Coronary Arteries Disease
Conditions
Keywords
de novo coronary lesions, restenotic coronary lesions, coronary arteries
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.
Interventions
DEVICEPRO-Kinetic Energy Stent
Coronary artery stent implant
Sponsors
Biotronik, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
Countries
Colombia, Germany, Latvia, Netherlands, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pro-Kinetic Energy Stent PRO-Kinetic Energy Stent: Coronary artery stent implant | 329 |
| Total | 329 |
Baseline characteristics
| Characteristic | Pro-Kinetic Energy Stent |
|---|---|
| Age, Continuous | 69.0 Years STANDARD_DEVIATION 9.3 |
| Concomitant Medications Angiotensin II receptor blocker | 78 Participants |
| Concomitant Medications Anti-coagulant | 32 Participants |
| Concomitant Medications Antiotensin-converting-enzyme (ACE) inhibitor | 135 Participants |
| Concomitant Medications Antiplatelet - Clopidogrel | 79 Participants |
| Concomitant Medications Antiplatelet - Prasugrel | 9 Participants |
| Concomitant Medications Antiplatelet - Ticagrelor | 15 Participants |
| Concomitant Medications Aspirin | 260 Participants |
| Concomitant Medications Beta blocker | 203 Participants |
| Concomitant Medications Dual Antiplatelet Therapy (DAPT) | 96 Participants |
| Concomitant Medications Insulin | 37 Participants |
| Concomitant Medications Statins | 213 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 306 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Lesion Calcification Moderate | 58 Participants |
| Lesion Calcification None | 245 Participants |
| Lesion Calcification Severe | 26 Participants |
| Lesion Length | 13.7 mm STANDARD_DEVIATION 6 |
| Lesion Location Circumflex | 82 Participants |
| Lesion Location Left Anterior Descending (LAD) | 122 Participants |
| Lesion Location Right | 125 Participants |
| Medical History Current smoker | 60 Participants |
| Medical History Diabetes | 94 Participants |
| Medical History History of myocardial infarction (MI) | 67 Participants |
| Medical History Hyperlipidemia | 240 Participants |
| Medical History Hypertension | 276 Participants |
| Medical History Never smoked or not within last 5 years | 238 Participants |
| Medical History Prior coronary artery bypass graft (CABG) | 27 Participants |
| Medical History Prior percutaneous coronary revascularization | 100 Participants |
| Medical History Renal insufficiency | 8 Participants |
| Medical History Smoked within last 5 years | 31 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 305 Participants |
| Region of Enrollment Colombia | 1 Participants |
| Region of Enrollment Germany | 88 Participants |
| Region of Enrollment Latvia | 8 Participants |
| Region of Enrollment Netherlands | 17 Participants |
| Region of Enrollment United States | 215 Participants |
| Sex: Female, Male Female | 103 Participants |
| Sex: Female, Male Male | 226 Participants |
| Thrombolysis in Myocardial Infarction (TIMI) Flow 0 | 1 Participants |
| Thrombolysis in Myocardial Infarction (TIMI) Flow 1 | 6 Participants |
| Thrombolysis in Myocardial Infarction (TIMI) Flow 2 | 24 Participants |
| Thrombolysis in Myocardial Infarction (TIMI) Flow 3 | 298 Participants |
| Vessel Diameter Post-deployment target vessel MLD | 3.1 mm STANDARD_DEVIATION 0.5 |
| Vessel Diameter Pre-deployment target vessel MLD | 0.9 mm STANDARD_DEVIATION 0.4 |
| Vessel Diameter Pre-deployment target vessel reference diameter | 2.9 mm STANDARD_DEVIATION 0.5 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 27 / 311 |
| other Total, other adverse events | 118 / 329 |
| serious Total, serious adverse events | 202 / 329 |
Outcome results
Primary
Target Vessel Failure Rate
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pro-Kinetic Energy Stent | Target Vessel Failure Rate | Overall Target Vessel Failure Rate | 9.06 Percentage of participants |
| Pro-Kinetic Energy Stent | Target Vessel Failure Rate | Cardiac death | 0.95 Percentage of participants |
| Pro-Kinetic Energy Stent | Target Vessel Failure Rate | Myocardial infarction | 1.58 Percentage of participants |
| Pro-Kinetic Energy Stent | Target Vessel Failure Rate | Ischemia-driven target vessel revascularization | 7.26 Percentage of participants |
Secondary
All-cause Mortality and All-cause MI - Contribution of Individual Rates
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
Population: Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pro-Kinetic Energy Stent | All-cause Mortality and All-cause MI - Contribution of Individual Rates | All-cause mortality | 0.00 Percentage of participants |
| Pro-Kinetic Energy Stent | All-cause Mortality and All-cause MI - Contribution of Individual Rates | Cardiac mortality | 0.00 Percentage of participants |
| Pro-Kinetic Energy Stent | All-cause Mortality and All-cause MI - Contribution of Individual Rates | Non-cardiac mortality | 0.00 Percentage of participants |
