NCT06203873 A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine
| NCT ID | NCT06203873 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital |
| Condition | PFO - Patent Foramen Ovale |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2024-03-01 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06203873 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying PFO - Patent Foramen Ovale. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06203873 currently recruiting?
Yes, NCT06203873 is actively recruiting participants. Contact the research team at panxiangbin@fuwaihospital.org for enrollment information.
Where is the NCT06203873 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China.
Who is sponsoring the NCT06203873 clinical trial?
NCT06203873 is sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. The trial plans to enroll 400 participants.