Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE)

• Sponsor: Cardiovascular Systems Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01930214
• Collaborator: (none)
• Enrollment: 350
• Locations: 34
• Actual Duration (Months): 44.2
• Patients Per Site: 10.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The objective of this study is to assess the current standard of care treatment outcome in none/mild, moderate and severely calcified coronary lesions using:

• A composite of MACE at 30-day and one (1) year post procedure, and

• Procedural and lesion success

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: Percutaneous Coronary Intervention

Detailed Description

This prospective, non-randomized, multi-center study includes subjects who meet all of the inclusion and none of the exclusion criteria and sign the ICF. This study may treat up to approximately 500 subjects at up to 50 active sites in the U.S. Subjects may be followed up to three (3) years. Subjects will be stratified into one (1) of three (3) arms based on the degree of calcification in the coronary lesion as defined by this protocol. The duration of the study is expected to be approximately four (4) years.

Study Design

• Study Type: Observational
• Actual Enrollment: 350 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE)
• Actual Study Start Date: Sep 26, 2013
• Actual Primary Completion Date: Nov 7, 2016
• Actual Study Completion Date: Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
None/mild calcification Presence of readily apparent radiopacities within the vascular wall at the site of the stenosis.	Device: Percutaneous Coronary Intervention; Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).
Moderate Calcification Presence of radiopacities only during the cardiac cycle before contrast injection with calcium extended partially into the target lesion.	Device: Percutaneous Coronary Intervention; Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).
Severe calcification Presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location, total length of calcium (including segmented) must be at least 15mm and extend partially into the target lesion.	Device: Percutaneous Coronary Intervention; Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).

Outcome Measures

Primary Outcome Measures

1. MACE at 30 Days [30 days post procedure]

   A Kaplan-Meier analysis was performed to determine the percent probability that a study participant experienced a major adverse cardiac event through 30 days. 30-day MACE is composed of: Cardiac death Myocardial Infarction (MI) - defined as a Creatine Kinase Myocardial-Band Isoenzyme (CK-MB) level greater than three (3) times the Upper Limit of Lab Normal (ULN) value with or without new pathologic Q wave Target Vessel Revascularization (TVR) - defined as a revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure

Secondary Outcome Measures

1. MACE at One (1) Year [One (1) year post procedure]

   A Kaplan-Meier analysis was performed to determine the percent probability that a study participant experienced a major adverse cardiac event through 1 year. 1-year MACE is composed of: Cardiac death Myocardial Infarction (MI) - defined as a Creatine Kinase Myocardial-Band Isoenzyme (CK-MB) level greater than three (3) times the Upper Limit of Lab Normal (ULN) value with or without new pathologic Q wave Target Vessel Revascularization (TVR) - defined as a revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure

2. Procedural Success [Participants were followed from baseline procedure through hospital discharge, an expected average of 24 hours]

   Procedural success is defined as success in facilitating stent delivery with a residual stenosis of <50% and without the occurrence of an in-hospital MACE.

3. Lesion Success [During the procedure]

   Lesion success is defined as success in facilitating stent delivery with a post-procedural result of <50% residual stenosis for a given lesion treated during the procedure without severe angiographic complications.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

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

2. Subjects must be scheduled for percutaneous coronary revascularization involving stent deployment in de novo coronary lesions. Percutaneous coronary revascularization is defined as treatment with commercially available devices that may include but not limited to balloon angioplasty, cutting balloon, rotablation, etc. followed by the stent placement.

3. Subjects CK-MB must be less than or equal to the upper limit of lab normal value within eight (8) hours prior to procedure. If CK-MB results are not yet available prior to initiating procedure, subjects Troponin I or Troponin T must be less than or equal to the upper limit of lab normal value within eight (8) hours prior to the procedure.

