A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Intracranial Drug-coated Balloon Catheters in the Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Intracranial Atherosclerosis
- Sponsor
- Acotec Scientific Co., Ltd
- Enrollment
- 180
- Locations
- 3
- Primary Endpoint
- Primary efficacy endpoint: Angiographic restenosis of the target lesion
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of the RCT trial is to determine whether DCB is not inferior to stent in treating intracranial stenosis.
Detailed Description
This trial is a prospective, multi-center, 1:1 randomized using paclitaxel coated balloon versus stent to treat intracranial stenosis of 70-99% degree. And primary endpoint is angiographic restenosis at 6 months post-procedure.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 to 80 years of age;
- •Patients with symptomatic intracranial atherosclerotic stenosis;
- •Patients with intracranial arterial de novo stenosis confirmed by digital subtraction angiography (DSA);
- •Confirmed by DSA，the diameter of the target vessel is between 2.5mm-4.5mm ; according to WASID method, the degree of stenosis of the target lesion is 70%-99%;
- •Baseline mRS score ≤2;
- •Voluntarily participate in this study and sign the informed consent form.
Exclusion Criteria
- •Patients with stroke within 2 weeks before procedure;
- •Patients with stroke caused by perforating artery occlusion;
- •Any history of brain parenchymal or other intracranial subarachnoid, subdural or extradural hemorrhage in the past 30 days;
- •Those who have received thrombolysis within 24 hours before procedure;
- •Deterioration of neurological function within 24 hours before procedure (defined as NIHSS score increased by ≥ 4 points over the baseline);
- •The vascular path showed in angiography is so tortuous that it is difficult to advance catheters to the target lesion or retrieve;
- •Lesions that investigators believe are not suitable for stenting;
- •Patients with thrombus in target vessel;
- •In addition to the target lesion, there are still other de novo lesion or ISR lesion with more than 70% diameter stenosis in intracranial arteries that need to be treated at the same time;
- •After endovascular treatment of the target lesion, there is still a stenosis of more than 50% in the main blood supplying artery or an obstructive lesion in the distal vessel of target lesion;
Outcomes
Primary Outcomes
Primary efficacy endpoint: Angiographic restenosis of the target lesion
Time Frame: 6 months post-procedure
Definition of Restenosis: 1. Post-procedural residual stenosis \< 30% of target lesion occurs \>50% stenosis within the treated segment at 6 months angiographic follow-up. 2. Post-procedural residual stenosis 30-50% of target lesion occurs \>20% absolute luminal loss within the treated segment at 6 months angiographic follow-up.
Primary safety endpoint: Target vessel stroke or death event
Time Frame: within 30 days post-procedure
Stroke (Hemorrhagic stroke and ischemic stroke) or death related to target vessels within 30 days postoperatively.
Secondary Outcomes
- Cerebral parenchyma hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage events(between 31 days and 6 months post-procedure)
- Transient ischemic attack event(at 6 months post-procedure)
- Device success rate(during procedure)
- Target vessel ischemia stroke event(between 31 days and 6 months post-procedure)
- Target vessel death event(between 31 days and 6 months post-procedure)
- National Institutes of Health Stroke Scale score(at 6 months post-procedure)
- Modified Rankin Scale score(at 6 months post-procedure)