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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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BSC Express PAS

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Study Status Completed
Application Number P060006 / PAS001
Date Current Protocol Accepted 12/11/2008
Study Name BSC Express PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The Renaissance study is a prospective, multi-center, single-arm study for use of the Express Renal stent in the treatment of ostial atherosclerotic lesions of the renal artery Single, de novo or restenotic from prior PTRA lesions were to be included in the clinical trial. The primary objective of the study was to demonstrate a superior 9-month binary restenosis rate of the Express Renal Premounted Stent System as compared to an Objective Performance Criterion representative of PTRA, for atherosclerotic lesions in the aortorenal ostium.
Study Population Description The Boston Scientific Express SD Renal Monorail Premounted Stent System is indicated as an adjunct to percutaneous transluminal renal angioplasty of a single de novo or restenotic atherosclerotic lesion (< 15 mm in length) of the renal artery, located within 5 mm of the opacified aortic lumen, with a reference vessel diameter of 4.0-7.0 mm to assist in the maintenance of vessel patency. The study population consists of the existing cohort of patients from the RENAISSANCE trial.
Sample Size 100 subjects with 117 lesions, the number of sites not reported
Data Collection The primary endpoint is binary in-stent restenosis rate of the Express Renal Stent at nine months, defined as the proportion of lesions with >50% diameter stenosis as determined by quantitative angiography.
Follow-up Visits and Length of Follow-up All subjects will be evaluated at 30 days, 4 months, 9 months, and annually for five years following the index procedure. The 30-day and 9-month visits must be office visits; the 4-month assessment is accomplished over the telephone. All subjects will undergo duplex ultrasound at 9 months and at 2 years after the index procedure. Office visits are required for the 1 -year and 2-year follow-ups. For the 3-, 4-, and 5-year annual follow-ups, office visits are strongly recommended; however, phone follow-ups at a minimum are required.
Interim or Final Data Summary
Interim Safety Information Study completed, see final results.
Actual Number of Patients Enrolled 100 patients
Actual Number of Sites Enrolled Not reported
Patient Follow-up Rate 82%
Final Safety Findings No serious, device-related events that were unanticipated in nature, frequency or severity occurred during the study. Furthermore, no new major adverse events occurred between the 4- and 5-year time points. Rates of target lesion revascularization, target vessel revascularization, and major adverse events have remained stable through 5 years of long-term follow-up with no unanticipated adverse device related events. No device- or procedure-related deaths or stent thromboses have been reported. No subjects progressed to require dialysis through 5 years of follow-up. The results from the study suggest that the Express SD Renal Stent System poses no serious concerns in terms of safety and effectiveness out to 5 year follow-up. As of October 23, 2009, no new revascularizations or significant embolic events have been reported between the 4-year and 5-year visits in any subject; 66 subjects completed the 5-year follow-up visit. Twenty-seven of 100 subjects (27%) had suffered a total of 49 reports of renal artery stenosis categorized as an SAE. The number of site-reported renal artery stenosis events requiring revascularization was 44; 26 of these 44 events in 16 subjects were adjudicated as target lesion revascularization. There have been a total of 19 reported deaths as of October 23, 2009. No deaths were adjudicated as either device- or index procedure-related. Based on the distribution of baseline co-morbidities, (e.g., congestive heart failure (CHF) rates, coronary artery disease (CAD) rates and the mean baseline age of the subjects enrolled in the RENAISSANCE study,) the sponsor concludes that the number of deaths through 5 years of follow-up is at an expected rate.
Study Strengths & Weaknesses Strengths: Overall follow-up was 81.5% of eligible subjects returning for 5-year follow-up. Weaknesses: There was no post approval hypotheses studied.
Recommendations for Labeling Changes There were no recommendations for changes to the labeling based on the results of the post-approval study.

BSC Express PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 06/11/2009 06/16/2009 Overdue/Received
Final Report 12/11/2009 12/09/2009 On Time

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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