4. The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure.

5. The target vessel must be a native coronary artery with:

6. A stenosis ≥ 70% and < 100%, or

7. A stenosis ≥ 50% < 70% with evidence of clinical ischemia

8. The target vessel reference diameter must be ≥ 2.5mm and ≤ 4.0 mm.

9. The lesion length must not exceed 40 mm.

10. The target vessel must have a Thrombolysis In Myocardial Infarction (TIMI) flow three (3) at baseline.

Exclusion Criteria:

1. Inability to understand the study or a history of non-compliance with medical advice.

2. Unwilling or unable to sign the MACE clinical study ICF.

3. History of any cognitive or mental health status that would interfere with study participation.

4. Currently enrolled in any other pre-approval investigational study. This does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.).

5. Female subjects who are pregnant or planning to become pregnant within the study period.

6. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel without adequate alternative medications.

7. Known sensitivity to contrast media, which cannot be adequately pre-medicated.

8. Diagnosed with chronic renal failure unless under hemodialysis, or has a serum creatinine level >2.5 mg/dl.

9. History of major cardiac intervention within 30-day, not including a PCI procedure for a staging purpose.

10. Evidence of heart failure by one of the following:

1. Left Ventricular Ejection Fraction (LVEF) ≤ 25% ii. New York Heart Association (NYHA) class III or IV iii. Clinical symptoms

1. History of a stroke or transient ischemic attack (TIA) within six (6) months

2. Active peptic ulcer or upper gastrointestinal (GI) bleeding within six (6) months.

3. History of bleeding diathesis or coagulopathy or intention to refuse blood transfusion if one should become necessary.

4. Concurrent medical condition with a life expectancy of < 36 months.

5. History of immune deficiency.

6. Uncontrolled insulin dependent diabetes.

7. Evidence of active infections on the day of the index procedure.

8. Subject has planned cardiovascular intervention within 60 days post index procedure.

9. Subject with angiographically confirmed evidence of more than two (2) lesions within one (1) vessel or more than one (1) vessel requiring intervention, unless the treatment is staged. See Section 10.1 for more details.

10. Target lesion is located in a native vessel distal to anastomosis with a saphenous vein graft or Left Internal Mammary Artery/ Right Internal Mammary Artery (LIMA/RIMA) bypass.

11. Target vessel has angiographically visible or suspected thrombus.

12. Target vessel appears to be/is excessively tortuous at baseline.

13. Target lesion is an ostial location (within 5mm of ostium) or an unprotected left main lesion.

14. Target lesion is a bifurcation (side branch ≥ 1.5mm).

15. Treatment of the target lesion with the CSI coronary Diamondback Orbital Atherectomy System (OAS).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Heart Hospital	Little Rock	Arkansas	United States	72211
2	Glendale Adventist Medical Center	Glendale	California	United States	91206
3	Hartford Hospital	Hartford	Connecticut	United States	06102
4	MedStar Washington Hospital	Washington	District of Columbia	United States	20010
5	Clearwater Cardiovascular & Interventional Consultants	Clearwater	Florida	United States	33756
6	Mount Sinai Medical Center Heart Institute	Miami Beach	Florida	United States	33140
7	Cardiovascular Institute of NW Florida	Panama City	Florida	United States	32401
8	Georgia Regents Research Institute	Augusta	Georgia	United States	30912
9	University of Chicago Medical Center	Chicago	Illinois	United States	60637
10	Prairie Education & Research Cooperative	Springfield	Illinois	United States	62701
11	Indiana University	Indianapolis	Indiana	United States	46202
12	John Hopkins	Baltimore	Maryland	United States	21287
13	Tufts Medical Center	Boston	Massachusetts	United States	02111
14	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
15	Baystate Medical Center	Springfield	Massachusetts	United States	00119
16	McLaren Bay Regional	Bay City	Michigan	United States	48708
17	Beaumont Hospital	Royal Oak	Michigan	United States	48073
18	Boone Hospital	Columbia	Missouri	United States	65201
19	Saint Luke's	Kansas City	Missouri	United States	64111
20	Barnes Jewish Hospital	Saint Louis	Missouri	United States	63110
21	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
22	Jersey Shore Medical Center	Neptune	New Jersey	United States	07753
23	Mount Sinai New York	New York	New York	United States	10029
24	Duke University Medical Center	Durham	North Carolina	United States	27710
25	East Carolina University	Greenville	North Carolina	United States	27858
26	North Carolina Heart & Vascular Specialists	Raleigh	North Carolina	United States	27607
27	OhioHealth Research Institute	Columbus	Ohio	United States	43214
28	St. John Health System	Tulsa	Oklahoma	United States	74104
29	University Pittsburg MC - Hamot	Erie	Pennsylvania	United States	16507
30	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
31	University of Tennessee	Memphis	Tennessee	United States	38116
32	Houston Methodist Research Institute	Houston	Texas	United States	77030
33	Mission Research Institute	New Braunfels	Texas	United States	78130
34	Providence Health Center	Waco	Texas	United States	76712

