Comparison of biodegradable and metal occluders in patients with PFO and migraine: study design and rationale of BioMetal Trial.
Ziping Li, Jie Dong, Jing Dong...
https://pubmed.ncbi.nlm.nih.gov/40804644Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06203873
A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine
Led by Chinese Academy of Medical Sciences, Fuwai Hospital · Updated on 2025-12-04
400
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Migraine is a common chronic neurological condition linked to patent foramen ovale (PFO), a frequent congenital heart defect in adults. This research investigates the connection between PFO and migraines, focusing on the effects of closing the PFO to reduce migraine symptoms. Previous studies suggest that closing the PFO with metal devices can reduce migraine days but may also cause new or worsened migraines due to permanent metal implants. The study aims to compare outcomes using a new biodegradable PFO occluder versus a traditional metal occluder. Participants will be randomly assigned to receive either the innovative MemoSorb4 biodegradable occluder, which dissolves over time to avoid complications of metal implants, or the conventional metal occluder device. The biodegradable occluder acts as a temporary bridge that gradually degrades while the heart tissue repairs itself. This single-blind, controlled trial will evaluate the safety and effectiveness of these two devices in patients with both PFO and migraine. During the study, participants will be monitored for migraine frequency and severity, with the main outcome being the reduction in migraine days per month measured at 12 months after the procedure. Follow-ups will include clinical evaluations and diagnostic testing to assess device performance and migraine relief. The total study duration and safety monitoring will span at least one year post-implantation to compare long-term effects of the two occluder types.
CONDITIONS
Brief Title
A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years
- Diagnosed migraine according to ICHD-3 criteria
- History of migraine longer than 1 year with symptoms severely disturbing daily life
- Patent foramen ovale with right to left shunt confirmed by TCD, TTE, or TEE
- Willingness to participate and agree to follow-up visits
- Previous treatment with at least three different migraine preventive drugs without achieving 50% response rate
You will not qualify if you...
- Migraine caused by other reasons
- History of transient ischemic attack (TIA) or stroke
- Contraindication or hypersensitivity to anti-platelet or anticoagulation drugs
- Contraindication to patent foramen ovale occlusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - Single procedure
Participants receive either a biodegradable or metal occluder implanted to close the patent foramen ovale (PFO).
1 procedure visit (in-person)
Post-operative Follow-up
Duration - 12 months
Participants are monitored for recovery and outcomes after the occluder implantation.
Follow-up visits over 12 months
Trial Site Locations
Total: 2 locations
1
Fuwai Hospital
Beijing, Beijing Municipality, China, 100037
Not Yet Recruiting
2
Fuwai Hospital
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
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Research Team
X
Xiangbin Pan, MD
F
Fengwen Zhang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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