Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06615882
NA

Mechanical Intracranial Artery DilAtation Using Stent-retriever for Cerebral Vasospasm

Sponsor: Yonsei University

View on ClinicalTrials.gov

Summary

Solitaire-x is a stent-retriever that is currently world-widely used, but is currently FDA-approved only as a revascularization device indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke. Its utility for mechanical endovascular dilatation for refractory intracranial vasospasm is an off-label indication. In this reason, we designed single-arm, prospective study, which aimed to report the safety and effectiveness of Solitaire-X in CV after subarachnoid Prospective exploratory study, single arm (off label), single center study

Official title: An Exploratory Study of Intra-arterial Mechanical Angioplasty Using a SOLITAIRE™ X Stent for Refractory and Recurrent Vasospasm Mechanical Intracranial Artery DilAtation Using Stent-retriever for Cerebral Vasospasm

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2024-09

Completion Date

2027-04

Last Updated

2024-09-27

Healthy Volunteers

No

Interventions

DEVICE

stent-angioplasty & nimodipine infusion (During the stent (Solitaire-X) -angioplasty, IA nimodipine was also infused)

I. Procedure \& Intervention 1. Assess the presence and degree of cerebral vasospasm of the target vessel through cerebral angiography before the procedure. 2. Solitaire-X stent types are selected 3. During the stent-angioplasty, IA nimodipine was also infused. 4. Retrieve Solitaire-X after maintaining deployment for 3 minutes. 5. Additional procedures are determined through immediate post-procedure and 15-minute delayed cerebral angiography.

Locations (1)

Yonsei university college of medicine

Seoul, South Korea