Sponsors and Collaborators

• Cardiovascular Systems Inc

Investigators

• Principal Investigator: Samin K Sharma, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cardiovascular Systems Inc
• ClinicalTrials.gov Identifier: NCT01930214
• Other Study ID Numbers: CLN-0002-P
• First Posted: Aug 28, 2013
• Last Update Posted: Feb 11, 2020
• Last Verified: Jan 1, 2020

• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

Participant Flow

Recruitment Details	Enrollment was completed at 350 treated subjects.
Pre-assignment Detail	A subject was considered enrolled when a signed informed consent was in place, all inclusion/no exclusion criteria were met, and the study guidewire had crossed the target lesion.

Arm/Group Title	None/Mild Calcification	Moderate Calcification	Severe Calcification
Arm/Group Description	Presence of readily apparent radiopacities within the vascular wall at the site of the stenosis. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Presence of radiopacities only during the cardiac cycle before contrast injection with calcium extended partially into the target lesion. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location, total length of calcium (including segmented) must be at least 15mm and extend partially into the target lesion. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).
Period Title: Overall Study
STARTED	100	117	133
COMPLETED	80	96	108
NOT COMPLETED	20	21	25

Baseline Characteristics

Arm/Group Title	None/Mild Calcification	Moderate Calcification	Severe Calcification	Total
Arm/Group Description	Presence of readily apparent radiopacities within the vascular wall at the site of the stenosis. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Presence of radiopacities only during the cardiac cycle before contrast injection with calcium extended partially into the target lesion. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location, total length of calcium (including segmented) must be at least 15mm and extend partially into the target lesion. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Total of all reporting groups
Overall Participants	100	117	133	350
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.9 (10.3)	68.9 (10.6)	69.3 (9.2)	67.3 (10.4)
Sex: Female, Male (Count of Participants)
Female	29 29%	29 24.8%	34 25.6%	92 26.3%
Male	71 71%	88 75.2%	99 74.4%	258 73.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 6%	8 6.8%	5 3.8%	19 5.4%
Not Hispanic or Latino	94 94%	109 93.2%	128 96.2%	331 94.6%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	88 88%	98 83.8%	118 88.7%	304 86.9%
Black or African American	9 9%	13 11.1%	6 4.5%	28 8%
Asian	3 3%	5 4.3%	7 5.3%	15 4.3%
Native Hawaiian or Other Pacific Islander	1 1%	0 0%	0 0%	1 0.3%
Native American	0 0%	1 0.9%	0 0%	1 0.3%
Other	0 0%	1 0.9%	2 1.5%	3 0.9%
Region of Enrollment (participants) [Number]
United States	100 100%	117 100%	133 100%	350 100%

Outcome Measures

1. Primary Outcome

Title	MACE at 30 Days
Description	A Kaplan-Meier analysis was performed to determine the percent probability that a study participant experienced a major adverse cardiac event through 30 days. 30-day MACE is composed of: Cardiac death Myocardial Infarction (MI) - defined as a Creatine Kinase Myocardial-Band Isoenzyme (CK-MB) level greater than three (3) times the Upper Limit of Lab Normal (ULN) value with or without new pathologic Q wave Target Vessel Revascularization (TVR) - defined as a revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure
Time Frame	30 days post procedure

Outcome Measure Data

Analysis Population Description

Subjects were enrolled based on Investigator assessment of calcium; however, all analyses were performed by core lab assessed calcium to ensure consistent methodology. Of the 350 subjects enrolled in the study, 346 had sufficient angiography for core lab stratification (133 none/mild, 99 moderate, and 114 severe).

