BIOHELIX-I Bare Metal Stent Study

• Sponsor: Biotronik, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01612767
• Collaborator: (none)
• Enrollment: 329
• Locations: 35
• Arm: 1
• Duration (Months): 60
• Patients Per Site: 9.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to demonstrate the safety and efficacy of the investigational BIOTRONIK PRO-Kinetic Energy stent in subjects with atherosclerotic disease of native coronary arteries.

Condition or Disease	Intervention/Treatment	Phase
Coronary Arteries Disease	Device: PRO-Kinetic Energy Stent	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 329 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Treatment of Coronary Artery Lesions Using the PRO-Kinetic Energy Cobalt-Chromium, Bare-Metal Stent
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Nov 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pro-Kinetic Energy Stent	Device: PRO-Kinetic Energy Stent; Coronary artery stent implant

Outcome Measures

Primary Outcome Measures

1. Target Vessel Failure Rate [9 months post-index procedure]

   The primary endpoint for the Pro-Kinetic Energy Stent is the target vessel failure rate at 9-months post-index procedure. Target vessel failure is defined as cardiac death, myocardial infarction and ischemia-driven target vessel revascularization.

Secondary Outcome Measures

1. Target Vessel Failure Rate [1, 12, 24 and 36 months post-index procedure]

   Evaluate the target vessel failure rate at 1, 12, 24, and 36 months post-index procedure. Target vessel failure is defined as cardiac death, myocardial infarction (MI) and ischemia-driven target vessel revascularization.

2. Target Vessel Failure Rate - Contribution of Individual Event Types [1, 12, 24 and 36 months post-index procedure]

   Contribution of each event type (cardiac death, myocardial infarction (MI) and ischemia-driven target vessel revascularization) to composite rate of target vessel failure.

3. Overall Target Vessel Revascularization Rate [1, 9, 12, 24 and 36 months post-index procedure]

   Evaluate the overall target vessel revascularization rate of the PRO-Kinetic Energy stent. The rate includes both ischemia-driven revascularization procedures of the target vessel, as well as revascularization procedures of the target vessel without prior clinical symptoms.

4. Overall Target Lesion Failure Rate [1, 9, 12, 24 and 36 months post-index procedure]

   Evaluate the target lesion failure rate of the PRO-Kinetic Energy stent. Target lesion failure includes cardiac death, MI, and ischemia-driven target lesion revascularization.

5. Target Lesion Failure Rate - Contribution of Individual Event Types [1, 9, 12, 24, and 36 months post-index procedure]

   The contribution of each individual event of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization to the overall rate of target lesion failure.

6. Overall Target Lesion Revascularization Rate [1, 9, 12, 24 and 36 months post-index procedure]

   Evaluate the overall target lesion revascularization rate associated with the PRO-Kinetic Energy stent. The overall target lesion revascularization rate includes both ischemia-driven revascularization procedures of the target lesion, as well as revascularization procedures of the target lesion without prior clinical symptoms.

7. Composite of All-cause Mortality and All-cause MI [1, 9, 12, 24, and 36 months post-index procedure]

   Characterize the overall safety of the PRO-Kinetic Energy stent by evaluating the composite rate of all-cause mortality and all-cause myocardial infarction.

8. All-cause Mortality and All-cause MI - Contribution of Individual Rates [1, 9, 12, 24, and 36 months post-index procedure]

   Contribution of the individual rates of mortality and myocardial infarction to the overall composite safety rate.

9. Stent Thrombosis Rate [1, 9, 12, 24 and 36 months post-index procedure]

   Evaluate the stent thrombosis rate associated with the PRO-Kinetic Energy stent. Stent thrombosis was classified according to both timing and evidence as outlined by the ARC definition of stent thrombosis. Participants were included in the evaluations at visit intervals if they had a visit at the specified interval or a thrombosis was reported at or before the visit.

10. Index Procedure Success [Index procedure]

    Evaluate the index procedure success associated with the implant of the PR-Kinetic Energy stent. procedure success is defined as the successful delivery and deployment of the investiational stent at the intended target lesion in combination with any adjunctive device (if applicable) to attain a final residual stenosis of < 30% by operator visual estimate without the occurrence of cardiac death, any MI (target vessel or non-target vessel) or TLR prior to hospital discharge.

11. Device Success During the Index Procedure [Index procedure]

    Evaluate the device success associated with the implant of the PRO-Kinetic Energy stent. Device success is defined as the successful delivery and deployment of the investigational stent at the intended target lesion in combination with standard post-dilation (if applicable) to attain a final residual stenosis of < 30% by operator visual estimate.

12. Lesion Success During the Index Procedure [Index procedure]

    Evaluate the lesion success associated with the implant of the PRO-Kinetic Energy stent. Lesion success is defined as the successful delivery and deployment of the investigational stent at the intended target lesion in combination with any adjunctive device (if applicable) to attain a final residual stenosis of < 30% by operator visual estimate.

13. Angina Pectoris Classification [Basline, Discharge, 1, 9, 12, 24 and 36 months post-index procedure]

    Evaluate the angina pectoris classification at each study visit. Stable angina pectoris was classified according to the Canadian Cardiovascular Society's System: Stable Angina - Class I: normal activity does not cause angina; Stable Angina - Class II: slight limitation of normal activity, moderate exertion may cause angina; Stable Angina - Class III: marked limitation of ordinary physical activity; Stable Angina - Class IV: discomfort with any physical activity and pain may be present at rest Unstable angina pectoris was classified according to the Braunwald System: Numeral I: newly onset severe or accelerated angina with no pain at rest; Numeral II: angina at rest within the preceding month but not the past 48 hours Numeral III: angina at rest within the preceding 48 hours; Letter A: develops in presence of conditions which intensify ischemia; Letter B: develops in the absence of extracardiac conditions; Letter C: develops within 2 weeks after an acute myocardial infarction

