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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
281
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Nanyang Central Hospital
Nanyang, Henan, China
restenosis incidence of target lesion
angiographic restenosis measured by WASID ( Warfarin-Aspirin Symptomatic Intracranial Disease) method in core-lab
Time frame: 6 months post-procedure
Device success rate
Successful delivery, dilatation and withdraw of the balloon
Time frame: baseline procedure
The changes of Modified Rankin Scale(mRS) score
Scores range from 0 to 6, with higher scores indicating more severe nerve damage; Change of mRS score = mRS score at 6 months (12 months) after surgery - mRS score at baseline
Time frame: 6 and 12 months post-procedure
The changes of NIH Stroke Scale(NIHSS) score
Scores range from 0 to 42, with higher scores indicating more severe nerve damage; Change of NIHSS score = NIHSS score at 6 months (12 months) after surgery - NIHSS score at baseline.
Time frame: 6 and 12 months post-procedure
Number and incidence (%) of target vessel stroke events (including ischemic or hemorrhagic stroke), transient ischemic attack
Incidence of target vessel stroke events (%) = (number of subjects with target vessel stroke events/total number of subjects) × 100%. Incidence of transient ischemic attacks (%) = (number of subjects with transient ischemic attacks/total number of subjects) × 100%.
Time frame: 6 and 12 months post-procedure
Recurrence incidence of ipsilateral ischemic stroke
Recurrence incidence of ipsilateral ischemic stroke (%) = (number of subjects with recurrent ipsilateral ischemic stroke/total number of subjects) × 100%.
Time frame: 30 days, 6 and 12 months post-procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The First Hospital of Jilin University
Changchun, Jilin, China
Jining First People's Hospital
Jining, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Renji Hospital, Shanghai Jiaotong University, School of Medicine
Shanghai, Shanghai Municipality, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China