A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biodegradable occluder, Metal occluder.
- Who it may be relevant to
- Registry conditions: PFO - Patent Foramen Ovale, Migraine, Migraine Headache, Migraine Headache, With or Without Aura. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Migraine is one of the most common chronic neurological disorders, posing a significant global public health concern. Patent Foramen Ovale (PFO) is the most common congenital heart anomaly in adults. Mechanisms linking PFO to migraine include cortical spreading depression, vascular active substance theory, impaired cerebral autoregulation, and genetic susceptibility. Understanding these mechanisms holds promise for overcoming challenges in the prevention and treatment of migraines in PFO patients. At least 11 observational studies, comprising 1,632 subjects, described the efficacy of PFO closure in cryptogenic stroke. Of these, 34% had migraines, and percutaneous PFO closure reportedly reduced migraine days by 81% (with a reduction of over 50% in monthly migraine days). Prospective randomized controlled trials (PRIMA and PREMIUM trials) assessing the Amplatzer® PFO Occluder showed significant benefits in most secondary endpoints, with a pooled analysis indicating its safety and effectiveness compared to medical therapy.While traditional metal PFO closure studies suggest symptom relief, reports also mention potential new-onset or worsened migraines post-closure. Proposed mechanisms include platelet activation, microthrombus formation, nickel allergy, and septal deformation or stretching inducing the release of migraine-related vascular active substances. However, these theories are closely tied to the presence of permanent metal implants. Addressing these concerns, the MemoSorb® biodegradable PFO Occluder system, approved by the National Medical Products Administration (NMPA) in September 2023, offers an innovative solution. Developed collaboratively by the National Biomedical Materials Engineering Technology Research Center, Professor Wang Yunbing\'s team, Professor Pan Xiangbin\'s team from Fuwai Hospital, Chinese Academy of Medical Sciences, and HeartTech Medical, this groundbreaking technology represents a shift from metal to degradable materials. The occluder serves as a temporary bridge post-implantation, gradually degrading with endothelialization, facilitating comprehensive self-repair. This intervention concept theoretically avoids the lifelong complications associated with traditional metal occluders, effectively reducing postoperative symptoms like migraines and dizziness. To assess and compare the treatment outcomes, especially in relieving migraines, a prospective, single-blind, randomized controlled study has been designed for patients with patent foramen ovale and migraine, comparing the novel biodegradable occluder with the metal occluder.
Interventions
- Device Biodegradable occluder
Patients assigned in this group will receive PFO occlusion with a biodegradable occluder. - Device Metal occluder
Patients assigned in this group will receive metal occluder for PFO occlusion
Primary outcome measures
- Reduced days per month at 12 month's follow-up [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Age 18-65
- Diagnosed migraine by ICHD-3
- History of migraine longer than 1 year, and symptoms severely disturbing daily life.
- TCD/TTE/TEE diagnosed patent foramen ovale with right to left shunt
- Willing to participant and agree to follow-ups
- Received at least three different types of migraine preventive drugs, the responder rate of previous therapy did not receive 50%.
Exclusion criteria
- Migraine caused by other reason
- Had TIA/stroke history
- With contraindication or hypersensitive to anti-platelet or anticoagulation drugs.
- With contraindication to PFO occlusion
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Fuwai Hospital — Beijing
- Fuwai Hospital — Beijing
Publications
- Li Z, Dong J, Dong J, Yan Y, Gao M, Fang F, Zhang F, Ouyang W, Wang S, Wang C, Pan X; BioMetal investigators. Comparison of biodegradable and metal occluders in patients with PFO and migraine: study design and rationale of BioMetal Trial. Trials. 2025 Aug 13;26(1):289. doi: 10.1186/s13063-025-09011-5. PMID 40804644
Identifiers
NCT: NCT06203873 · 2023-2229