Eligibility Criteria

Criteria

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

Inclusion Criteria:

For a subject to be enrolled in the study and considered for the index procedure, the following initial inclusion criteria must be met:

• Age ≥ 18 years

• Willingness to comply with study follow-up requirements

• Candidate for a percutaneous coronary intervention (PCI) procedure

• Candidate for coronary artery bypass graft surgery

• Documented evidence of stable or unstable angina pectoris or positive functional ischemia study (e.g. exercise treadmill test, thallium stress test, SPECT, stress echocardiogram or cardiac CT) Stable angina pectoris is defined as a documented Canadian Cardiovascular Society Classification of I, II, III or IV Unstable angina pectoris is defined as a documented Braunwald Classification of B & C, I, II, III

• Written informed consent

For a subject to receive an investigational stent, the following procedure-related criteria must be met:

• De novo or restenotic lesion in a native coronary artery; restenotic lesions must have been previously treated with only standard percutaneous transluminal coronary angioplasty (PTCA) (treatment must be > 12 months prior to the index procedure)

• Target lesion must be in a major coronary artery (target vessel). The target vessel includes the entire territory of the left anterior descending artery, left circumflex artery or right coronary artery and any major side branch of the artery.

• A maximum of one target lesion and one non-target lesion may be treated per subject. The lesions must be located in separate coronary arteries, with treatment of the non-target lesion occurring first using commercially available therapy (with exception of brachytherapy).

• Lesions may be one solid lesion or a series of multiple, smaller lesions to be treated as one lesion

• Target lesion must be treatable with a single investigational stent; an additional stent may be used when treating a vessel dissection or another similar intra-procedure complication (use of investigational stent preferred)

• Angiographic evidence of ≥ 50% and < 100% stenosis (by operator visual estimate) with a TIMI flow > 1

• Target lesion length of ≤ 31 mm by operator visual estimate

• Target vessel reference diameter of 2.25 mm to 4.0 mm by operator visual estimate

Exclusion Criteria:

For a subject to be enrolled in the study and considered for the index procedure, the following initial exclusion criteria must not be present:

• Baseline LVEF of < 30%; LVEF may be measured and assessed by standard-of-care echocardiography procedures within 90 days of the index procedure or by a left ventriculogram prior to the index procedure (operator visual assessment).

• PCI in any vessel 30 days prior to the index procedure or planned for within 30 days after the index procedure

• Stroke or transient ischemic attack within the last 6 months prior to enrollment

• Intolerance to contrast agents that cannot be medically managed and/or intolerance to antiplatelet, anticoagulant or thrombolytic medications

• Refusal of blood transfusions

• Any other medical condition, that in the opinion of the investigator, poses an unacceptable risk for implant of a stent according to the study indications

• Pregnant, planning to become pregnant or nursing during the course of the study. Women of child-bearing potential must have a negative blood pregnancy (beta hCG) test. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test.

• Known allergy to L-605 CoCr alloy (cobalt, chromium, tungsten and nickel) or amorphous silicon carbide

• Life expectancy of less than one year

• Participation in any other clinical investigational device or drug study.

• Subjects may be concurrently enrolled in a post-market study, as long as the post-market study device, drug or protocol does not interfere with the investigational treatment or protocol of this study.

For a subject to receive an investigational stent the following procedure-related criteria must not be present:

• Documented diagnosis of an acute MI within 72 hours of the index procedure and an elevation of Troponin or creatine kinase-MB (CKMB) above the URL (CKMB measurement is not required if CK is normal) at the time of the index procedure (99th percentile of the individual investigative site's normal reference population)

• For subjects with stable angina and elevated Troponin, CKMB <99% URL is required

• ECG changes consistent with an acute MI within 72 hours of the index procedure. ECG changes consistent with an acute MI include:

1 mm ST segment elevation or depression in consecutive leads New left bundle branch block (LBBB) Development of pathological Q-waves in two contiguous leads of the electrocardiogram (ECG)

• Acute coronary syndrome with baseline Troponin > 99% URL

• INR ≥ 1.6

• Concomitant renal failure with serum creatinine level > 2.5 mg/dL

• Unresolved neutropenia (white blood cell count < 3,000 / µL), thrombocytopenia (platelet count < 100,000 / µL) or thrombocytosis (platelet count > 700,000 / µL)

• Unprotected left main coronary artery disease (CAD) (> 50% diameter stenosis by operator visual estimate)

• Target vessel has been treated with any PCI procedure (e.g. PTCA, stent, cutting balloon, atherectomy, etc.) within 12 months prior to the index procedure

• Target lesion has been treated with a stent, cutting balloon or atherectomy any time prior to the index procedure or has been treated with PTCA within 12 months prior to the index procedure

• Target vessel treated with brachytherapy anytime prior to index procedure

• Planned PCI in the target vessel within 9 months after the index procedure

• Target vessel has a non-target lesion with a > 50% stenosis that requires treatment during the index procedure

• Lesions preventing distal perfusion (TIMI flow 0 and 1) prior to wire crossing

• Target lesion is in the left main coronary artery or within 2 mm of the origin of the left anterior descending artery or left circumflex artery by operator visual estimate

• Target lesion is located within a saphenous vein graft or arterial graft

• Target lesion involves a bifurcation - lesion is located in a major coronary artery and involves a side branch with a diameter > 2 mm (by operator visual estimate)

• Presence of a complication following pre-dilatation of target lesion

• Presence of a complication following treatment of a non-target lesion (if applicable)

• Presence of a target vessel/lesion that has excessive tortuousity/angulation or is severely calcified preventing complete inflation of an angioplasty balloon

• Angiographic evidence of thrombus within the target lesion

• Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion

• Use of cutting balloons, atherectomy or ablative devices immediately prior to investigational stent placement

