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The Efficacy and Safety of Intracranial Self-expanding DES in Symptomatic Intracranial Atherosclerotic Disease

Stent Restenosis Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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, and 2 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05217459
Study type Interventional
Source Sinomed Neurovita Technology Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date July 4, 2022
Completion date June 2024
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