FRED Retrospective Study of Intracranial Aneurysms Treatment

MicroVention

Status: Not yet enrolling

Conditions: Intracranial Aneurysm

Treatments: Device: Flow Re-Direction Endoluminal Device System(FRED)

Study type: Observational

Funder types: Industry

Identifiers

NCT06982781

CL1106094

Details and patient eligibility

About

To evaluate the long-term safety and efficacy of Flow Re-Direction Endoluminal Device System (FRED) in the treatment of intracranial aneurysms in the post-market environment

Full description

Study Objective: To evaluate the long-term safety and efficacy of Flow Re-Direction Endoluminal Device System (FRED) in the treatment of intracranial aneurysms in the post-market.

Study Design: Post-market, retrospective, multi-center, observational clinical study Study Population: Patient who has implanted at least one observational device in China mainland.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• People in China mainland who have been treated with FRED. The patients for whom clinical data are available

Exclusion criteria

• Patients who met the inclusion criteria at all time points were required to be included in the study. Therefore, no specific exclusion criteria were set.

Trial design