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Phoenix	Arizona	United States	85020
2		Concord	California	United States	94520
3		Mission Viejo	California	United States	92691
4		Danbury	Connecticut	United States	06810
5		New Haven	Connecticut	United States	06511
6		Washington	District of Columbia	United States	20010
7		Gainesville	Georgia	United States	30501
8		Indianapolis	Indiana	United States	46290
9		Iowa City	Iowa	United States	52242
10		Lafayette	Louisiana	United States	70506
11		Lewiston	Maine	United States	04240
12		Takoma Park	Maryland	United States	20912
13		Kansas City	Missouri	United States	64132
14		Springfield	Missouri	United States	65804
15		Newark	New Jersey	United States	07102
16		New York	New York	United States	10029
17		New York	New York	United States	10065
18		Poughkeepsie	New York	United States	12601
19		Gastonia	North Carolina	United States	28054
20		High Point	North Carolina	United States	27262
21		Columbus	Ohio	United States	43210
22		Portland	Oregon	United States	97239
23		Anderson	South Carolina	United States	29621
24		Greenville	South Carolina	United States	29605
25		Amarillo	Texas	United States	79106
26		McKinney	Texas	United States	75069
27		Tyler	Texas	United States	75701
28		Mechanicsville	Virginia	United States	23116
29		Medellin		Colombia
30		Bad Segeberg		Germany
31		Essen		Germany	D-45138
32		Ludwigshafen		Germany
33		Riga		Latvia
34		Amsterdam		Netherlands
35		Eindhoven		Netherlands	5623 EJ

Sponsors and Collaborators

• Biotronik, Inc.

Investigators

• Principal Investigator: Saurabh Gupta, MD, Oregon Health and Science University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biotronik, Inc.
• ClinicalTrials.gov Identifier: NCT01612767
• Other Study ID Numbers: G110147
• First Posted: Jun 6, 2012
• Last Update Posted: Sep 28, 2018
• Last Verified: Aug 1, 2018

• Keywords provided by Biotronik, Inc.: de novo coronary lesions; restenotic coronary lesions; coronary arteries
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

Participant Flow

Arm/Group Title	Pro-Kinetic Energy Stent
Arm/Group Description	PRO-Kinetic Energy Stent: Coronary artery stent implant
Period Title: Overall Study
STARTED	329
COMPLETED	287
NOT COMPLETED	42

Baseline Characteristics

Arm/Group Title	Pro-Kinetic Energy Stent
Arm/Group Description	PRO-Kinetic Energy Stent: Coronary artery stent implant
Overall Participants	329
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	69.0 (9.3)
Sex: Female, Male (Count of Participants)
Female	103 31.3%
Male	226 68.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	23 7%
Not Hispanic or Latino	306 93%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.3%
Asian	6 1.8%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	17 5.2%
White	305 92.7%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Number) [Number]
United States	215 65.3%
Germany	88 26.7%
Netherlands	17 5.2%
Latvia	8 2.4%
Colombia	1 0.3%
Medical History (Number) [Number]
Diabetes	94 28.6%
Hypertension	276 83.9%
Hyperlipidemia	240 72.9%
Current smoker	60 18.2%
Smoked within last 5 years	31 9.4%
Never smoked or not within last 5 years	238 72.3%
History of myocardial infarction (MI)	67 20.4%
Prior coronary artery bypass graft (CABG)	27 8.2%
Prior percutaneous coronary revascularization	100 30.4%
Renal insufficiency	8 2.4%
Concomitant Medications (Number) [Number]
Dual Antiplatelet Therapy (DAPT)	96 29.2%
Aspirin	260 79%
Antiplatelet - Clopidogrel	79 24%
Antiplatelet - Prasugrel	9 2.7%
Antiplatelet - Ticagrelor	15 4.6%
Antiotensin-converting-enzyme (ACE) inhibitor	135 41%
Angiotensin II receptor blocker	78 23.7%
Beta blocker	203 61.7%
Statins	213 64.7%
Insulin	37 11.2%
Anti-coagulant	32 9.7%
Lesion Location (Number) [Number]
Left Anterior Descending (LAD)	122 37.1%
Circumflex	82 24.9%
Right	125 38%
Lesion Length (mm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm]	13.7 (6.0)
Vessel Diameter (mm) [Mean (Standard Deviation) ]
Pre-deployment target vessel MLD	0.9 (0.4)
Pre-deployment target vessel reference diameter	2.9 (0.5)
Post-deployment target vessel MLD	3.1 (0.5)
Lesion Calcification (Number) [Number]
None	245 74.5%
Moderate	58 17.6%
Severe	26 7.9%
Thrombolysis in Myocardial Infarction (TIMI) Flow (Number) [Number]
0	1 0.3%
1	6 1.8%
2	24 7.3%
3	298 90.6%

Outcome Measures

1. Primary Outcome

Title	Target Vessel Failure Rate
Description	The primary endpoint for the Pro-Kinetic Energy Stent is the target vessel failure rate at 9-months post-index procedure. Target vessel failure is defined as cardiac death, myocardial infarction and ischemia-driven target vessel revascularization.
Time Frame	9 months post-index procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pro-Kinetic Energy Stent
Arm/Group Description	PRO-Kinetic Energy Stent: Coronary artery stent implant
Measure Participants	320
Overall Target Vessel Failure Rate	9.06 2.8%
Cardiac death	0.95 0.3%
Myocardial infarction	1.58 0.5%
Ischemia-driven target vessel revascularization	7.26 2.2%

2. Secondary Outcome

Title	Target Vessel Failure Rate
Description	Evaluate the target vessel failure rate at 1, 12, 24, and 36 months post-index procedure. Target vessel failure is defined as cardiac death, myocardial infarction (MI) and ischemia-driven target vessel revascularization.
Time Frame	1, 12, 24 and 36 months post-index procedure

Outcome Measure Data

Analysis Population Description

Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.

