SV JAPAN: A Clinical Evaluation of the XIENCE PRIME Small Vessel Everolimus Eluting Coronary Stent System in Japanese Population

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01115933
• Collaborator: (none)
• Enrollment: 65
• Locations: 14
• Arm: 1
• Duration (Months): 44
• Patients Per Site: 4.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the AVJ-09-385 Small Vessel Everolimus Eluting Coronary Stent System (EECSS) (2.25 mm diameter stent) in treatment of subjects with ischemic heart disease caused by de novo lesions.

Condition or Disease	Intervention/Treatment	Phase
Vascular Disease; Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis	Device: XIENCE PRIME SV EECSS	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: SPIRIT PRIME JAPAN (SV JAPAN)
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: XIENCE PRIME SV EECSS XIENCE PRIME SV EECSS: Small Vessel Everolimus Eluting Coronary Stent System	Device: XIENCE PRIME SV EECSS; Patients receiving XIENCE PRIME SV EECSS

Outcome Measures

Primary Outcome Measures

1. Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF) [9 Months]

   Target lesion failure (TLF) is the composite of any of the following adverse events: Cardiac death, target vessel myocardial infarction (TV-MI) (per Protocol definition), Clinically indicated target lesion revascularization (CI-TLR)

Secondary Outcome Measures

1. Device Success (Lesion Based Analysis, Only for XIENCE PRIME SV) [The period during an in-hospital stay of less than or equal to 7 days post index procedure.]

   Device success is achievement final in-stent residual diameter stenosis of < 50% (by QCA). If adjunct treatment devices other than protocol defined device is used for target lesion treatment, malfunction of the investigational device occurring during the index procedure, are not regarded as device success. Use of a bail-out stent is still regarded as device success unless a device malfunction has occured. If QCA %DS is not available, the data is not included in analyses.

2. Procedural Success(Subject Base Analysis) [The period during an in-hospital stay of less than or equal to 7 days post index procedure.]

   Procedure success is defined as achievement of a final in-stent diameter stenosis of < 50% (by QCA) using the investigational device (AVJ-09-385), without the occurrence MACE during the hospital stay (up to 7 days if a subject still in the hospital). If QCA %DS is not available, the data is not included in analyses.

3. Percent Diameter Stenosis (%DS), In-segment, In-stent, Proximal and Distal [8 months]

   IN-STENT is defined as within the margins of the stent. IN-SEGMENT is defined as within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. PROXIMAL is defined as within 5 mm of healthy tissue proximal to stent placement DISTAL is defined as within 5 mm of healthy tissue distal to stent placement

4. Late Loss (LL), In-segment, In-stent, Proximal and Distal [8 months]

   LATE LOSS (LL) calculated as MINIMUM LUMEN DIAMETER [MLD] post-procedure MINUS MLD at follow-up: In-segment Late Loss: in-segment MLD post-procedure - in segment MLD at follow-up In-stent Late Loss: in-stent MLD post-procedure - in-stent MLD at follow-up Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to stent placement) Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to stent placement)

5. Angiographic Binary Restenosis (ABR), In-segment, In-stent, Proximal and Distal [8 months]

   IN-STENT is defined as within the margins of the stent. IN-SEGMENT is defined as within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. PROXIMAL is defined as within 5 mm of healthy tissue proximal to stent placement DISTAL is defined as within 5 mm of healthy tissue distal to stent placement

6. Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition) [1 month]

   DEATH (Per ARC Circulation 2007; 115: 2344-2351) All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

7. Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition) [9 months]

   DEATH (Per ARC Circulation 2007; 115: 2344-2351) All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

8. Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) [1 month]

   Definitions in SPIRIT III Study: Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351

9. Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) [9 months]

   Definitions in SPIRIT III Study: Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351

10. Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI) [1 month]

    Definitions in SPIRIT III Study: Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351

11. Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI) [9 months]

    Definitions in SPIRIT III Study: Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351

12. Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI) [1 month]

    Definitions in SPIRIT III Study: Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351

13. Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI) [9 months]

    Definitions in SPIRIT III Study: Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351

14. Target Lesion Revascularization (TLR, Per ARC Definition) [1 month]

    Any revascularization for in-segment restenosis will be considered TLR."Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.

