Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06203873
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-12
First Post:
2024-01-03
Brief Title:
A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine
Sponsor:
Chinese Academy of Medical Sciences Fuwai Hospital
Organization:
Chinese Academy of Medical Sciences Fuwai Hospital
Study Overview
Official Title:
A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BioMetal
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 1632 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 therapyWhile 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 Yunbing39s team Professor Pan Xiangbin39s 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
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 Yunbing39s team Professor Pan Xiangbin39s 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None