Arm/Group Title	PRO-Kinetic Energy Stent
Arm/Group Description	PRO-Kinetic Energy Stent: Coronary artery stent implant
Measure Participants	327
1 Month	1.22 0.4%
12 Months	10.76 3.3%
24 Months	13.26 4%
36 Months	17.61 5.4%

3. Secondary Outcome

Title	Target Vessel Failure Rate - Contribution of Individual Event Types
Description	Contribution of each event type (cardiac death, myocardial infarction (MI) and ischemia-driven target vessel revascularization) to composite rate of target vessel failure.
Time Frame	1, 12, 24 and 36 months post-index procedure

Outcome Measure Data

Analysis Population Description

Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.

Arm/Group Title	PRO-Kinetic Energy Stent - 1 Month	PRO-Kinetic Energy Stent - 12 Months	PRO-Kinetic Energy Stent - 24 Months	PRO-Kinetic Energy Stent - 36 Months
Arm/Group Description	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant
Measure Participants	327	316	309	301
Cardiac death	0.00 0%	0.96 NaN	2.30 NaN	4.07 NaN
Myocardial infarction	0.61 0.2%	1.61 NaN	2.00 NaN	3.50 NaN
Ischemia-driven target vessel revascularization	0.61 0.2%	8.97 NaN	10.23 NaN	12.46 NaN

4. Secondary Outcome

Title	Overall Target Vessel Revascularization Rate
Description	Evaluate the overall target vessel revascularization rate of the PRO-Kinetic Energy stent. The rate includes both ischemia-driven revascularization procedures of the target vessel, as well as revascularization procedures of the target vessel without prior clinical symptoms.
Time Frame	1, 9, 12, 24 and 36 months post-index procedure

Outcome Measure Data

Analysis Population Description

Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.

Arm/Group Title	Pro-Kinetic Energy Stent - 1 Month	PRO-Kinetic Energy Stent - 9 Month	PRO-Kinetic Energy Stent - 12 Month	PRO-Kinetic Energy Stent - 24 Month	PRO-Kinetic Energy Stent - 36 Month
Arm/Group Description	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant
Measure Participants	327	318	312	303	289
Number [Percentage of participants]	0.61 0.2%	7.86 NaN	9.62 NaN	11.55 NaN	13.84 NaN

5. Secondary Outcome

Title	Overall Target Lesion Failure Rate
Description	Evaluate the target lesion failure rate of the PRO-Kinetic Energy stent. Target lesion failure includes cardiac death, MI, and ischemia-driven target lesion revascularization.
Time Frame	1, 9, 12, 24 and 36 months post-index procedure

Outcome Measure Data

Analysis Population Description

Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.

Arm/Group Title	Pro-Kinetic Energy Stent - 1 Month	PRO-Kinetic Energy Stent - 9 Month	PRO-Kinetic Energy Stent - 12 Month	PRO-Kinetic Energy Stent - 24 Month	PRO-Kinetic Energy Stent - 36 Month
Arm/Group Description	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant
Measure Participants	327	321	315	308	300
Number [Percentage of participants]	1.22 0.4%	8.41 NaN	9.84 NaN	11.68 NaN	15.33 NaN

6. Secondary Outcome

Title	Target Lesion Failure Rate - Contribution of Individual Event Types
Description	The contribution of each individual event of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization to the overall rate of target lesion failure.
Time Frame	1, 9, 12, 24, and 36 months post-index procedure

Outcome Measure Data

Analysis Population Description

Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.

Arm/Group Title	Pro-Kinetic Energy Stent - 1 Month	PRO-Kinetic Energy Stent - 9 Month	Pro-Kinetic Energy Stent - 12 Month	Pro-Kinetic Energy Stent - 24 Month	Pro-Kinetic Energy Stent - 36 Month
Arm/Group Description	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant
Measure Participants	327	321	315	308	300
Cardiac death	0.00 0%	0.95 NaN	0.96 NaN	2.30 NaN	4.07 NaN
Myocardial infarction	0.61 0.2%	1.58 NaN	1.61 NaN	2.00 NaN	3.50 NaN
Ischemia-driven target vessel revascularization	0.61 0.2%	6.60 NaN	8.04 NaN	8.61 NaN	10.07 NaN

7. Secondary Outcome

Title	Overall Target Lesion Revascularization Rate
Description	Evaluate the overall target lesion revascularization rate associated with the PRO-Kinetic Energy stent. The overall target lesion revascularization rate includes both ischemia-driven revascularization procedures of the target lesion, as well as revascularization procedures of the target lesion without prior clinical symptoms.
Time Frame	1, 9, 12, 24 and 36 months post-index procedure

Outcome Measure Data

Analysis Population Description

Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.

Arm/Group Title	Pro-Kinetic Energy Stent - 1 Month	PRO-Kinetic Energy Stent - 9 Month	PRO-Kinetic Energy Stent - 12 Month	PRO-Kinetic Energy Stent -24 Month	PRO-Kinetic Energy Stent - 36 Month
Arm/Group Description	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant
Measure Participants	327	318	312	303	289
Number [Percentage of participants]	0.61 0.2%	7.23 NaN	8.65 NaN	9.24 NaN	10.37 NaN

8. Secondary Outcome

Title	Composite of All-cause Mortality and All-cause MI
Description	Characterize the overall safety of the PRO-Kinetic Energy stent by evaluating the composite rate of all-cause mortality and all-cause myocardial infarction.
Time Frame	1, 9, 12, 24, and 36 months post-index procedure

Outcome Measure Data

Analysis Population Description

Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.

