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

January 3, 2024 updated by: Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Fuwai Hospital
        • Contact:
        • Principal Investigator:
          • Xiangbin Pan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biodegradable Occluder Cohort
Device: Biodegradable occluder
Patients assigned in this group will receive PFO occlusion with a biodegradable occluder.
Active Comparator: Metal Occluder Cohort
Device: Metal occluder
Patients assigned in this group will receive metal occluder for PFO occlusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduced days per month at 12 month's follow-up
Time Frame: 12 months
In the 12th month of follow-up, the average reduction in migraine days per month
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

January 3, 2024

First Submitted That Met QC Criteria

January 3, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-2229

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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