A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine

Migraine Clinical Trial

— BioMetal  

Official title:

A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06203873
• Other study ID #: 2023-2229
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: January 2025

Study information

• Verified date: January 2024
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Xiangbin Pan, MD
• Phone: 8688396666
• Email: panxiangbin[@]fuwaihospital.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: January 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Headache
• Migraine
• Migraine Disorders
• Migraine Headache
• Migraine Headache, With or Without Aura
• PFO - Patent Foramen Ovale

Intervention

Device:
• Biodegradable occluder
Patients assigned in this group will receive PFO occlusion with a biodegradable occluder.
• Metal occluder
Patients assigned in this group will receive metal occluder for PFO occlusion

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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