|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P160003 / PAS001 |
| Study Name |
Extended Study of Premarket Cohort
|
| Device Name |
PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Continued follow-up PAS (PRO-Kinetic Energy Cobalt Chromium (CoCr) Coronary Stent System BIOHELIX-I Study) was a prospective, non-randomized, multi-center, Investigational Device Exemption (IDE) study designed to demonstrate the safety and effectiveness of BIOTRONIK’s PRO-Kinetic Energy Cobalt Chromium (CoCr) Coronary Stent System in subjects with atherosclerotic disease of native coronary arteries.
|
| Study Population |
All 329 subjects were in the device group
|
| Sample Size |
329 subjects total
|
| Key Study Endpoints |
Primary Endpoint: TVF rate at 9 months post-index procedure.
Secondary Endpoints: Secondary endpoints were not tested with formal hypotheses and only reported with descriptive statistics, including estimated rates and the associated exact, two-sided 95% confidence intervals.
TVF rate (primary endpoint at 9 months)
Individual components of the TVF rate (cardiac death, MI, ischemia-driven TVR)
Overall TVR rate
Target Lesion Failure (TLF) rate, including individual components of the TLF rate (cardiac death, MI, ischemia-driven Target Lesion Revascularization (TLR))
Overall TLR rate
Rate of all-cause mortality and all cause MI, including individual components
Stent thrombosis rate
Index procedure success
Device success
Lesion success
Angina pectoris classification
Rates for individual adverse event
|
| Follow-up Visits and Length of Follow-up |
36 months
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
329
|
| Actual Number of Sites Enrolled |
33
|
| Patient Follow-up Rate |
97.8%
|
| Final Safety Findings |
(Primary endpoint was TVF, a combined safety and effectiveness endpoint)
TVF at 9 months: 9.06% for ITT population.
TVF at 12 months: 10.76%
TVF at 24 months: 13.26%
TVF at 36 months: 17.61%
|
| Study Strengths & Weaknesses |
An independent Clinical Events Committee adjudicated all suspected cases of target vessel revascularization (TVR), myocardial infarction (MI), access site complications, bleeding events, vascular events as well as any deaths. The CEC determined if an event met the protocol definition of TVR or TLF (target lesion failure), and classified the relationship of an event to procedure or stent, as well as serious or non-serious in nature. An independent data safety monitoring board had oversight on safety aspects of the study and monitored the study for accumulating evidence regarding process of the study to meet its primary objective.
Specific groups of patients and lesion types were excluded from the study, including those with complex lesions, left main or coronary bypass graft lesions. In addition, patients with acute MI were not included. These exclusions may limit generalizability of the results. Secondary endpoints should be interpreted with caution as the sample size was calculated to provide adequate statistical power for the primary endpoint.
|
| Recommendations for Labeling Changes |
Yes
|
