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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Extended Study of Premarket Cohort

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Study Status Completed
Application Number P160003 / PAS001
Study Name Extended Study of Premarket Cohort
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 Design Description 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 Description All 329 subjects were in the device group

Sample Size 329 subjects total

Data Collection 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

Extended Study of Premarket Cohort Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
one year report/Final report 02/14/2018 02/14/2018 On Time

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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