15. Target Lesion Revascularization (TLR, Per ARC Definition) [9 months]

    Any revascularization for in-segment restenosis will be considered TLR. "Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.

16. Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR) [1 month]

    Any revascularization for in-segment restenosis will be considered TLR. "Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.

17. Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR) [9 months]

    Any revascularization for in-segment restenosis will be considered TLR. "Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.

18. Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR) [1 month]

    Any revascularization for in-segment restenosis will be considered TLR. "Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.

19. Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR) [9 months]

    Any revascularization for in-segment restenosis will be considered TLR. "Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.

20. Target Vessel Revascularization (TVR, Per ARC Definition) [1 month]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.

21. Target Vessel Revascularization (TVR, Per ARC Definition) [9 months]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.

22. Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR) [1 month]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.

23. Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR) [9 months]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.

24. Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR) [1 month]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.

25. Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR) [9 months]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.

26. Composite Endpoint of Cardiac Death/All MI [1 month]

27. Composite Endpoint of Cardiac Death/All MI [9 months]

28. Composite Endpoint of All Death/All MI/All Revascularization (DMR) [1 month]

    DMR event (all death, all MI (per protocol or per ARC), all revascularization, respectively).

29. Composite Endpoint of All Death/All MI/All Revascularization (DMR) [9 months]

    DMR event (all death, all MI (per protocol or per ARC), all revascularization, respectively).

30. Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF) [1 month]

    Target lesion failure (TLF) is defined as a composite of cardiac death, target-vessel related myocardial infarction (TV-MI) and clinically-indicated target lesion revascularization (CI-TLR).

31. Composite Endpoint of Cardiac Death/All MI/CI-TLR (MACE) [1 month]

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).

32. Composite Endpoint of Cardiac Death, All MI and CI-TLR (MACE) [9 months]

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).

33. All Coronary Revascularization [1 months]

34. All Coronary Revascularization [9 months]

35. Acute Stent Thrombosis [<24 hours]

    Stent thrombosis (ST) was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement."

36. Subacute Stent Thrombosis [1-30 days]

    Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement."

37. Acute/Subacute Stent Thrombosis [0-30 days]

    Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement."

38. Late Stent Thrombosis [31 - 298 days]

    Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement."

39. Overall Stent Thrombosis [0 - 298 days]

    Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement."

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject must be at least 20 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 (target) or two (one target and one non-target) de novo lesions each in a different epicardial vessel.

2. 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.

3. Lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of ≥ 2.25 mm and < 2.5 mm.

4. Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 22 mm.

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) < 40% (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.

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, warfarin).

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

12. Subject has a known hypersensitivity or contraindication to aspirin, heparin, 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 6 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 serum creatinine level ≥ 2.0 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 5 French catheter insertion.

20. Subject has other medical illness (e.g., cancer) 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*.

• Whether a subject who met this criterion will be asked for pregnancy test will be decided per site standard. However, subject enrollment in the study is not allowed without pregnancy test result.

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 guidewire, 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 lesion.

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

7. Lesion in the left main trunk (both target and non-target).

8. 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 target 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. rotablator, DCA, cutting balloon).

13. Target vessel is previously treated* with any type of PCI (e.g. balloon angioplasty, stent, rotablator, DCA, cutting balloon) within 9 months of index procedure.

14. Non-target vessel was previously treated with any type of PCI within 90 days of index procedure.

15. Additional clinically significant lesion(s) in the target vessel or side branch for which PCI may be required within 90 days after the index procedure.

