A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine
BioMetal
1 other identifier
interventional
400
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2024
CompletedFirst Posted
Study publicly available on registry
January 12, 2024
CompletedStudy Start
First participant enrolled
March 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedDecember 4, 2025
January 1, 2025
2 years
January 3, 2024
November 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Reduced days per month at 12 month's follow-up
In the 12th month of follow-up, the average reduction in migraine days per month
12 months
Study Arms (2)
Biodegradable Occluder Cohort
EXPERIMENTALMetal Occluder Cohort
ACTIVE COMPARATORInterventions
Patients assigned in this group will receive PFO occlusion with a biodegradable occluder.
Patients assigned in this group will receive metal occluder for PFO occlusion
Eligibility Criteria
You may qualify if:
- 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%.
You may not qualify if:
- Migraine caused by other reason
- Had TIA/stroke history
- With contraindication or hypersensitive to anti-platelet or anticoagulation drugs.
- With contraindication to PFO occlusion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Fuwai Hospital
Beijing, Beijing Municipality, 100037, China
Fuwai Hospital
Beijing, Beijing Municipality, 100037, China
Related Publications (1)
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: 40804644DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- The Vice President of Fuwai Hospital, Chinese Academy of Medical Sciences, and Director of the Structural Heart Disease Center.
Study Record Dates
First Submitted
January 3, 2024
First Posted
January 12, 2024
Study Start
March 1, 2024
Primary Completion
March 1, 2026
Study Completion
March 1, 2026
Last Updated
December 4, 2025
Record last verified: 2025-01