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NCT04100135 · ClinicalTrials.gov registry record · NA
GORE® CARDIOFORM Septal Occluder Migraine Clinical Study
A NA study, sponsored by W.L.Gore & Associates.
- Terminated
- Registry status
- NA
- Development phase
- 7
- Enrollment target
NCT04100135: Clinical Trial NA study, sponsored by W.L.Gore & Associates.
NCT04100135 is a NA study that was terminated before completion, run by W.L.Gore & Associates. The registered enrollment target is 7 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04100135, a NA study, was terminated before completion, sponsored by W.L.Gore & Associates.
- TERMINATED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
Study Summary
Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief
Primary Outcome
Mean reduction in the number of migraine headache days per month from baseline to follow-up
Interventions
- DEVICE Actual device PFO closure
- DRUG Thienopyridine (clopidogrel or prasugrel)
- DEVICE Sham device PFO closure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2021-02-05 |
| Est. Completion | 2024-08-15 |
| Phase | NA |
Why NCT04100135 stopped before completion
NCT04100135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 3 interventions - of which Actual device PFO closure is the first listed.
NCT04100135 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04100135 about?
NCT04100135 is a clinical study titled "GORE® CARDIOFORM Septal Occluder Migraine Clinical Study". Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief
What is the current status of trial NCT04100135?
This trial is currently terminated. It is a NA study. The enrollment target is 7 participants. The study started on 2021-02-05. Estimated completion is 2024-08-15.
What interventions are being tested in trial NCT04100135?
The interventions under investigation include: Actual device PFO closure (DEVICE), Thienopyridine (clopidogrel or prasugrel) (DRUG), Sham device PFO closure (DEVICE).
Who is sponsoring clinical trial NCT04100135?
This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04100135's enrollment target sits among peer trials
7 1982nd of 2000 higher than 18 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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