GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study (REDUCE PAS)
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ClinicalTrials.gov Identifier: NCT03821129 |
Recruitment Status :
Recruiting
First Posted : January 29, 2019
Last Update Posted : June 7, 2022
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Sponsor:
W.L.Gore & Associates
Information provided by (Responsible Party):
W.L.Gore & Associates
Tracking Information | |||||||
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First Submitted Date ICMJE | January 15, 2019 | ||||||
First Posted Date ICMJE | January 29, 2019 | ||||||
Last Update Posted Date | June 7, 2022 | ||||||
Actual Study Start Date ICMJE | July 25, 2019 | ||||||
Estimated Primary Completion Date | December 2026 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study | ||||||
Official Title ICMJE | GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study | ||||||
Brief Summary | This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting. | ||||||
Detailed Description | A maximum of 636 adult subjects will be enrolled at up to 40 U.S. centers. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 5 years post implant. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE | Device: PFO closure with GORE® CARDIOFORM Septal Occluder
PFO closure with GORE® CARDIOFORM Septal Occluder in patients with ischemic stroke
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Study Arms ICMJE | GORE® CARDIOFORM Septal Occluder
Single Arm Commercially available GORE® CARDIOFORM Septal Occluder
Intervention: Device: PFO closure with GORE® CARDIOFORM Septal Occluder
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
636 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | December 2029 | ||||||
Estimated Primary Completion Date | December 2026 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03821129 | ||||||
Other Study ID Numbers ICMJE | GSO 18-01 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | W.L.Gore & Associates | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | W.L.Gore & Associates | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | W.L.Gore & Associates | ||||||
Verification Date | June 2022 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |