Comparing biodegradable versus metal PFO occluders for people with migraine
A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine
We will test whether a biodegradable heart occluder works better than a metal occluder to reduce migraine symptoms in adults with a patent foramen ovale.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital Academic / other |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT06203873 on ClinicalTrials.gov |
What this trial studies
Adults with migraine and a confirmed right-to-left patent foramen ovale who have not adequately responded to preventive medications will be enrolled. Participants will undergo percutaneous closure using either a biodegradable occluder or a conventional metal occluder and will be followed to track migraine frequency, severity, and device-related safety outcomes. Imaging such as transesophageal echocardiography and transcranial Doppler will confirm PFO and device position, and follow-up visits will monitor migraine calendars and any complications. Outcomes will compare change in monthly migraine days and adverse events between the two device groups to see if the biodegradable device offers similar or superior migraine relief and safety.
Who should consider this trial
Good fit: Adults 18–65 with ICHD-3–diagnosed migraine for over one year, a confirmed PFO with right-to-left shunt, substantial daily-life impact, and inadequate response to at least three preventive migraine medications.
Not a fit: People whose migraines have a clear non-PFO cause, those with prior TIA or stroke, or patients contraindicated for antiplatelet/anticoagulation or PFO closure are unlikely to benefit from this procedure.
Why it matters
Potential benefit: If successful, a biodegradable occluder could lower monthly migraine days and reduce long-term device-related issues compared with metal devices.
How similar studies have performed: Prior observational studies and randomized trials of metal PFO occluders, including PRIMA and PREMIUM and pooled analyses of the Amplatzer device, have reported reductions in migraine days or benefits on secondary endpoints, while biodegradable occluders remain newer and less well tested for migraine outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-65 2. Diagnosed migraine by ICHD-3 3. History of migraine longer than 1 year, and symptoms severely disturbing daily life. 4. TCD/TTE/TEE diagnosed patent foramen ovale with right to left shunt 5. Willing to participant and agree to follow-ups 6. Received at least three different types of migraine preventive drugs, the responder rate of previous therapy did not receive 50%. Exclusion Criteria: 1. Migraine caused by other reason 2. Had TIA/stroke history 3. With contraindication or hypersensitive to anti-platelet or anticoagulation drugs. 4. With contraindication to PFO occlusion
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- Fuwai Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
- Fuwai Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xiangbin Pan, MD
- Email: panxiangbin@fuwaihospital.org
- Phone: 8688396666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.