• Target lesion must be separated ≥ 5 mm from a previously treated lesion (stenosis within 5 mm of previously treated lesion is regarded as "restenosis").

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kokura Memorial Hospital	Kita-kyushu	Fukuoka	Japan
2	Hokkaido Social Insurance Hospital Cardiovascular Center	Toyohira	Hokkaido	Japan
3	Teikyo University	Tokyo	Itabashi	Japan
4	Tokai University Hospital	Isehara	Kanagawa	Japan
5	Shonan Kamakura General Hospital	Kamakura	Kanagawa	Japan
6	Saiseikai Yokohama City Eastern Hospital	Yokohama	Kanagawa	Japan
7	Kyoto University Hospital	Sakyo-ku	Kyoto	Japan
8	Sendai Kousei Hospital	Sendai	Miyagi	Japan
9	Nagoya Daini Red Cross Hospital	Showa-ku	Nagoya	Japan
10	Kurashiki Central Hospital	Kurashiki	Okayama	Japan
11	Sakurabashi Watanabe Hospital	Kita-ku	Osaka	Japan
12	Osaka University Hospital	Suita	Osaka	Japan
13	Tokushima Red Cross Hospital	Komatsushima	Tokushima	Japan
14	Kumamoto Central Hospital	Kumamoto		Japan

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Takaaki Isshiki, MD, Teikyo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01115933
• Other Study ID Numbers: 09-385
• First Posted: May 4, 2010
• Last Update Posted: Aug 13, 2015
• Last Verified: Jun 1, 2015

• Keywords provided by Abbott Medical Devices: drug eluting stents; small vessel; Stents; Everolimus; Angioplasty
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Vascular Diseases; Coronary Stenosis; Coronary Restenosis; Ischemia

Study Results

Participant Flow

Recruitment Details	A total of 65 subjects at 15 Japanese sites were enrolled between April, 2010 and August, 2011.

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV EECSS: XIENCE PRIME Small Vessel (2.25 mm) Everolimus Eluting Coronary Stent System XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
Period Title: Overall Study
STARTED	65
COMPLETED	64
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV Everolimus Eluting Coronary Stent System XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Overall Participants	64
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	15 23.4%
>=65 years	49 76.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.63 (7.65)
Sex: Female, Male (Count of Participants)
Female	15 23.4%
Male	49 76.6%
Region of Enrollment (participants) [Number]
Japan	64 100%

Outcome Measures

1. Primary Outcome

Title	Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF)
Description	Target lesion failure (TLF) is the composite of any of the following adverse events: Cardiac death, target vessel myocardial infarction (TV-MI) (per Protocol definition), Clinically indicated target lesion revascularization (CI-TLR)
Time Frame	9 Months

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS population)

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64
Number [percentage of participants]	0.00 0%

2. Secondary Outcome

Title	Device Success (Lesion Based Analysis, Only for XIENCE PRIME SV)
Description	Device success is achievement final in-stent residual diameter stenosis of < 50% (by QCA). If adjunct treatment devices other than protocol defined device is used for target lesion treatment, malfunction of the investigational device occurring during the index procedure, are not regarded as device success. Use of a bail-out stent is still regarded as device success unless a device malfunction has occured. If QCA %DS is not available, the data is not included in analyses.
Time Frame	The period during an in-hospital stay of less than or equal to 7 days post index procedure.

Outcome Measure Data

Analysis Population Description

Intent to Treat Population (ITT)

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	65
Number (95% Confidence Interval) [percentage of participants]	100.00 156.3%

3. Secondary Outcome

Title	Procedural Success(Subject Base Analysis)
Description	Procedure success is defined as achievement of a final in-stent diameter stenosis of < 50% (by QCA) using the investigational device (AVJ-09-385), without the occurrence MACE during the hospital stay (up to 7 days if a subject still in the hospital). If QCA %DS is not available, the data is not included in analyses.
Time Frame	The period during an in-hospital stay of less than or equal to 7 days post index procedure.