| Pro-Kinetic Energy Stent | All-cause Mortality and All-cause MI - Contribution of Individual Rates | All-cause MI | 0.61 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | All-cause Mortality and All-cause MI - Contribution of Individual Rates | Cardiac mortality | 0.93 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | All-cause Mortality and All-cause MI - Contribution of Individual Rates | All-cause MI | 1.56 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | All-cause Mortality and All-cause MI - Contribution of Individual Rates | All-cause mortality | 1.87 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | All-cause Mortality and All-cause MI - Contribution of Individual Rates | Non-cardiac mortality | 0.93 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | All-cause Mortality and All-cause MI - Contribution of Individual Rates | All-cause MI | 1.58 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | All-cause Mortality and All-cause MI - Contribution of Individual Rates | Cardiac mortality | 0.95 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | All-cause Mortality and All-cause MI - Contribution of Individual Rates | Non-cardiac mortality | 1.58 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | All-cause Mortality and All-cause MI - Contribution of Individual Rates | All-cause mortality | 2.52 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | All-cause Mortality and All-cause MI - Contribution of Individual Rates | Cardiac mortality | 2.23 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | All-cause Mortality and All-cause MI - Contribution of Individual Rates | All-cause mortality | 5.73 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | All-cause Mortality and All-cause MI - Contribution of Individual Rates | All-cause MI | 1.91 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | All-cause Mortality and All-cause MI - Contribution of Individual Rates | Non-cardiac mortality | 3.50 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | All-cause Mortality and All-cause MI - Contribution of Individual Rates | All-cause mortality | 8.68 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | All-cause Mortality and All-cause MI - Contribution of Individual Rates | Cardiac mortality | 3.86 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | All-cause Mortality and All-cause MI - Contribution of Individual Rates | Non-cardiac mortality | 4.82 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | All-cause Mortality and All-cause MI - Contribution of Individual Rates | All-cause MI | 3.22 Percentage of participants |
Secondary
Angina Pectoris Classification
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
Population: Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pro-Kinetic Energy Stent | Angina Pectoris Classification | Total Unstable Angina | 12.5 Percentage of participants |
| Pro-Kinetic Energy Stent | Angina Pectoris Classification | Stable Angina - Class IV | 2.7 Percentage of participants |
| Pro-Kinetic Energy Stent | Angina Pectoris Classification | Unstable Angine Class IIB | 2.1 Percentage of participants |
| Pro-Kinetic Energy Stent | Angina Pectoris Classification | Unstable Angine Class IIC | 0.0 Percentage of participants |
| Pro-Kinetic Energy Stent | Angina Pectoris Classification | No Angina | 25.8 Percentage of participants |
| Pro-Kinetic Energy Stent | Angina Pectoris Classification | Unstable Angine Class IIIC | 0.0 Percentage of participants |
| Pro-Kinetic Energy Stent | Angina Pectoris Classification | Unstable Angine Class IIA | 2.7 Percentage of participants |
| Pro-Kinetic Energy Stent | Angina Pectoris Classification | Stable Angina - Class II | 23.4 Percentage of participants |
| Pro-Kinetic Energy Stent | Angina Pectoris Classification | Unstable Angine Class IC | 0.0 Percentage of participants |
| Pro-Kinetic Energy Stent | Angina Pectoris Classification | Unstable Angine Class IIIA | 1.2 Percentage of participants |
| Pro-Kinetic Energy Stent | Angina Pectoris Classification | Stable Angina - Class III | 17.6 Percentage of participants |
| Pro-Kinetic Energy Stent | Angina Pectoris Classification | Stable Angina - Class I | 17.9 Percentage of participants |
| Pro-Kinetic Energy Stent | Angina Pectoris Classification | Unstable Angine Class IB | 1.8 Percentage of participants |
| Pro-Kinetic Energy Stent | Angina Pectoris Classification | Total Stable Angina | 61.7 Percentage of participants |
| Pro-Kinetic Energy Stent | Angina Pectoris Classification | Unstable Angine Class IIIB | 3.0 Percentage of participants |
