NCT06615882

Mechanical Intracranial Artery DilAtation Using Stent-retriever for Cerebral Vasospasm

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Prospective exploratory study, single arm (off label), single center study 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.

Conditions

• Intracranial Vasospasm

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-01
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2024-09-27
• Last updated: 2024-09-27

Locations

1 site across 1 country: South Korea