Arm/Group Title	Pro-Kinetic Energy Stent - 1 Month	PRO-Kinetic Energy Stent - 9 Month	PRO-Kinetic Energy Stent - 12 Month	PRO-Kinetic Energy Stent - 24 Month	PRO-Kinetic Energy Stent - 36 Month
Arm/Group Description	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant
Measure Participants	326	321	317	314	311
Number [Percentage of participants]	0.61 0.2%	3.12 NaN	3.79 NaN	7.32 NaN	11.25 NaN

9. Secondary Outcome

Title	All-cause Mortality and All-cause MI - Contribution of Individual Rates
Description	Contribution of the individual rates of mortality and myocardial infarction to the overall composite safety rate.
Time Frame	1, 9, 12, 24, and 36 months post-index procedure

Outcome Measure Data

Analysis Population Description

Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.

Arm/Group Title	Pro-Kinetic Energy Stent - 1 Month	PRO-Kinetic Energy Stent - 9 Month	PRO-Kinetic Energy Stent - 12 Month	PRO-Kinetic Energy Stent - 24 Month	PRO-Kinetic Energy Stent - 36 Month
Arm/Group Description	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant
Measure Participants	326	321	317	314	311
All-cause mortality	0.00 0%	1.87 NaN	2.52 NaN	5.73 NaN	8.68 NaN
Cardiac mortality	0.00 0%	0.93 NaN	0.95 NaN	2.23 NaN	3.86 NaN
Non-cardiac mortality	0.00 0%	0.93 NaN	1.58 NaN	3.50 NaN	4.82 NaN
All-cause MI	0.61 0.2%	1.56 NaN	1.58 NaN	1.91 NaN	3.22 NaN

10. Secondary Outcome

Title	Stent Thrombosis Rate
Description	Evaluate the stent thrombosis rate associated with the PRO-Kinetic Energy stent. Stent thrombosis was classified according to both timing and evidence as outlined by the ARC definition of stent thrombosis. Participants were included in the evaluations at visit intervals if they had a visit at the specified interval or a thrombosis was reported at or before the visit.
Time Frame	1, 9, 12, 24 and 36 months post-index procedure

Outcome Measure Data

Analysis Population Description

Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.

Arm/Group Title	Pro-Kinetic Energy Stent - 1 Month	PRO-Kinetic Energy Stent - 9 Month	PRO-Kinetic Energy Stent - 12 Month	PRO-Kinetic Energy Stent - 24 Month	PRO-Kinetic Energy Stent - 36 Month
Arm/Group Description	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant
Measure Participants	327	319	313	305	293
Definite stent thrombosis	0.3 0.1%	0.9 NaN	1.0 NaN	1.0 NaN	1.4 NaN
Probable stent thrombosis	0.0 0%	0.3 NaN	0.3 NaN	0.3 NaN	0.3 NaN
Total definite / probable stent thrombosis	0.3 0.1%	1.3 NaN	1.3 NaN	1.3 NaN	1.7 NaN
Possible stent thrombosis	0.0 0%	0.9 NaN	1.0 NaN	1.6 NaN	2.7 NaN

11. Secondary Outcome

Title	Index Procedure Success
Description	Evaluate the index procedure success associated with the implant of the PR-Kinetic Energy stent. procedure success is defined as the successful delivery and deployment of the investiational stent at the intended target lesion in combination with any adjunctive device (if applicable) to attain a final residual stenosis of < 30% by operator visual estimate without the occurrence of cardiac death, any MI (target vessel or non-target vessel) or TLR prior to hospital discharge.
Time Frame	Index procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pro-Kinetic Energy Stent
Arm/Group Description	PRO-Kinetic Energy Stent: Coronary artery stent implant
Measure Participants	329
Number [Percentage of participants]	98.8 30%

12. Secondary Outcome

Title	Device Success During the Index Procedure
Description	Evaluate the device success associated with the implant of the PRO-Kinetic Energy stent. Device success is defined as the successful delivery and deployment of the investigational stent at the intended target lesion in combination with standard post-dilation (if applicable) to attain a final residual stenosis of < 30% by operator visual estimate.
Time Frame	Index procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pro-Kinetic Energy Stent
Arm/Group Description	PRO-Kinetic Energy Stent: Coronary artery stent implant
Measure Participants	329
Number [Percentage of participants]	99.4 30.2%

13. Secondary Outcome

Title	Lesion Success During the Index Procedure
Description	Evaluate the lesion success associated with the implant of the PRO-Kinetic Energy stent. Lesion success is defined as the successful delivery and deployment of the investigational stent at the intended target lesion in combination with any adjunctive device (if applicable) to attain a final residual stenosis of < 30% by operator visual estimate.
Time Frame	Index procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pro-Kinetic Energy Stent
Arm/Group Description	PRO-Kinetic Energy Stent: Coronary artery stent implant
Measure Participants	329
Number [Percentage of participants]	99.4 30.2%

14. Secondary Outcome

Title	Angina Pectoris Classification
Description	Evaluate the angina pectoris classification at each study visit. Stable angina pectoris was classified according to the Canadian Cardiovascular Society's System: Stable Angina - Class I: normal activity does not cause angina; Stable Angina - Class II: slight limitation of normal activity, moderate exertion may cause angina; Stable Angina - Class III: marked limitation of ordinary physical activity; Stable Angina - Class IV: discomfort with any physical activity and pain may be present at rest Unstable angina pectoris was classified according to the Braunwald System: Numeral I: newly onset severe or accelerated angina with no pain at rest; Numeral II: angina at rest within the preceding month but not the past 48 hours Numeral III: angina at rest within the preceding 48 hours; Letter A: develops in presence of conditions which intensify ischemia; Letter B: develops in the absence of extracardiac conditions; Letter C: develops within 2 weeks after an acute myocardial infarction
Time Frame	Basline, Discharge, 1, 9, 12, 24 and 36 months post-index procedure

Outcome Measure Data

Analysis Population Description

Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.

Arm/Group Title	Pro-Kinetic Energy Stent - Baseline	PRO-Kinetic Energy Stent - Discharge	PRO-Kinetic Energy Stent - 1 Month	PRO-Kinetic Energy Stent - 9 Month	PRO-Kinetic Energy Stent - 12 Month	PRO-Kinetic Energy Stent - 24 Month	PRO-Kinetic Energy Stent - 36 Month
Arm/Group Description	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant	PRO-Kinetic Energy Stent: Coronary artery stent implant
Measure Participants	329	329	326	307	303	296	283
No Angina	25.8 7.8%	97.3 NaN	93.9 NaN	88.9 NaN	94.7 NaN	95.3 NaN	94.3 NaN
Total Stable Angina	61.7 18.8%	2.4 NaN	5.8 NaN	11.1 NaN	5.0 NaN	4.7 NaN	4.9 NaN
Stable Angina - Class I	17.9 5.4%	1.2 NaN	3.7 NaN	6.2 NaN	2.0 NaN	2.4 NaN	2.8 NaN
Stable Angina - Class II	23.4 7.1%	0.6 NaN	0.9 NaN	2.9 NaN	1.7 NaN	1.0 NaN	1.4 NaN
Stable Angina - Class III	17.6 5.3%	0.6 NaN	0.6 NaN	1.3 NaN	1.3 NaN	1.0 NaN	0.4 NaN
Stable Angina - Class IV	2.7 0.8%	0.0 NaN	0.6 NaN	0.7 NaN	0.0 NaN	0.3 NaN	0.4 NaN
Total Unstable Angina	12.5 3.8%	0.3 NaN	0.3 NaN	0.0 NaN	0.3 NaN	0.0 NaN	0.7 NaN
Unstable Angine Class IA	1.5 0.5%	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN
Unstable Angine Class IB	1.8 0.5%	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN
Unstable Angine Class IC	0.0 0%	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN
Unstable Angine Class IIA	2.7 0.8%	0.3 NaN	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN
Unstable Angine Class IIB	2.1 0.6%	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN	0.7 NaN
Unstable Angine Class IIC	0.0 0%	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN
Unstable Angine Class IIIA	1.2 0.4%	0.0 NaN	0.0 NaN	0.0 NaN	0.3 NaN	0.0 NaN	0.0 NaN
Unstable Angine Class IIIB	3.0 0.9%	0.0 NaN	0.3 NaN	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN
Unstable Angine Class IIIC	0.0 0%	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN

Adverse Events

Time Frame	36 Months
Arm/Group Title	Pro-Kinetic Energy Stent
Arm/Group Description	PRO-Kinetic Energy Stent: Coronary artery stent implant
All Cause Mortality
	Pro-Kinetic Energy Stent
	Affected / at Risk (%)	# Events
Total	27/311 (8.7%)
Serious Adverse Events
	Pro-Kinetic Energy Stent
	Affected / at Risk (%)	# Events
Total	202/329 (61.4%)
Blood and lymphatic system disorders
Anemia	10/329 (3%)	12
Bleeding requiring treatment	2/329 (0.6%)	2
Coagulopathy	1/329 (0.3%)	1
Coumadin toxicity	1/329 (0.3%)	1
Hematoma - TAVI access site bleed	1/329 (0.3%)	1
Pancytopenia	2/329 (0.6%)	3
Supratherapeutic INR	3/329 (0.9%)	4
Hypovolemia	1/329 (0.3%)	1
Subtherapeutic INR	1/329 (0.3%)	1
Lymphadenopathy	1/329 (0.3%)	1
Cardiac disorders
Atrial arrhythmia	12/329 (3.6%)	13
Ventricular arrhythmia	3/329 (0.9%)	3
Unspecified arrhythmia	3/329 (0.9%)	3
Bradycardia	4/329 (1.2%)	4
Cardiac decompensation	3/329 (0.9%)	6
Cardiogenic shock	1/329 (0.3%)	1
Cardiopulmonary arrest	3/329 (0.9%)	3
Chest pain	33/329 (10%)	42
Congestive/worsening heart failure	15/329 (4.6%)	16
Diaphragmatic stimulation	1/329 (0.3%)	1
Dyspnea	9/329 (2.7%)	9
Edema	3/329 (0.9%)	3
Elective pacemaker/ICD implantation	3/329 (0.9%)	3
Elevated cardiac enzymes	2/329 (0.6%)	2
Heart block	1/329 (0.3%)	1
Hypertension	6/329 (1.8%)	6
Hypertensive urgency	2/329 (0.6%)	2
Ischemic cardiomyopathy	1/329 (0.3%)	1
Left ventricle penetration observed on LV gram	1/329 (0.3%)	1
Myocardial infarction	17/329 (5.2%)	20
Palpitations	3/329 (0.9%)	3
Peri-procedural myocardial infarction	1/329 (0.3%)	1
Planned PCI procedure	2/329 (0.6%)	2
Planned routine angiography	2/329 (0.6%)	2
Pleural effusion	4/329 (1.2%)	4
Stenosis/occlusion of target lesion within non-study stented segment	1/329 (0.3%)	1
Stenosis/restenosis of non-target lesion in target vessel	14/329 (4.3%)	19
Stenosis/restenosis of non-target vessel	27/329 (8.2%)	36
Syncope	3/329 (0.9%)	3
Valvular heart disease	5/329 (1.5%)	6
Atypical chest pain	4/329 (1.2%)	5
Angina	1/329 (0.3%)	2
Arrhythmia, Ventricular Extrasystole	1/329 (0.3%)	1
Ascites	1/329 (0.3%)	1
Fatigue	3/329 (0.9%)	3
Hypotension	3/329 (0.9%)	4
Hypertrophic cardiomyopathy	1/329 (0.3%)	1
Non-specific ST-T changes	1/329 (0.3%)	1
Pericardial effusion	1/329 (0.3%)	1
Premature ventricular contractions	1/329 (0.3%)	1
Pulmonary hypertension	1/329 (0.3%)	1
Stenosis - location unknown	1/329 (0.3%)	1
Vasospasm	1/329 (0.3%)	1
Worsening Coronary Artery Disease	3/329 (0.9%)	3
Pacemaker manfunction	1/329 (0.3%)	1
Ear and labyrinth disorders
Decreased hearing	1/329 (0.3%)	1
Endocrine disorders
Hypothyroidism	1/329 (0.3%)	1
Left adrenal mass	1/329 (0.3%)	1
Thyroid nodule	1/329 (0.3%)	1
Worsening diabetes	2/329 (0.6%)	2
Adrenal nodule	1/329 (0.3%)	1
Gout	1/329 (0.3%)	1
Hypoglycemia	1/329 (0.3%)	1
Eye disorders
Cataracts	2/329 (0.6%)	2
Eye irritation	1/329 (0.3%)	1
Herpes opthalmicus	1/329 (0.3%)	1
Low pupillary dilation	1/329 (0.3%)	1
Strabismus	1/329 (0.3%)	1
Gastrointestinal disorders
Abdominal bloating	1/329 (0.3%)	1
Abdominal pain	3/329 (0.9%)	3
Acute gangrenous cholecystitis	1/329 (0.3%)	1
Anastomotic disruption	1/329 (0.3%)	1
Atypical chest pain	1/329 (0.3%)	1
Candida esophagitis	1/329 (0.3%)	1
Cholecystitis	2/329 (0.6%)	2
Colitis	2/329 (0.6%)	4
Constipation	3/329 (0.9%)	3
Diverticulosis	2/329 (0.6%)	2
Elective bariatric surgery	1/329 (0.3%)	1
Epigastric pain	1/329 (0.3%)	1
Epiploic appendagitis	1/329 (0.3%)	1
Gastrointestinal bleed	9/329 (2.7%)	10
Gastritis	3/329 (0.9%)	3
Heartburn	1/329 (0.3%)	1
Intestinal ilius	1/329 (0.3%)	1
Intestinal obstruction	1/329 (0.3%)	1
Nausea and/or vomiting	3/329 (0.9%)	3
Pancreatitis	3/329 (0.9%)	4
Septic shock	1/329 (0.3%)	1
Small bowel obstruction	1/329 (0.3%)	1
Tubulovillous adenoma of ascending colon	1/329 (0.3%)	1
Dehydration	2/329 (0.6%)	2
Dysphagia	1/329 (0.3%)	1
Abdominal mass	1/329 (0.3%)	1
Abdominal distension	1/329 (0.3%)	1
Abdominal incisional hernia	1/329 (0.3%)	1
Diarrhea	1/329 (0.3%)	1
Gall bladder stone	1/329 (0.3%)	1
Gastroenteritis	1/329 (0.3%)	2
Gastroesophageal reflux disease	3/329 (0.9%)	3
Hiatal hernie	1/329 (0.3%)	1
Percutaneous endoscopic gastrostomy complication	1/329 (0.3%)	1
Rectal bleeding	1/329 (0.3%)	1
Unbilica hernia	1/329 (0.3%)	1
General disorders
Extracardiac pain	1/329 (0.3%)	1
Fever	1/329 (0.3%)	1
Headache	1/329 (0.3%)	1
Steroid toxicogenic reaction	1/329 (0.3%)	1
Vasovagal episode	1/329 (0.3%)	1
Dyspnea	2/329 (0.6%)	2
Metabolic acidosis	1/329 (0.3%)	1
Non-cardiac chest pain	1/329 (0.3%)	1
Syncope	2/329 (0.6%)	2
Immune system disorders
Allergic reaction to contrast media	1/329 (0.3%)	1
Allergic reaction with angioedema	1/329 (0.3%)	1
Infections and infestations
Bronchitis	7/329 (2.1%)	7
Cellulitis	4/329 (1.2%)	4
Fever	1/329 (0.3%)	1
Gastrointestinal viral infection	1/329 (0.3%)	1
HSV pneumonitis	1/329 (0.3%)	1
Leukocytosis	3/329 (0.9%)	3
MRSA	2/329 (0.6%)	2
Oral thrush	1/329 (0.3%)	1