Arm/Group Title	None/Mild Calcification	Moderate Calcification	Severe Calcification
Arm/Group Description	Presence of readily apparent radiopacities within the vascular wall at the site of the stenosis as assessed by the angiographic core lab. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Presence of radiopacities only during the cardiac cycle before contrast injection with calcium extended partially into the target lesion as assessed by the angiographic core lab. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location, total length of calcium (including segmented) must be at least 15mm and extend partially into the target lesion as assessed by the angiographic core lab. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).
Measure Participants	133	99	114
Number (95% Confidence Interval) [Percent probability of MACE]	2.3	3.1	15

2. Secondary Outcome

Title	MACE at One (1) Year
Description	A Kaplan-Meier analysis was performed to determine the percent probability that a study participant experienced a major adverse cardiac event through 1 year. 1-year MACE is composed of: Cardiac death Myocardial Infarction (MI) - defined as a Creatine Kinase Myocardial-Band Isoenzyme (CK-MB) level greater than three (3) times the Upper Limit of Lab Normal (ULN) value with or without new pathologic Q wave Target Vessel Revascularization (TVR) - defined as a revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure
Time Frame	One (1) year post procedure

Outcome Measure Data

Analysis Population Description

Subjects were enrolled based on Investigator assessment of calcium; however, all analyses were performed by core lab assessed calcium to ensure consistent methodology. Of the 350 subjects enrolled in the study, 346 had sufficient angiography for core lab stratification (133 none/mild, 99 moderate, and 114 severe).

Arm/Group Title	None/Mild Calcification	Moderate Calcification	Severe Calcification
Arm/Group Description	Presence of readily apparent radiopacities within the vascular wall at the site of the stenosis as assessed by the angiographic core lab. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Presence of radiopacities only during the cardiac cycle before contrast injection with calcium extended partially into the target lesion as assessed by the angiographic core lab. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location, total length of calcium (including segmented) must be at least 15mm and extend partially into the target lesion as assessed by the angiographic core lab. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).
Measure Participants	133	99	114
Number (95% Confidence Interval) [Percent probability of MACE]	5.4	8.5	24.2

3. Secondary Outcome

Title	Procedural Success
Description	Procedural success is defined as success in facilitating stent delivery with a residual stenosis of <50% and without the occurrence of an in-hospital MACE.
Time Frame	Participants were followed from baseline procedure through hospital discharge, an expected average of 24 hours

Outcome Measure Data

Analysis Population Description

Subjects were enrolled based on Investigator assessment of calcium; however, all analyses were performed by core lab assessed calcium to ensure consistent methodology. Of the 350 subjects enrolled in the study, 346 had sufficient angiography for core lab stratification (133 none/mild, 99 moderate, and 114 severe).

Arm/Group Title	None/Mild Calcification	Moderate Calcification	Severe Calcification
Arm/Group Description	Presence of readily apparent radiopacities within the vascular wall at the site of the stenosis as assessed by the angiographic core lab. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Presence of radiopacities only during the cardiac cycle before contrast injection with calcium extended partially into the target lesion as assessed by the angiographic core lab. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location, total length of calcium (including segmented) must be at least 15mm and extend partially into the target lesion as assessed by the angiographic core lab. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).
Measure Participants	133	99	114
Number (95% Confidence Interval) [Percent of Procedures]	97.7	96	86.8

4. Secondary Outcome

Title	Lesion Success
Description	Lesion success is defined as success in facilitating stent delivery with a post-procedural result of <50% residual stenosis for a given lesion treated during the procedure without severe angiographic complications.
Time Frame	During the procedure

Outcome Measure Data

Analysis Population Description

Subjects were enrolled based on Investigator assessment of calcium; however, all analyses were performed by core lab assessed calcium to ensure consistent methodology. Of the 350 subjects enrolled in the study, 346 had sufficient angiography for core lab stratification (133 none/mild, 99 moderate, and 114 severe).

