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Paclitaxel Drug-eluting Balloon Catheters in the Treatment of Symptomatic Intracranial Atherosclerotic Stenosis and Restenosis

Stroke Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06047964
Study type Interventional
Source B. Braun Medical International Trading Company Ltd.
Contact Iris Zhang
Phone +86 10 5763 2775
Email Iris.zhang@bbraun.com
Status Recruiting
Phase N/A
Start date March 23, 2023
Completion date January 23, 2025
View Details
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