| Pro-Kinetic Energy Stent | Angina Pectoris Classification | Unstable Angine Class IA | 1.5 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Angina Pectoris Classification | Unstable Angine Class IIC | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Angina Pectoris Classification | Unstable Angine Class IIIC | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Angina Pectoris Classification | Unstable Angine Class IIA | 0.3 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Angina Pectoris Classification | Total Stable Angina | 2.4 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Angina Pectoris Classification | Total Unstable Angina | 0.3 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Angina Pectoris Classification | Stable Angina - Class IV | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Angina Pectoris Classification | Stable Angina - Class II | 0.6 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Angina Pectoris Classification | Stable Angina - Class I | 1.2 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Angina Pectoris Classification | Unstable Angine Class IA | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Angina Pectoris Classification | No Angina | 97.3 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Angina Pectoris Classification | Unstable Angine Class IB | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Angina Pectoris Classification | Unstable Angine Class IC | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Angina Pectoris Classification | Unstable Angine Class IIIA | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Angina Pectoris Classification | Stable Angina - Class III | 0.6 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Angina Pectoris Classification | Unstable Angine Class IIIB | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Angina Pectoris Classification | Unstable Angine Class IIB | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Angina Pectoris Classification | Stable Angina - Class III | 0.6 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Angina Pectoris Classification | Stable Angina - Class IV | 0.6 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Angina Pectoris Classification | Total Unstable Angina | 0.3 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Angina Pectoris Classification | Unstable Angine Class IA | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Angina Pectoris Classification | Unstable Angine Class IB | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Angina Pectoris Classification | Unstable Angine Class IIB | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Angina Pectoris Classification | Unstable Angine Class IIA | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Angina Pectoris Classification | Unstable Angine Class IIIB | 0.3 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Angina Pectoris Classification | Unstable Angine Class IIC | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Angina Pectoris Classification | Unstable Angine Class IIIA | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Angina Pectoris Classification | Stable Angina - Class I | 3.7 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Angina Pectoris Classification | No Angina | 93.9 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Angina Pectoris Classification | Total Stable Angina | 5.8 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Angina Pectoris Classification | Unstable Angine Class IC | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Angina Pectoris Classification | Stable Angina - Class II | 0.9 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Angina Pectoris Classification | Unstable Angine Class IIIC | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Angina Pectoris Classification | Unstable Angine Class IA | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Angina Pectoris Classification | Unstable Angine Class IB | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Angina Pectoris Classification | Stable Angina - Class III | 1.3 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Angina Pectoris Classification | Stable Angina - Class I | 6.2 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Angina Pectoris Classification | Unstable Angine Class IIIC | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Angina Pectoris Classification | Unstable Angine Class IIIA | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Angina Pectoris Classification | Unstable Angine Class IIC | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Angina Pectoris Classification | Unstable Angine Class IIIB | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Angina Pectoris Classification | Stable Angina - Class IV | 0.7 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Angina Pectoris Classification | Total Unstable Angina | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Angina Pectoris Classification | Unstable Angine Class IIB | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Angina Pectoris Classification | Unstable Angine Class IC | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Angina Pectoris Classification | Total Stable Angina | 11.1 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Angina Pectoris Classification | No Angina | 88.9 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Angina Pectoris Classification | Unstable Angine Class IIA | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Angina Pectoris Classification | Stable Angina - Class II | 2.9 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Total Unstable Angina | 0.3 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Unstable Angine Class IB | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Unstable Angine Class IIC | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Unstable Angine Class IIIB | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Unstable Angine Class IIIA | 0.3 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Stable Angina - Class II | 1.7 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Unstable Angine Class IA | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Unstable Angine Class IIIC | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Stable Angina - Class I | 2.