Arm/Group Title	None/Mild Calcification	Moderate Calcification	Severe Calcification
Arm/Group Description	Presence of readily apparent radiopacities within the vascular wall at the site of the stenosis as assessed by the angiographic core lab. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Presence of radiopacities only during the cardiac cycle before contrast injection with calcium extended partially into the target lesion as assessed by the angiographic core lab. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location, total length of calcium (including segmented) must be at least 15mm and extend partially into the target lesion as assessed by the angiographic core lab. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).
Measure Participants	133	99	114
Number [Percentage of Procedures]	94.7	88.9	83.3

Adverse Events

Time Frame	3 years
Adverse Event Reporting Description	AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Arm/Group Title	None/Mild Calcification		Moderate Calcification		Severe Calcification
Arm/Group Description	• Presence of readily apparent radiopacities within the vascular wall at the site of the stenosis. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).		• Presence of radiopacities only during the cardiac cycle before contrast injection with calcium extended partially into the target lesion. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).		• Presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location, total length of calcium (including segmented) must be at least 15mm and extend partially into the target lesion. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).
All Cause Mortality
	None/Mild Calcification		Moderate Calcification		Severe Calcification
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/134 (4.5%)		1/99 (1%)		7/117 (6%)
Serious Adverse Events
	None/Mild Calcification		Moderate Calcification		Severe Calcification
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	62/134 (46.3%)		47/99 (47.5%)		64/117 (54.7%)
Cardiac disorders
Acute MI, Q-wave	0/134 (0%)	0	0/99 (0%)	0	1/117 (0.9%)	1
Acute MI, non Q-wave	9/134 (6.7%)	9	6/99 (6.1%)	7	17/117 (14.5%)	19
Acute congestive heart failure	1/134 (0.7%)	1	0/99 (0%)	0	1/117 (0.9%)	1
Angina pectoris	17/134 (12.7%)	23	10/99 (10.1%)	14	12/117 (10.3%)	21
Arrhythmia, unspecified	1/134 (0.7%)	1	0/99 (0%)	0	0/117 (0%)	0
Atrial Fibrillation	5/134 (3.7%)	5	4/99 (4%)	5	5/117 (4.3%)	5
Atrioventricular block, III degree	0/134 (0%)	0	0/99 (0%)	0	1/117 (0.9%)	1
Cardiogenic shock	1/134 (0.7%)	1	0/99 (0%)	0	0/117 (0%)	0
Chest Pain	8/134 (6%)	8	3/99 (3%)	3	1/117 (0.9%)	1
Chest Pain, non ischemic	6/134 (4.5%)	6	3/99 (3%)	3	4/117 (3.4%)	4
Chronic CHF, or exacerbation	3/134 (2.2%)	4	3/99 (3%)	4	3/117 (2.6%)	3
Coronary artery restenosis	2/134 (1.5%)	3	1/99 (1%)	1	9/117 (7.7%)	13
Elevated CK-MB	0/134 (0%)	0	1/99 (1%)	1	1/117 (0.9%)	1
Elevated Troponin	1/134 (0.7%)	1	0/99 (0%)	0	1/117 (0.9%)	1
Elevated cardiac enzymes	0/134 (0%)	0	1/99 (1%)	1	0/117 (0%)	0