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV EECSS EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	65
Number (95% Confidence Interval) [percentage of participants]	100.00 156.3%

4. Secondary Outcome

Title	Percent Diameter Stenosis (%DS), In-segment, In-stent, Proximal and Distal
Description	IN-STENT is defined as within the margins of the stent. IN-SEGMENT is defined as within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. PROXIMAL is defined as within 5 mm of healthy tissue proximal to stent placement DISTAL is defined as within 5 mm of healthy tissue distal to stent placement
Time Frame	8 months

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS population)

Arm/Group Title	XIENCE PRIME SV EECSS %DS In-segment	XIENCE PRIME SV EECSS %DS In-stent	XIENCE PRIME SV EECSS %DS Proximal	XIENCE PRIME SV EECSS %DS Distal
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64	64	64	64
Mean (Standard Deviation) [percentage of DS]	19.80 (10.59)	6.11 (11.65)	12.32 (17.03)	14.91 (8.12)

5. Secondary Outcome

Title	Late Loss (LL), In-segment, In-stent, Proximal and Distal
Description	LATE LOSS (LL) calculated as MINIMUM LUMEN DIAMETER [MLD] post-procedure MINUS MLD at follow-up: In-segment Late Loss: in-segment MLD post-procedure - in segment MLD at follow-up In-stent Late Loss: in-stent MLD post-procedure - in-stent MLD at follow-up Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to stent placement) Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to stent placement)
Time Frame	8 months

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS population)

Arm/Group Title	XIENCE PRIME SV EECSS LL In-segment	XIENCE PRIME SV EECSS LL In-stent	XIENCE PRIME SV EECSS LL Proximal	XIENCE PRIME SV EECSS LL Distal
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS: Patients receivingXIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64	64	64	64
Mean (Standard Deviation) [mm]	0.12 (0.24)	0.13 (0.25)	0.08 (0.30)	0.08 (0.25)

6. Secondary Outcome

Title	Angiographic Binary Restenosis (ABR), In-segment, In-stent, Proximal and Distal
Description	IN-STENT is defined as within the margins of the stent. IN-SEGMENT is defined as within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. PROXIMAL is defined as within 5 mm of healthy tissue proximal to stent placement DISTAL is defined as within 5 mm of healthy tissue distal to stent placement
Time Frame	8 months

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS population)

Arm/Group Title	XIENCE PRIME SV EECSS ABR In-segment	XIENCE PRIME SV EECSS ABR In-stent	XIENCE PRIME SV EECSS ABR Proximal	XIENCE PRIME SV EECSS ABR Distal
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Measure Participants	64	64	64	64
Number (95% Confidence Interval) [percentage of participants]	4.8 7.5%	0 NaN	3.7 NaN	0 NaN

7. Secondary Outcome

Title	Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition)
Description	DEATH (Per ARC Circulation 2007; 115: 2344-2351) All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE PRIME SV EECSS - Cardiac	XIENCE PRIME SV EECSS - Vascular	XIENCE PRIME SV EECSS - Non-Cardiovascular
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving AXIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Measure Participants	64	64	64
Number [percentage of participants]	0.00 0%	0.00 NaN	0.00 NaN

8. Secondary Outcome

Title	Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition)
Description	DEATH (Per ARC Circulation 2007; 115: 2344-2351) All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS population)

Arm/Group Title	XIENCE PRIME SV EECSS - All Death Per ARC	XIENCE PRIME SV EECSS - Cardiac Death Per ARC	XIENCE PRIME SV EECSS - Vascular Death Per ARC	XIENCE PRIME SV EECSS - Non-Cardiovascular Death Per ARC
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving AXIENCE PRIME SV EECSS
Measure Participants	64	64	64	64
Number [percentage of participants]	1.6 2.5%	0.00 NaN	0.00 NaN	1.6 NaN

