Trials / Terminated
TerminatedNCT04100135
GORE® CARDIOFORM Septal Occluder Migraine Clinical Study
GORE® CARDIOFORM Septal Occluder Migraine Clinical Study: A Study to Evaluate the Safety and Efficacy of Transcatheter Closure of Patent Foramen Ovale for Relief of Migraine Headaches
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- W.L.Gore & Associates · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Actual device PFO closure | Actual PFO closure with the GORE® CARDIOFORM Septal Occluder |
| DRUG | Thienopyridine (clopidogrel or prasugrel) | Thienopyridine tablets (clopidogrel or prasugrel) administered for 6 months following device procedure |
| DEVICE | Sham device PFO closure | Sham (simulated) device PFO closure with result of no device implantation and no PFO closure |
Timeline
- Start date
- 2021-02-05
- Primary completion
- 2024-08-15
- Completion
- 2024-08-15
- First posted
- 2019-09-24
- Last updated
- 2024-12-18
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04100135. Inclusion in this directory is not an endorsement.