Osteomyelitis	2/329 (0.6%)	2
Pneumonia	12/329 (3.6%)	17
Sepsis	3/329 (0.9%)	4
Surgical site dehiscence	1/329 (0.3%)	1
Urinary tract infection	11/329 (3.3%)	11
Wound	1/329 (0.3%)	1
Sinusitis	1/329 (0.3%)	1
Pancreas infection	1/329 (0.3%)	1
Metabolism and nutrition disorders
Hypercalcemia	1/329 (0.3%)	1
Hyperkalemia	2/329 (0.6%)	2
Hypernatremia	2/329 (0.6%)	2
Hypokalemia and/or hypomagnaesemia	3/329 (0.9%)	4
hyponatremia	1/329 (0.3%)	1
Musculoskeletal and connective tissue disorders
Back pain	2/329 (0.6%)	2
Calcar fracture	1/329 (0.3%)	1
Carpal tunnel syndrome	1/329 (0.3%)	1
Chest pain	1/329 (0.3%)	1
Genu varus deformity of right knee	1/329 (0.3%)	1
Muscle weakness	1/329 (0.3%)	1
Musculoskeletal injury/fall	11/329 (3.3%)	11
Musculoskeletal pain	5/329 (1.5%)	5
Vertebral fracture	2/329 (0.6%)	3
Worsening/degenerative osteoarthritis	3/329 (0.9%)	3
Knee arthooplasty	1/329 (0.3%)	1
Knee pain	1/329 (0.3%)	1
Left knee degenerative joint disease	1/329 (0.3%)	1
Osteoarthritis	1/329 (0.3%)	1
Right hand weakness	1/329 (0.3%)	1
Ulnar fracture	1/329 (0.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma	1/329 (0.3%)	1
Basal cell carcinoma	2/329 (0.6%)	2
Bladder cancer	1/329 (0.3%)	1
Brain cancer	2/329 (0.6%)	2
Hepatocellular carcinoma	1/329 (0.3%)	1
Lung cancer	3/329 (0.9%)	3
Melanoma in situ	1/329 (0.3%)	1
Relapsed myeloma	1/329 (0.3%)	1
Squamous cell carcinoma	3/329 (0.9%)	5
Bronchial carcinoma	1/329 (0.3%)	1
Cecum and liver cancer	1/329 (0.3%)	1
Colon adenocarcinoma	1/329 (0.3%)	1
Nervous system disorders
Dizziness	3/329 (0.9%)	3
Encephalopathy	6/329 (1.8%)	6
Lumbar radiculopathy	1/329 (0.3%)	1
Neuropathic pain	1/329 (0.3%)	1
Stroke	3/329 (0.9%)	4
Transient ischemic attack	3/329 (0.9%)	3
Seisure	1/329 (0.3%)	1
spinal stenosis	1/329 (0.3%)	1
Syndope	2/329 (0.6%)	2
Psychiatric disorders
Depression with suicidal ideations	1/329 (0.3%)	1
Major depression, chronic, recurrent with psychotic features	1/329 (0.3%)	1
Anxiety	1/329 (0.3%)	1
Renal and urinary disorders
Acute kidney injury	7/329 (2.1%)	8
Acute onset chronic renal injury	1/329 (0.3%)	1
Acute renal failure	7/329 (2.1%)	7
Contrast induced increased creatinine/acute renal insufficiency	1/329 (0.3%)	1
Hematuria	4/329 (1.2%)	4
Polyuria	1/329 (0.3%)	1
Prostatic bleeding	1/329 (0.3%)	1
Renal stone	1/329 (0.3%)	1
Urinary retention	2/329 (0.6%)	2
Benign prostatic hyperplasia	1/329 (0.3%)	1
Obstructive prostatism	1/329 (0.3%)	1
Acute renal injury	2/329 (0.6%)	2
Renal insufficiency	1/329 (0.3%)	1
Renal obstruction	1/329 (0.3%)	1
Respiratory, thoracic and mediastinal disorders
COPD exacerbation	10/329 (3%)	13
Cough	3/329 (0.9%)	3
Dyspnea	1/329 (0.3%)	1
End-stage lung disease	1/329 (0.3%)	1
Hypoxia	2/329 (0.6%)	2
Lung rheumatism	1/329 (0.3%)	1
Pulmonary embolism	3/329 (0.9%)	3
Respiratory arrest	1/329 (0.3%)	1
Respiratory distress	2/329 (0.6%)	2
Respiratory failure	5/329 (1.5%)	5
Acute respiratory failure	1/329 (0.3%)	1
Bronchitis	1/329 (0.3%)	1
Chronic Fibrotic Lung Disease	1/329 (0.3%)	1
Left pneumothorax	1/329 (0.3%)	1
Nasal obstruction	1/329 (0.3%)	1
Pleural effusion	1/329 (0.3%)	1
Pulmonary edema	1/329 (0.3%)	1
Skin and subcutaneous tissue disorders
Actinic keratosis/cheilitis	1/329 (0.3%)	2
Cicatricial changes to the left lower eyelid	1/329 (0.3%)	1
Contact dermatitis	1/329 (0.3%)	1
Non-healing wound	1/329 (0.3%)	1
Ulcer	3/329 (0.9%)	5
Surgical and medical procedures
Elevated troponin	1/329 (0.3%)	1
Hematoma	1/329 (0.3%)	1
Vascular disorders
Abdominal aortic aneurysm	3/329 (0.9%)	3
Carotid artery disease	1/329 (0.3%)	1
Deep vein thrombosis	3/329 (0.9%)	3
Femoral artery thrombosis	1/329 (0.3%)	1
Iliac artery stenosis / occlusion	2/329 (0.6%)	2
Peripheral ischemia	9/329 (2.7%)	13
Pseudoaneurysm	1/329 (0.3%)	1
Systemic emboli - spleen	1/329 (0.3%)	1
Vessel dissection or perforation	5/329 (1.5%)	5
Worsening of peripheral artery disease	1/329 (0.3%)	1
Worsening ulceration	1/329 (0.3%)	1
Stenosis or occlusion of target lesion within stent segment	27/329 (8.2%)	33
Stent thrombosis	5/329 (1.5%)	5
Stent thrombosis, ARC assessment	9/329 (2.7%)	9
Stent underexpansion	1/329 (0.3%)	1
Vessel dissection or perforation during stenting procedure	8/329 (2.4%)	8
Hematoma	2/329 (0.6%)	2
Peripheral vascular disease	1/329 (0.3%)	1
Post-surgical bleeding	1/329 (0.3%)	1
Saphenous vein insufficiency	1/329 (0.3%)	1
Possible PCI	1/329 (0.3%)	1
Other (Not Including Serious) Adverse Events
	Pro-Kinetic Energy Stent
	Affected / at Risk (%)	# Events
Total	118/329 (35.9%)
Cardiac disorders
Chest pain	59/329 (17.9%)	77
Dizziness	31/329 (9.4%)	35
Dyspnea	44/329 (13.4%)	55
Fatigue	22/329 (6.7%)	30
Hypertension	30/329 (9.1%)	35
Muskuloskeletal injury/fall	18/329 (5.5%)	29
Atrial Arrhyrhmia	17/329 (5.2%)	22
General disorders
Headache	25/329 (7.6%)	30
Musculoskeletal and connective tissue disorders
Back Pain	18/329 (5.5%)	19

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.