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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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ODE Lead-BOLSTER Continued f/u Study


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General
Study Status Study Pending
Application Number P160024 / PAS001
Study Name ODE Lead-BOLSTER Continued f/u Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objective of this post approval study (BOLSTER Continued Follow-Up Study) is to evaluate the long term safety and effectiveness of the LifeStream Balloon Expandable Vascular Covered Stent for treatment of iliac arterial occlusive disease. This study is a prospective, single-armed, multi-center follow-up of the BPV-12-001 pivotal study (G140138).
Study Population Description The study population included symptomatic (Rutherford Category 2-4) patients with angiographic confirmation of either de novo or restenotic (non-stented) common and/or external iliac artery stenoses or occlusions, with reference vessel diameters between 4.5mm and 12.0mm in diameter and the target lesion = 100 mm in combined length (per side). Patients were included who presented with evidence of single, bilateral, or multiple de novo and/or restenotic (non-stented) lesion(s) in the native common and/or external iliac artery.
Sample Size All 148 remaining subjects (7 subjects have discontinued the study) of the 155 original study subjects enrolled from 24 investigational sites.
Data Collection Primary Endpoint:

Freedom from target lesion revascularization at 36 months.

Target lesion revascularization is defined as the first revascularization procedure (e.g., PTA, atherectomy, etc.) of the target lesion(s) following the index procedure as determined by an Independent Angiographic Core Lab (or CEC, as necessary).



Secondary Endpoints:

Freedom from target vessel revascularization (TVR) at 12, 24 and 36 months

Freedom from target lesion revascularization (TLR) at 12 and 24 months

Primary patency at 12, 24 and 36 months

Primary assisted patency at 12, 24 and 36 months

Secondary patency at 12, 24 and 36 months

Sustained clinical success at 12, 24 and 36 months

Quality of life at 12, 24 and 36 months

Serious adverse events at 12, 24 and 36 months

Follow-up Visits and Length of Follow-up 36 months


ODE Lead-BOLSTER Continued f/u Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/23/2017 10/24/2017 Overdue/Received
one year report 04/24/2018    
18 month report 10/23/2018    
two year report 04/24/2019    
three year report 04/23/2020    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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