9. Secondary Outcome

Title	Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions)
Description	Definitions in SPIRIT III Study: Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS population)

Arm/Group Title	XIENCE PRIME SV EECSS - QMI Per Protocol	XIENCE PRIME SV EECSS - NQMI Per Protocol	XIENCE PRIME SV EECSS - QMI Per ARC Definitions	XIENCE PRIME SV EECSS - NQMI Per ARC Definitions
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64	64	64	64
Number [percentage of participants]	0.00 0%	0.00 NaN	0.00 NaN	0.00 NaN

10. Secondary Outcome

Title	Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions)
Description	Definitions in SPIRIT III Study: Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS population)

Arm/Group Title	XIENCE PRIME SV EECSS - QMI Per Protocol	XIENCE PRIME SV EECSS - NQMI Per Protocol	XIENCE PRIME SV EECSS - QMI Per ARC	XIENCE PRIME SV EECSS - NQMI Per ARC
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64	64	64	64
Number [percentage of participants]	0.00 0%	0.00 NaN	0.00 NaN	0.00 NaN

11. Secondary Outcome

Title	Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI)
Description	Definitions in SPIRIT III Study: Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS population)

Arm/Group Title	XIENCE PRIME SV EECSS- TV-QMI Per Protocol	XIENCE PRIME SV EECSS - TV-NQMI Per Protocol	XIENCE PRIME SV EECSS - TV-QMI Per ARC	XIENCE PRIME SV EECSS - TV-NQMI Per ARC
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64	64	64	64
Number [percentage of participants]	0.00 0%	0.00 NaN	0.00 NaN	0.00 NaN

12. Secondary Outcome

Title	Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI)
Description	Definitions in SPIRIT III Study: Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS population)

Arm/Group Title	XIENCE PRIME SV EECSS - TV-QMI Per Protocol	XIENCE PRIME SV EECSS - TV-NQMI Per Protocol	XIENCE PRIME SV EECSS - TV-QMI Per ARC	XIENCE PRIME SV EECSS - TV-NQMI Per ARC
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64	64	64	64
Number [percentage of participants]	0.00 0%	0.00 NaN	0.00 NaN	0.00 NaN

13. Secondary Outcome

Title	Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI)
Description	Definitions in SPIRIT III Study: Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

FAS Population

Arm/Group Title	XIENCE PRIME SV EECSS Non-Target Vessel QMI Per Protocol	XIENCE PRIME SV EECSS Non-Target Vessel NQMI Per Protocol	XIENCE PRIME SV EECSS Non-Target Vessel QMI Per ARC	XIENCE PRIME SV EECSS Non-Target Vessel NQMI Per ARC
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64	64	64	64
Number [percentage of participants]	0 0%	0 NaN	0 NaN	0 NaN

14. Secondary Outcome

Title	Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI)
Description	Definitions in SPIRIT III Study: Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS population)

Arm/Group Title	XIENCE PRIME SV EECSS - NTV-QMI Per Protocol	XIENCE PRIME SV EECSS - NTV-NQMI Per Protocol	XIENCE PRIME SV EECSS - NTV-QMI Per ARC	XIENCE PRIME SV EECSS - NTV-NQMI Per ARC
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64	64	64	64
Number [percentage of participants]	0.00 0%	0.00 NaN	0.00 NaN	0.00 NaN

15. Secondary Outcome

Title	Target Lesion Revascularization (TLR, Per ARC Definition)
Description	Any revascularization for in-segment restenosis will be considered TLR."Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) population

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64
Number [percentage of participants]	0.00 0%

16. Secondary Outcome

Title	Target Lesion Revascularization (TLR, Per ARC Definition)
Description	Any revascularization for in-segment restenosis will be considered TLR. "Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

FAS Population

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64
Number [percentage of participants]	3.1 4.8%

17. Secondary Outcome

Title	Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR)
Description	Any revascularization for in-segment restenosis will be considered TLR. "Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) population

