The Efficacy and Safety of Intracranial Self-expanding DES in Symptomatic Intracranial Atherosclerotic Disease
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
Sponsor: Changhai Hospital
This NA trial investigates Intracranial Arterial Diseases and Percutaneous Transluminal Angioplasty and is currently completed. Changhai Hospital leads this study, which shows 9 recorded versions since 2022 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)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.
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.
Status Flow
Change History
9 versions recorded-
Sep 2025 — Present [monthly]
Completed NA
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Jun 2025 — Sep 2025 [monthly]
Completed NA
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Sep 2024 — Jun 2025 [monthly]
Completed NA
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Jul 2024 — Sep 2024 [monthly]
Completed NA
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Jun 2024 — Jul 2024 [monthly]
Completed NA
Status: Active Not Recruiting → Completed
▶ Show 4 earlier versions
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Nov 2023 — Jun 2024 [monthly]
Active Not Recruiting NA
Status: Recruiting → Active Not Recruiting
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Feb 2023 — Nov 2023 [monthly]
Recruiting NA
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Sep 2022 — Feb 2023 [monthly]
Recruiting NA
Status: Not Yet Recruiting → Recruiting
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Feb 2022 — Sep 2022 [monthly]
Not Yet Recruiting NA
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Changhai Hospital
- Sinomed Neurovita Technology Inc.
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Beijing, China , Changchun, China , Changzhou, China , Guangzhou, China , Hangzhou, China , Ha’erbin, China , Hefei, China , Jinan, China , Qingdao, China , Shanghai, China and 3 more locations