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Unstable Angine Class IIB | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | No Angina | 94.7 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Total Stable Angina | 5.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Stable Angina - Class III | 1.3 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Stable Angina - Class IV | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Unstable Angine Class IIA | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Unstable Angine Class IC | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Month | Angina Pectoris Classification | Unstable Angine Class IC | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Month | Angina Pectoris Classification | Unstable Angine Class IIC | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Month | Angina Pectoris Classification | Unstable Angine Class IIA | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Month | Angina Pectoris Classification | No Angina | 95.3 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Month | Angina Pectoris Classification | Stable Angina - Class IV | 0.3 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Month | Angina Pectoris Classification | Unstable Angine Class IIIA | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Month | Angina Pectoris Classification | Total Unstable Angina | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Month | Angina Pectoris Classification | Unstable Angine Class IA | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Month | Angina Pectoris Classification | Unstable Angine Class IIIB | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Month | Angina Pectoris Classification | Unstable Angine Class IIIC | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Month | Angina Pectoris Classification | Stable Angina - Class II | 1.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Month | Angina Pectoris Classification | Unstable Angine Class IB | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Month | Angina Pectoris Classification | Stable Angina - Class I | 2.4 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Month | Angina Pectoris Classification | Total Stable Angina | 4.7 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Month | Angina Pectoris Classification | Stable Angina - Class III | 1.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Month | Angina Pectoris Classification | Unstable Angine Class IIB | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Stable Angina - Class II | 1.4 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Unstable Angine Class IIIA | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Unstable Angine Class IIIC | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Unstable Angine Class IIIB | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Total Unstable Angina | 0.7 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | No Angina | 94.3 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Unstable Angine Class IIA | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Unstable Angine Class IIC | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Stable Angina - Class I | 2.8 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Stable Angina - Class IV | 0.4 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Stable Angina - Class III | 0.4 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Unstable Angine Class IA | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Unstable Angine Class IC | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Unstable Angine Class IIB | 0.7 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Total Stable Angina | 4.9 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Angina Pectoris Classification | Unstable Angine Class IB | 0.0 Percentage of participants |
Secondary
Composite of All-cause Mortality and All-cause MI
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
Population: Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pro-Kinetic Energy Stent | Composite of All-cause Mortality and All-cause MI | 0.61 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Composite of All-cause Mortality and All-cause MI | 3.12 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Composite of All-cause Mortality and All-cause MI | 3.79 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Composite of All-cause Mortality and All-cause MI | 7.32 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Composite of All-cause Mortality and All-cause MI | 11.25 Percentage of participants |
Secondary
Device Success During the 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.