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64
Number [percentage of participants]	0.00 0%

18. Secondary Outcome

Title	Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR)
Description	Any revascularization for in-segment restenosis will be considered TLR. "Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS population)

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64
Number [percentage of participants]	0.00 0%

19. Secondary Outcome

Title	Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR)
Description	Any revascularization for in-segment restenosis will be considered TLR. "Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) population

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64
Number [percentage of participants]	0.00 0%

20. Secondary Outcome

Title	Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR)
Description	Any revascularization for in-segment restenosis will be considered TLR. "Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

FAS population

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64
Number [percentage of participants]	3.1 4.8%

21. Secondary Outcome

Title	Target Vessel Revascularization (TVR, Per ARC Definition)
Description	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

FAS Population

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64
Number [percentage of participants]	0 0%

22. Secondary Outcome

Title	Target Vessel Revascularization (TVR, Per ARC Definition)
Description	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

FAS population

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64
Number [percentage of participants]	3.1 4.8%

23. Secondary Outcome

Title	Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR)
Description	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) population

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64
Number [percentage of participants]	0.00 0%

24. Secondary Outcome

Title	Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR)
Description	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS population)

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64
Number [percentage of participants]	1.6 2.5%

25. Secondary Outcome

Title	Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR)
Description	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS population)

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64
Number [percentage of participants]	0.00 0%

26. Secondary Outcome

Title	Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR)
Description	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS population)

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64
Number [percentage of participants]	3.1 4.8%

27. Secondary Outcome

Title	Composite Endpoint of Cardiac Death/All MI
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS population)

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64
Number [percentage of participants]	0.00 0%

28. Secondary Outcome

Title	Composite Endpoint of Cardiac Death/All MI
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS population)

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64
Number [percentage of participants]	0.0 0%

29. Secondary Outcome

Title	Composite Endpoint of All Death/All MI/All Revascularization (DMR)
Description	DMR event (all death, all MI (per protocol or per ARC), all revascularization, respectively).
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS population)

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64
Number [percentage of participants]	0.00 0%

30. Secondary Outcome

Title	Composite Endpoint of All Death/All MI/All Revascularization (DMR)
Description	DMR event (all death, all MI (per protocol or per ARC), all revascularization, respectively).
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS population)

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64
Number [percentage of participants]	10.9 17%

31. Secondary Outcome

Title	Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF)
Description	Target lesion failure (TLF) is defined as a composite of cardiac death, target-vessel related myocardial infarction (TV-MI) and clinically-indicated target lesion revascularization (CI-TLR).
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

FAS population

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64
Number [percentage of participants]	0.00 0%

32. Secondary Outcome

Title	Composite Endpoint of Cardiac Death/All MI/CI-TLR (MACE)
Description	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS population)

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64
Number [percentage of participants]	0.00 0%

33. Secondary Outcome

Title	Composite Endpoint of Cardiac Death, All MI and CI-TLR (MACE)
Description	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

FAS population

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64
Number [percentage of participants]	0.0 0%

34. Secondary Outcome

Title	All Coronary Revascularization
Time Frame	1 months

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS population)

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64
Number [percentage of participants]	0.00 0%

35. Secondary Outcome

Title	All Coronary Revascularization
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

FAS population

Arm/Group Title	XIENCE PRIME SV EECSS
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64
Number [percentage of participants]	0.0 0%

36. Secondary Outcome

Title	Acute Stent Thrombosis
Description	Stent thrombosis (ST) was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement."
Time Frame	<24 hours

Outcome Measure Data

Analysis Population Description

FAS population

Arm/Group Title	XIENCE PRIME SV EECSS - ST Definite	XIENCE PRIME SV EECSS - ST Probable	XIENCE PRIME SV EECSS - ST Possible	XIENCE PRIME SV EECSS - ST Definite/Probable	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Measure Participants	64	64	64	64	64
Number [percentage of participants]	0.0 0%	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN

