NCT06047964

SeQuent ® Please CIS for the Treatment of INtracranial Atherosclerotic Stenosis

A Prospective, Multicenter, Clinical Trial to Evaluate the Safety and Effectiveness of the Intracranial Paclitaxel Drug-eluting Balloon Catheters (SeQuent® Please CIS) in the Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis and Restenosis After Interventional Therapy

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 281 (actual)
• Sponsor: B. Braun Medical International Trading Company Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is aiming to evaluate the safety and efficacy of SeQuent® Please CIS in the endovascular treatment of symptomatic intracranial atherosclerotic stenosis and restenosis after interventional therapy.

Detailed description

This study includes 2 sub-studies, sub-study A and sub-study B, namely. Sub-study A is a prospective, multicenter, randomized controlled, superior clinical trial to evaluate the safety and effectiveness of paclitaxel drug-releasing intracranial balloon catheter (SeQuent® Please CIS) in the treatment of symptomatic intracranial atherosclerotic stenosis. Sub-study B is a prospective, multicenter, single-arm clinical trial designed to evaluate the safety and efficacy of paclitaxel drug-releasing intracranial balloon catheter (SeQuent® Please CIS) for the treatment of restenosis following interventional treatment for symptomatic intracranial atherosclerotic stenosis. A total of 277 subjects are expected to be enrolled, including 252 subjects in sub-study A and 25 subjects in sub-study B. Subjects enrolled in sub-study A will be randomized into the study arm and the control arm with the ratio of 1:1. The study arm will be treated with SeQuent® Please CIS (paclitaxel drug-releasing intracranial balloon catheter), while the control arm will be treated with intracranial PTA balloon catheter. Subjects enrolled in sub-study A will all be treated with SeQuent®, Please CIS. All subjects will be followed up till 12 month post procedure.

Conditions

• Stroke
• Intracranial Atherosclerotic Stenosis

Interventions

Type	Name	Description
DEVICE	DCB	Intracranial paclitaxel drug-eluting balloon catheters (SeQuent® Please CIS)
DEVICE	POBA	Intracranial PTA balloon catheter

Timeline

• Start date: 2023-03-23
• Primary completion: 2024-09-29
• Completion: 2025-01-23
• First posted: 2023-09-21
• Last updated: 2024-10-21

Locations

9 sites across 1 country: China