Comparing biodegradable versus metal PFO occluders for people with migraine
Official title: A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine
Run by Chinese Academy of Medical Sciences, Fuwai Hospital · NCT06203873 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital Academic / other |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Status | Recruiting |
| Started | March 1, 2024 |
| Main results expected | March 1, 2026 |
| Study ends | March 1, 2026 |
| Registry record updated | December 4, 2025 |
| Trial ID | NCT06203873 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Fuwai Hospital
Beijing, Beijing Municipality, China Recruiting -
Fuwai Hospital
Beijing, Beijing Municipality, China Not yet recruiting
Study contacts
- Study coordinator: Xiangbin Pan, MD
- Email: panxiangbin@fuwaihospital.org
- Phone: 8688396666
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Oral caffeine to reduce pain during acute migraine attacks
This test will see if a single 200 mg oral caffeine tablet taken during an acute migraine can reduce pain for adults with episodic or chronic migraine with or without aura.
-
Gepants for Acute Migraine in the Emergency Department
This study tests whether rimegepant or zavegepant given in the ED can relieve an acute migraine for adults.
-
Yoga-based Movements for Primary Headaches (YOURHEAD)
A yoga-based movement program is being tested to see if it can help reduce headaches and improve quality of life for adults with migraine and/or cluster headaches.
-
Analyzing CGRP Levels in Migraine Patients by Age and Sex
This study looks at the levels of a substance linked to migraines in people with migraines and healthy individuals to see how age and sex might affect treatment responses.
-
Remote electrical neuromodulation to test pain inhibition in migraine and fibromyalgia
We’re testing if the Nerivio wearable can boost the body’s natural pain-inhibition system (CPM) and reduce pain more than a sham device in adults with migraine or fibromyalgia.
-
Elismetrep (K-304) for acute treatment of migraine
This study tests whether a single dose of elismetrep can quickly lessen the pain of a migraine compared with placebo in adults 18 to 75.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.