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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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Study Status Completed
Application Number P040012 S034/ PAS001
Date Current Protocol Accepted 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.
Interim or Final Data Summary
Actual Number of Patients Enrolled 1203

Full Analysis Set population: 1196 subjects

Actual Number of Sites Enrolled 97
Patient Follow-up Rate 85.9 % at 2 years (based on the Full Analysis Set population)
Final Safety Findings Primary Endpoint

The study met the 12 month primary endpoint. The primary endpoint was the composite of death and Stroke (DS) within 30 days after the index procedure plus Ipsilateral Stroke rate between 31 days and 365 days. The primary endpoint rate for the overall patient population by Kaplan Meier (KM) analysis was 4.2% with upper one-sided 95% confidence interval (CI) of 5.15% which is less than the 8.4% performance goal (PG, p< 0.0001).

The freedom from death and stroke within 30 days and ipsilateral stroke between 31 days through 3 years in the overall population was 96.8% at 30 days, and 95.8%, 95.4% and 95.2% at 1, 2 and 3 years respectively.

Secondary Endpoints

Ipsilateral Stroke Rates

The freedom from ipsilateral stroke through 3 years by KM analysis was 97.5% at 30 days, 96.5% at 1 year, 96.1% at 2 years and 95.8% at 3 years. Majority of the ipsilateral strokes (63.8%, 30/47) occurred during the first 30 days and only 6 (12.8%) strokes occurred after 1 year.

Composite of Death and Stroke by Symptomatic Status

The composite of death and stroke rate at 30 days in the symptomatic group was 5.5% with upper one- sided 95% CI of 7.5% which is significantly less the 10.3% PG (p<0.0001). For the Asymptomatic group DS at 30 days was 2.3% with upper one-sided 95% CI of 3.19 % which is significantly less the 5.2 % PG (p<0.0001).

The freedom from death and stroke at 30 days and ipsilateral stroke at 1, 2 and 3 years was 92.9%, 92.6% and 91.9% respectively in the Symptomatic group and 96.9%, 96.5% and 96.4% respectively in the Asymptomatic group [Log Rank test p= 0.0020].

Composite of Death and Stroke by age

The death and stroke rate within 30 days for octogenarians (subjects = 80 years) was 3.4% and non- octogenarians (subjects < 80 years) was 3.2% [95% CI for the rate difference of -0.23 was -5.40% to 2.21%]. The freedom from death and stroke within 30 days plus ipsilateral stroke was 93.8% at 1, 2, and 3 years in octogenarians and 96.0%, 95.6%, and 95.3% at 1, 2 and 3 years respectively in non- octogenarian subjects [Log rank test, p =0.4486].

Clinically-driven target lesion revascularization (CD-TLR)

The freedom from clinically driven target lesion revascularization was 99.9% at 30 days, 99.3% at 1 year, 98.1% at 2 years and 97.5% at 3 years.

Study Strengths & Weaknesses The study met the primary endpoint and provided 2- year long term as well as available 3-year data. The 2 year follow-up compliance rate was adequate. This was a single-arm non randomized study that may not have the advantages of a randomized control trial. There were several protocol deviations reported and corrective actions were implemented where necessary.

Recommendations for Labeling Changes Labeling change is recommended to reflect the long term data from the post-approval study. The labeling change should include a new section on the label showing a summary of the post-approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoints, follow–up visits etc.), final results and study strengths and limitations of the PAS.

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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