A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Efficacy and Safety of an Intracranial Self-expanding Drug Eluting Stent System for Symptomatic Intracranial Atherosclerotic Disease

Sinomed Neurovita Technology Inc.14 sites in 1 country128 target enrollmentJuly 4, 2022

ConditionsIntracranial Arterial Diseases Stent Restenosis Percutaneous Transluminal Angioplasty

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intracranial Arterial Diseases
Sponsor: Sinomed Neurovita Technology Inc.
Enrollment: 128
Locations: 14
Primary Endpoint: The incidence of In-stent restenosis within 6 months after operation
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IS- DES in patients with symptomatic intracranial atherosclerotic stenosis.

Detailed Description

This study is a prospective, multicenter, objective performance criteria clinical trial to evaluate the safety and efficacy of intracranial self-expanding drug stent system in the treatment of symptomatic intracranial atherosclerotic stenosis. A total of 128 patients are planned to be included. The primary endpoint is the incidence of In-stent restenosis at 6 months after operation (ISR is defined as stenosis greater than 50% within or immediately adjacent (within 5 mm) to the implanted stents and absolute luminal loss greater than 20% at 6 months follow-up imaging.). All patients will have clinical follow-up during intraoperative, 30 days, 6 months, 1 year.

Registry

clinicaltrials.gov

Start Date

July 4, 2022

End Date

March 29, 2024

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sinomed Neurovita Technology Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•30 to 75 years of age;
•Patients with symptomatic intracranial atherosclerotic stenosis who failed antiplatelet therapy or poor collateral circulation compensation or hypoperfusion in the territory of the culprit artery;
•Digital Subtraction Angiography(DSA) showed 70% to 99% stenosis in target intracranial artery
•The target lesion was in the internal carotid artery (intracranial segment), middle cerebral artery, vertebral artery (intracranial segment), basilar artery, and it was a single lesion that required surgical treatment;
•The target lesion reference diameter must be visually estimated to be ≥2.0 mm and \<4.5mm in diameter, and lesion length of ≤34 mm;
•The onset of the latest transient ischemic attack (TIA) was not limited or ischemic stroke occurred within 2 weeks prior to stenting procedure;
•Willingness to participate in this clinical trial and signing the consent form, and be able to complete the corresponding inspections, follow-ups, etc. according to the requirements of the clinical protocol during the clinical trial.

Exclusion Criteria

•The target vessels was complete occlusion;
•\>70% stenosis observed at the intracranial large-vessel distal to the target vessel or \>70% stenosis observed at the intracranial/extracranial large-vessel proximal to the target vessel;
•Preoperative magnetic resonance only showed perforating infarction in the target lesion area;
•Preoperative CT or MRI showed that there was hemorrhage transformation after infarction in the target vessel area, or a history of primary cerebral hemorrhage, or a history of subarachnoid, subdural and epidural hemorrhage within 30 days before operation, or there was no treatment Chronic subdural hematoma ≥5mm;
•Hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery;
•CT showed Severe calcified lesions;
•Previously received endovascular treatment or surgical intervention at the target vessel (except for patients with simple balloon dilatation);
•Non-atherosclerosis lesions;
•Patients with potential sources of cardiac embolism (such as atrial fibrillation, left ventricular thrombosis, myocardial infarction within 6 weeks);
•Concomitant intracranial tumor, aneurysm or intracranial arteriovenous malformation;

Outcomes

Primary Outcomes

The incidence of In-stent restenosis within 6 months after operation

Time Frame: 6 months after operation

ISR is defined as stenosis greater than 50% within or immediately adjacent (within 5 mm) to the implanted stents and absolute luminal loss greater than 20% at 6 months follow-up imaging.

Secondary Outcomes

Procedure success(Immediately after operative)
Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at 6 months follow-up(6 months after operation)
Incidence of device defects(During operation)
Stent success(Immediately after operative)
Rate of good functional outcomes measured by Modified Rankin Score (mRS)(30days, 6 months, 1 year after operation)
Rate of all revascularization and target lesion revascularization(30days, 31days to 6 months, 1 year after operation)
The incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months, 1 year after operation.(31days to 6 months, 1 year after operation)
The incidence of recurrent ischemic stroke outside the target vascular area within 31 days to 6 months, 1 year after operation.(31 days to 6 months, 1 year after operation)
All cause death(31days to 6 months, 1 year after operation)
Symptomatic ISR within 6 months(within 6 months)
Adverse events or severe adverse event(31 days to 6 months, 1 year after operation)
Any stroke or death within 30 days after operation, and the incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months, 1 year after operation.(30days, 31days to 6 months, 1 year after operation)
Any stroke or death within 30 days after operation(Within 30 days after operation)
Stroke (including hemorrhage or ischemic stroke) or death within 30 days associated with the target vessel(Within 30 days after operation)
Any parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage(31 days to 6 months, 1 year after operation)