Other cardiovascular system related AE	2/134 (1.5%)	2	1/99 (1%)	1	1/117 (0.9%)	1
Sinus bradycardia	1/134 (0.7%)	1	0/99 (0%)	0	1/117 (0.9%)	2
Supraventricular tachycardia	1/134 (0.7%)	1	0/99 (0%)	0	0/117 (0%)	0
Ventricular fibrillation	0/134 (0%)	0	1/99 (1%)	1	0/117 (0%)	0
Cardiac Death	4/134 (3%)	4	0/99 (0%)	0	3/117 (2.6%)	3
General disorders
Allergic reaction to contrast dye	0/134 (0%)	0	1/99 (1%)	1	0/117 (0%)	0
Anemia	1/134 (0.7%)	1	0/99 (0%)	0	3/117 (2.6%)	3
Fever	0/134 (0%)	0	0/99 (0%)	0	1/117 (0.9%)	1
Infection, systemic	1/134 (0.7%)	1	0/99 (0%)	0	1/117 (0.9%)	1
Other index procedure related AE	0/134 (0%)	0	1/99 (1%)	1	0/117 (0%)	0
Other infection	2/134 (1.5%)	2	0/99 (0%)	0	0/117 (0%)	0
Other patient condition related AE	3/134 (2.2%)	3	2/99 (2%)	2	4/117 (3.4%)	4
Trauma	0/134 (0%)	0	1/99 (1%)	1	0/117 (0%)	0
Non-Cardiac Death	2/134 (1.5%)	2	1/99 (1%)	1	4/117 (3.4%)	4
Injury, poisoning and procedural complications
Abrupt or threatened closure of coronary artery	1/134 (0.7%)	1	0/99 (0%)	0	2/117 (1.7%)	2
Coronary artery vasospasm	0/134 (0%)	0	1/99 (1%)	1	0/117 (0%)	0
Coronary vessel dissection present (A-F)	12/134 (9%)	12	16/99 (16.2%)	16	25/117 (21.4%)	25
Coronary vessel perforation present	1/134 (0.7%)	1	0/99 (0%)	0	1/117 (0.9%)	1
Slow flow or no reflow phenomena	3/134 (2.2%)	3	0/99 (0%)	0	2/117 (1.7%)	2
Nervous system disorders
Cerebrovascular accident (CVA)	0/134 (0%)	0	1/99 (1%)	1	1/117 (0.9%)	1
Renal and urinary disorders
Renal insufficiency	2/134 (1.5%)	2	0/99 (0%)	0	0/117 (0%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnea/Shortness of breath	1/134 (0.7%)	1	1/99 (1%)	1	2/117 (1.7%)	2
Vascular disorders
Deep vein thrombosis (DVT)	1/134 (0.7%)	1	0/99 (0%)	0	1/117 (0.9%)	1
Hematoma at access site, not requiring intervention	3/134 (2.2%)	3	3/99 (3%)	3	2/117 (1.7%)	2
Hemorrhage, major, requiring transfusion	1/134 (0.7%)	1	0/99 (0%)	0	4/117 (3.4%)	4
Hemorrhage, minor, without transfusion	4/134 (3%)	4	3/99 (3%)	4	3/117 (2.6%)	3
Hypertension	0/134 (0%)	0	0/99 (0%)	0	1/117 (0.9%)	1
Hypotension	0/134 (0%)	0	1/99 (1%)	2	1/117 (0.9%)	1
Peripheral artery pseudoaneurysm	1/134 (0.7%)	1	1/99 (1%)	1	1/117 (0.9%)	1
Peripheral artery/vascular disease	2/134 (1.5%)	2	3/99 (3%)	4	0/117 (0%)	0
Peripheral vessel damage requiring surgical repair	0/134 (0%)	0	0/99 (0%)	0	1/117 (0.9%)	1
Other (Not Including Serious) Adverse Events
	None/Mild Calcification		Moderate Calcification		Severe Calcification
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/134 (0%)		0/99 (0%)		0/117 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Any previously unpublished information provided to the Investigators by the Sponsor is confidential and will remain the sole property of the Sponsor. The Investigator agrees to use this information only in accomplishing this study not use it for other purposes without the Sponsor's written consent. An Investigator can generate additional publication ideas based on the trial data. The Sponsor reserves the right to review the manuscript prior to submission in order to verify accuracy of the data