Last reviewed · How we verify
NCT04100135: RELIEF
GORE® CARDIOFORM Septal Occluder Migraine Clinical Study
NA trial testing Actual device PFO closure in Migraine in 7 participants. Terminated before completion.
15 August 2024
Quick facts
| Lead sponsor | W.L.Gore & Associates |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 7 |
| Start date | 5 February 2021 |
| Primary completion | 15 August 2024 |
| Estimated completion | 15 August 2024 |
| Sites | 15 locations across United States |
Drugs / interventions tested
- Actual device PFO closure
- Thienopyridine (clopidogrel or prasugrel) — full drug profile →
- Sham device PFO closure
Conditions studied
- Migraine — all drugs for Migraine →
- Patent Foramen Ovale — all drugs for Patent Foramen Ovale →
- PFO - Patent Foramen Ovale — all drugs for PFO - Patent Foramen Ovale →
Sponsor
W.L.Gore & Associates — full company profile →
Who can join
Adults 18 to 55, any sex, with Migraine or Patent Foramen Ovale. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Patent Foramen Ovale Closure: State of the Art.
Giblett JP, Williams LK, Kyranis S, Shapiro LM, et al · · 2020 · cited 35× · PMID 33318751 · DOI 10.15420/icr.2019.27 -
A New Syndrome of Patent Foramen Ovale Inducing Vasospastic Angina and Migraine.
Ravi D, Parikh RV, Aboulhosn J, Tobis JM. · · 2023 · cited 6× · PMID 38204551 · DOI 10.1016/j.jaccas.2023.102132 -
Efficacy and safety of patent foramen ovale closure for mitigating migraine: a systematic review and meta-analysis of randomized trials and observational studies.
Silalahi TDA, Hariyanto TI. · · 2024 · cited 5× · PMID 39371639 · DOI 10.1177/17562864241271033 -
Patent Foramen Ovale Closure in Special Clinical Situations: More Questions Than Answers?
Apostolos A, Alexiou P, Papanikolaou A, Trantalis G, et al · · 2024
Verify or expand the search:
- PubMed search for NCT04100135
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Migraine
Currently open trials in the same condition.
- NCT07419607 — MIGRAFIT: Evaluating a Group Therapy Program Combining Physical Activity, Progressive Muscle Relaxation and Psychoeducat · NA · recruiting
- NCT07487701 — Migraine Prevention With the Remote Electrical Neuromodulation (REN) Wearable: A Real-world Evidence Study · NA · active not recruiting
- NCT07343427 — Impact of GON PRF on Central Sensitization in Migraine Patients · NA · active not recruiting
- NCT07336056 — Nerivio Efficacy Under High-Frequency Use · Phase 4 · active not recruiting
- NCT07385755 — Desvenlafaxine for Preventive Treatment of Frequent Migraines · NA · active not recruiting
Other W.L.Gore & Associates trials
Trials by the same sponsor.
- NCT07147569 — TAMBE Japan Post-Marketing Surveillance · recruiting
- NCT06827990 — GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections · NA · recruiting
- NCT06872905 — Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular · recruiting
- NCT06578741 — GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study · NA · enrolling by invitation
- NCT06174376 — Clinical Outcomes of the Gore Synthetic Cornea Device · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04100135 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by W.L.Gore & Associates
- Last refreshed: 18 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04100135.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing