (8.2%)	9
General disorders
Catheter site haematoma	21/412 (5.1%)	21	5/110 (4.5%)	5
Fatigue	25/412 (6.1%)	25	3/110 (2.7%)	3
Non-cardiac chest pain	71/412 (17.2%)	77	13/110 (11.8%)	14
Catheter site haemorrhage	15/412 (3.6%)	16	6/110 (5.5%)	6
Musculoskeletal and connective tissue disorders
Back pain	24/412 (5.8%)	28	7/110 (6.4%)	7
Nervous system disorders
Headache	27/412 (6.6%)	27	3/110 (2.7%)	6
Respiratory, thoracic and mediastinal disorders
Dyspnoea	26/412 (6.3%)	27	3/110 (2.7%)	3
Vascular disorders
Hypertension	11/412 (2.7%)	12	6/110 (5.5%)	6

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication except to delay any proposed publication or presentation to enable the Sponsor to secure patent or other protection of proprietary rights.