37. Secondary Outcome

Title	Subacute Stent Thrombosis
Description	Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement."
Time Frame	1-30 days

Outcome Measure Data

Analysis Population Description

FAS population

Arm/Group Title	XIENCE PRIME SV EECSS - ST Definite	XIENCE PRIME SV EECSS - ST Probable	XIENCE PRIME SV EECSS - ST Possible	XIENCE PRIME SV EECSS - ST Definite/Probable	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64	64	64	64	64
Number [percentage of participants]	0.0 0%	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN

38. Secondary Outcome

Title	Acute/Subacute Stent Thrombosis
Description	Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement."
Time Frame	0-30 days

Outcome Measure Data

Analysis Population Description

FAS population

Arm/Group Title	XIENCE PRIME SV EECSS - ST Definite	XIENCE PRIME SV EECSS - ST Probable	XIENCE PRIME SV EECSS - ST Possible	XIENCE PRIME SV EECSS - ST Definite/Probable	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible
Arm/Group Description	XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64	64	64	64	64
Number [percentage of participants]	0.0 0%	0.0 NaN	0.00 NaN	0.00 NaN	0.0 NaN

39. Secondary Outcome

Title	Late Stent Thrombosis
Description	Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement."
Time Frame	31 - 298 days

Outcome Measure Data

Analysis Population Description

FAS population

Arm/Group Title	XIENCE PRIME SV EECSS - ST Definite	XIENCE PRIME SV EECSS- ST Probable	XIENCE PRIME SV EECSS - ST Possible	XIENCE PRIME SV EECSS - ST Definite/Probable	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64	64	64	64	64
Number [percentage of participants]	0.0 0%	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN

40. Secondary Outcome

Title	Overall Stent Thrombosis
Description	Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement."
Time Frame	0 - 298 days

Outcome Measure Data

Analysis Population Description

FAS population

Arm/Group Title	XIENCE PRIME SV EECSS - ST Definite	XIENCE PRIME SV EECSS - ST Probable	XIENCE PRIME SV EECSS - ST Possible	XIENCE PRIME SV EECSS - ST Definite/Probable	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible
Arm/Group Description	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS: Small Vessel Everolimus Eluting Coronary Stent System XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Measure Participants	64	64	64	64	64
Number [percentage of participants]	0.0 0%	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN

Adverse Events

Time Frame	Nine (9) month post procedure data which includes events which occurred up to 298 days.
Arm/Group Title	AVJ-09-385 SV EECSS
Arm/Group Description	SV EECSS: Small Vessel Everolimus Eluting Coronary Stent System AVJ-09-385 EECSS : Patients receiving AVJ-09-385 EECSS
All Cause Mortality
	AVJ-09-385 SV EECSS
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	AVJ-09-385 SV EECSS
	Affected / at Risk (%)	# Events
Total	10/64 (15.6%)
Cardiac disorders
Angina unstable	1/64 (1.6%)	1
Angina pectoris	2/64 (3.1%)	2
Coronary artery stenosis	1/64 (1.6%)	1
Eye disorders
	1/64 (1.6%)	1
Infections and infestations
	1/64 (1.6%)	1
Injury, poisoning and procedural complications
Coronary artery restenosis	2/64 (3.1%)	2
Musculoskeletal and connective tissue disorders
	1/64 (1.6%)	1
Nervous system disorders
Cerebral haemorrhage	1/64 (1.6%)	1
Other (Not Including Serious) Adverse Events
	AVJ-09-385 SV EECSS
	Affected / at Risk (%)	# Events
Total	4/64 (6.3%)
Infections and infestations
hordeolum, influenza, nasopharyngitis	4/64 (6.3%)	4

Limitations/Caveats

[Not Specified]

More Information

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. The sponsor cannot require changes to the communication and cannot extend the embargo.