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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Application Number P040012 S034/ PAS001
Current Plan Approved 03/04/2016
Study Name OSB Lead-CANOPY Trial
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study is a prospective, multi-center, non-randomized, single arm.
Study Population Description Patients with neurological symptoms and > 70% stenosis of the common or internal carotid artery by ultrasound or > 50% stenosis of the common or internal carotid artery by angiogram OR patients without neurological symptoms and > 70% stenosis of the common or internal carotid artery by ultrasound or > 60% stenosis of the common or internal carotid artery by angiogram.
Sample Size The trial will enroll a minimum of 1,200 subjects (336 symptomatic and 864 asymptomatic subjects) at up to 350 sites in the United Sates.

The overall trial sample size was determined based on the secondary endpoint of peri- procedural DS by symptomatic status and its comparison with the respective PG (Symptomatic subjects: n= 336, accounting for 22 subject lost to follow-up; Asymptomatic subjects: n= 864 subjects, accounting for 58 subject lost to follow-up).

Data Collection Primary Endpoint: A composite rate of peri-procedural (within 30 days of the procedure) DS, plus ipsilateral stroke between day 31 and 1 year (365 days)

Secondary Endpoints

1. Composite of peri-procedural DS by symptomatic status

2. Ipsilateral stroke at 2 years

3. Composite of peri-procedural DS plus ipsilateral stroke at 1 and 2 years for octogenarians

4. Annual rate of clinically driven target lesion revascularization (TLR) through 2 years

Follow-up Visits and Length of Follow-up 2 years

Follow-up for all subjects will be performed at 24 hours post-procedure, 30 days, 1 year, and annually for a total of 2 years.

OSB Lead-CANOPY Trial Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 11/04/2011 08/30/2011 On Time
1 year report 05/05/2012 05/03/2012 On Time
18 month report 11/03/2012 10/31/2012 On Time
2 year report 05/05/2013 05/02/2013 On Time
3 year report 05/05/2014 04/21/2014 On Time
4 year report 05/05/2015 04/30/2015 On Time
Final Report 06/04/2016 06/01/2016 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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