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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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Continued f/u of IDE Cohort


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General
Study Status Progress Adequate
Application Number P050006 S060/ PAS001
Study Name Continued f/u of IDE Cohort
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The REDUCE study is a prospective, randomized (2:1), open-label, multi-center clinical study. The current post approval study is a continued follow-up of the premarket cohorts out to 5 years.



Study Population Description Enrollment in the REDUCE study was limited to patients who met the following key inclusion criteria:

Patient greater than or equal to 18 years and <60 years of age

Cryptogenic, ischemic stroke of presumed embolic etiology, verified by a neurologist within 180 days prior to randomization, meeting either criteria:

Ischemic stroke clinical symptoms persisting =24 hours; or

Clinical symptoms persisting <24 hours and MRI evidence of infarction.

For MRI-incompatible patients (i.e., patients that are claustrophobic and/or have implants that are contraindicated for MR), CT scan accepted

PFO, confirmed by TEE with bubble study demonstrating spontaneous right-to-left shunting or right-to-left shunting during Valsalva maneuver

Absence of an identifiable source of thromboembolism in the systemic arterial circulation.

Vascular imaging that rules out other potential sources of cerebral thromboembolism (e.g., dissection of the aorta or neck vessels, carotid stenosis >50% and/or presence of ulcerated plaques, or intracranial stenosis >50%)

No evidence of hypercoagulable state, which requires anticoagulation therapy, based on the evaluation of, at a minimum:

Platelet count, Prothrombin Time (PT) or INR, aPTT, and antiphospholipid antibodies.

A history of thromboembolic events in first degree family members obtained for all patients. For patients who had a first-degree family member with such an event prior to age 55, or whose family history is unknown, the following additional tests were required and must be interpreted as normal: Factor V Leiden mutation, Prothrombin Gene G20210A mutation, protein C, protein S, and Antithrombin III.

Testing for prothrombotic disorders may be performed at the discretion of the treating physicians but was not required.

Patients were randomized 2:1 to the test or the control group. Device group subjects were treated with antiplatelet medical management and PFO closure with the GORE® CARDIOFORM Septal Occluder or GORE® HELEX® Septal Occluder (prior device generation approved under P050006). Control group subjects were treated with antiplatelet medical management alone. Subjects at each site were treated with the same antiplatelet therapy regardless of study arm. Investigators chose one of the following options: aspirin alone (75-325 mg once daily), combination aspirin (50-100 mg) and dipyridamole (225-400 mg), or clopidogrel (75 mg once daily). Other combinations or the use of anticoagulants was not permitted.

Sample Size In the PMA study, 664 patients enrolled. There were 441 subjects randomized to the test group and 223 subjects randomized to the control group. The current post approval study is a continued follow-up of the premarket cohorts out to 5 years.
Data Collection Effectiveness Endpoints

With regards to effectiveness, there were two co-primary endpoints for the study. The first was freedom from recurrent clinical ischemic stroke through at least 24 months. A recurrent ischemic stroke event was defined as the first occurrence of one of the following:

• Clinical finding of ischemic stroke that may be associated with MRI evidence of a new relevant brain infarction. An ischemic stroke was defined as a neurological deficit, presumed due to ischemia, persisting longer than 24 hours or until death.

• Transient neurological deficit, presumed due to ischemia, persisting less than 24 hours that also had MRI evidence of a new relevant brain infarction.



The second co-primary endpoint was the incidence of subjects with new brain infarction or clinical findings of ischemic stroke from screening through 24 months or last follow-up visit, whichever occurred first. New brain infarction was defined as the composite of clinical ischemic stroke (defined above) or radiographically-detected but clinically covert brain infarct. Any subject with at least one new T2 hyperintense MRI lesion with diameter = 3 mm between the screening MRI and the 24-month MRI, or clinical findings of ischemic stroke through 24 months, and confirmed by the blinded MRI Core Lab or CEC, was classified as having a new brain infarction.



Secondary effectiveness endpoints consisted of an assessment of PFO closure in the device group subjects by transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE).



With regards to safety, endpoints included the proportion of subjects who experienced adverse events (AEs) that are determined to be related to device, procedure, and/or antiplatelet medical management. The safety assessment included specific adverse events and groups of adverse events such as all-cause adverse events, device-related events, procedure-related events, antiplatelet medical therapy-related events, and any serious adverse events.



Follow-up Visits and Length of Follow-up 5 years


Continued f/u of IDE Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/28/2018 09/26/2018 On Time
one year report 03/30/2019 03/15/2019 On Time
18 month report 09/28/2019 09/04/2019 On Time
two year report 03/29/2020    
three year report 03/29/2021    


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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