ArticleTrials2025
Comparison of biodegradable and metal occluders in patients with PFO and migraine: study design and rationale of BioMetal Trial.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06203873 (A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine), which is not on this map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
backgroundThe association between migraine and patent foramen ovale (PFO) has led to investigations into percutaneous PFO closure as a potential therapeutic avenue. While existing trials with metal occluders have shown promise in reducing migraine burden, concerns over long-term complications and the impact of metal devices on migraine exacerbation have prompted the development of biodegradable alternatives.
methodsThe Comparison of Biodegradable and Metal Occluders in Patients with PFO and Migraine (BioMetal) trial is a prospective, multicenter, single-blind, randomized controlled, superiority study comparing a biodegradable occluder with a nickel-titanium alloy occluder in PFO patients with medication-refractory migraine with aura (ClinicalTrials.gov Identifier: NCT06203873). A total of 400 participants will be enrolled, randomized 1:1 to receive either the biodegradable or metal devices, and followed up for 24 months post-randomization. The primary endpoint is the change in monthly migraine days at 12 months compared to baseline. DISCUSSION: The BioMetal trial aims to address the ongoing debate surrounding PFO closure for migraine relief by evaluating the efficacy and safety of biodegradable versus metal devices, with the goal of providing valuable insights into the optimal approach for PFO closure in PFO patients with medication-refractory migraine with aura. The potential implications extend beyond migraine management, highlighting the significance of biocompatible and sustainable materials in interventional cardiology. Completion of this study is anticipated to inform future clinical practice and guide therapeutic strategies in this complex condition.
trial registrationClinicalTrials.gov NCT06203873 ( https://clinicaltrials.gov/study/NCT06203873 ). Registered on January 3, 2024.
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