Time frame: Index procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pro-Kinetic Energy Stent | Device Success During the Index Procedure | 99.4 Percentage of participants |
Secondary
Index Procedure Success
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pro-Kinetic Energy Stent | Index Procedure Success | 98.8 Percentage of participants |
Secondary
Lesion Success During the 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.
Time frame: Index procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pro-Kinetic Energy Stent | Lesion Success During the Index Procedure | 99.4 Percentage of participants |
Secondary
Overall Target Lesion Failure Rate
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
Population: Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pro-Kinetic Energy Stent | Overall Target Lesion Failure Rate | 1.22 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Overall Target Lesion Failure Rate | 8.41 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Overall Target Lesion Failure Rate | 9.84 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Overall Target Lesion Failure Rate | 11.68 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Overall Target Lesion Failure Rate | 15.33 Percentage of participants |
Secondary
Overall Target Lesion Revascularization Rate
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
Population: Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pro-Kinetic Energy Stent | Overall Target Lesion Revascularization Rate | 0.61 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Overall Target Lesion Revascularization Rate | 7.23 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Overall Target Lesion Revascularization Rate | 8.65 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Overall Target Lesion Revascularization Rate | 9.24 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Overall Target Lesion Revascularization Rate | 10.37 Percentage of participants |
Secondary
Overall Target Vessel Revascularization Rate
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
Population: Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pro-Kinetic Energy Stent | Overall Target Vessel Revascularization Rate | 0.61 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Overall Target Vessel Revascularization Rate | 7.86 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Overall Target Vessel Revascularization Rate | 9.62 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Overall Target Vessel Revascularization Rate | 11.55 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Overall Target Vessel Revascularization Rate | 13.84 Percentage of participants |
Secondary
Stent Thrombosis Rate
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
Population: Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pro-Kinetic Energy Stent | Stent Thrombosis Rate | Probable stent thrombosis | 0.0 Percentage of participants |
| Pro-Kinetic Energy Stent | Stent Thrombosis Rate | Definite stent thrombosis | 0.3 Percentage of participants |
| Pro-Kinetic Energy Stent | Stent Thrombosis Rate | Total definite / probable stent thrombosis | 0.3 Percentage of participants |
| Pro-Kinetic Energy Stent | Stent Thrombosis Rate | Possible stent thrombosis | 0.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Stent Thrombosis Rate | Possible stent thrombosis | 0.9 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Stent Thrombosis Rate | Total definite / probable stent thrombosis | 1.3 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Stent Thrombosis Rate | Probable stent thrombosis | 0.3 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Stent Thrombosis Rate | Definite stent thrombosis | 0.9 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Stent Thrombosis Rate | Total definite / probable stent thrombosis | 1.3 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Stent Thrombosis Rate | Probable stent thrombosis | 0.3 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Stent Thrombosis Rate | Possible stent thrombosis | 1.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Stent Thrombosis Rate | Definite stent thrombosis | 1.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Stent Thrombosis Rate | Possible stent thrombosis | 1.6 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Stent Thrombosis Rate | Total definite / probable stent thrombosis | 1.3 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Stent Thrombosis Rate | Definite stent thrombosis | 1.0 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Stent Thrombosis Rate | Probable stent thrombosis | 0.3 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Stent Thrombosis Rate | Total definite / probable stent thrombosis | 1.7 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Stent Thrombosis Rate | Probable stent thrombosis | 0.3 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Stent Thrombosis Rate | Definite stent thrombosis | 1.4 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Stent Thrombosis Rate | Possible stent thrombosis | 2.7 Percentage of participants |
Secondary
Target Lesion Failure Rate - Contribution of Individual Event Types
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
Population: Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pro-Kinetic Energy Stent | Target Lesion Failure Rate - Contribution of Individual Event Types | Ischemia-driven target vessel revascularization | 0.61 Percentage of participants |
| Pro-Kinetic Energy Stent | Target Lesion Failure Rate - Contribution of Individual Event Types | Myocardial infarction | 0.61 Percentage of participants |
| Pro-Kinetic Energy Stent | Target Lesion Failure Rate - Contribution of Individual Event Types | Cardiac death | 0.00 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Target Lesion Failure Rate - Contribution of Individual Event Types | Myocardial infarction | 1.58 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Target Lesion Failure Rate - Contribution of Individual Event Types | Cardiac death | 0.95 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Target Lesion Failure Rate - Contribution of Individual Event Types | Ischemia-driven target vessel revascularization | 6.60 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Target Lesion Failure Rate - Contribution of Individual Event Types | Myocardial infarction | 1.61 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Target Lesion Failure Rate - Contribution of Individual Event Types | Cardiac death | 0.96 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Target Lesion Failure Rate - Contribution of Individual Event Types | Ischemia-driven target vessel revascularization | 8.04 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Target Lesion Failure Rate - Contribution of Individual Event Types | Cardiac death | 2.30 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Target Lesion Failure Rate - Contribution of Individual Event Types | Ischemia-driven target vessel revascularization | 8.61 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Target Lesion Failure Rate - Contribution of Individual Event Types | Myocardial infarction | 2.00 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Target Lesion Failure Rate - Contribution of Individual Event Types | Myocardial infarction | 3.50 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Target Lesion Failure Rate - Contribution of Individual Event Types | Cardiac death | 4.07 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Month | Target Lesion Failure Rate - Contribution of Individual Event Types | Ischemia-driven target vessel revascularization | 10.07 Percentage of participants |
Secondary
Target Vessel Failure Rate
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
Population: Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pro-Kinetic Energy Stent | Target Vessel Failure Rate | 1 Month | 1.22 Percentage of participants |
| Pro-Kinetic Energy Stent | Target Vessel Failure Rate | 12 Months | 10.76 Percentage of participants |
| Pro-Kinetic Energy Stent | Target Vessel Failure Rate | 24 Months | 13.26 Percentage of participants |
| Pro-Kinetic Energy Stent | Target Vessel Failure Rate | 36 Months | 17.61 Percentage of participants |
Secondary
Target Vessel Failure Rate - Contribution of Individual Event Types
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
Population: Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pro-Kinetic Energy Stent | Target Vessel Failure Rate - Contribution of Individual Event Types | Myocardial infarction | 0.61 Percentage of participants |
| Pro-Kinetic Energy Stent | Target Vessel Failure Rate - Contribution of Individual Event Types | Cardiac death | 0.00 Percentage of participants |
| Pro-Kinetic Energy Stent | Target Vessel Failure Rate - Contribution of Individual Event Types | Ischemia-driven target vessel revascularization | 0.61 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Target Vessel Failure Rate - Contribution of Individual Event Types | Myocardial infarction | 1.61 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Target Vessel Failure Rate - Contribution of Individual Event Types | Ischemia-driven target vessel revascularization | 8.97 Percentage of participants |
| PRO-Kinetic Energy Stent - 12 Months | Target Vessel Failure Rate - Contribution of Individual Event Types | Cardiac death | 0.96 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Target Vessel Failure Rate - Contribution of Individual Event Types | Myocardial infarction | 2.00 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Target Vessel Failure Rate - Contribution of Individual Event Types | Ischemia-driven target vessel revascularization | 10.23 Percentage of participants |
| PRO-Kinetic Energy Stent - 24 Months | Target Vessel Failure Rate - Contribution of Individual Event Types | Cardiac death | 2.30 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Target Vessel Failure Rate - Contribution of Individual Event Types | Ischemia-driven target vessel revascularization | 12.46 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Target Vessel Failure Rate - Contribution of Individual Event Types | Cardiac death | 4.07 Percentage of participants |
| PRO-Kinetic Energy Stent - 36 Months | Target Vessel Failure Rate - Contribution of Individual Event Types | Myocardial infarction | 3.50 Percentage of participants |