Cerebral Atherosclerotic Stenosis
Conditions
Brief summary
The purpose of the trail is to determine whether DCB is superior to conventional balloon in treating cerebral atherosclerotic stenosis
Interventions
DEVICERapamycin neurovascular Balloon Catheter
Drug-coated balloon for the symptomatic cerebral atherosclerotic stenosis
DEVICEConventional Balloon
Conventional Balloon for the symptomatic cerebral atherosclerotic stenosis
Sponsors
MicroPort NeuroTech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Incsion Criteria: * Age 18 to 80 years old at informed consent signing. * Symptomatic atherosclerotic stenosis of cerebrovascular arteries with ≥70% stenosis. * Medication ineffective. * modified Rankin Scale(mRS) score≤2. * The subject or guardian is able to understand the purpose of the study, is willing to participate and has given written informed consent.
Exclusion criteria
* History of acute ischemic stroke within 2 weeks; * Stenosis due to non-atherosclerotic lesions such as arterial dissection, Moya-Moya disease and vasculitic disease; * Target vessels complete occlusion or with thrombus in target vessels; * Target vessel with severe calcification or distortion that making interventional device is difficult to place; * History of stenting in the target artery; * Target vessel restenosis following stenting or balloon angioplasty; * Combined with other lesion with ≥70% stenosis in target vessel. * Residual stenosis ≥50% or vessel dissection with obvious blood flow restriction occurs after predilation. * Combined with intracranial tumour, arteriovenous malformation or aneurysm of the target vessel. * History of intracranial hemorrhage within 90days. * Presence of severe systemic diseases that cannot tolerate surgery, such as severe liver and kidney dysfunction; * Contraindication to the use of anticoagulants and antiplatelet agents, such as sllergy to anticoagulants and antiplatelet agents, active bleeding or coagulation disorders; * Allergic to contrast agents or rapamycin; * Pregnant or lactating women; * Participating or intending to participate in any other drug/device clinical trials; * Life expectancy \<1 year; * Any other conditions that the investigator deems the patient unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion restenosis rate at 6 month postoperative | 180±30days | The primary endpoint was the restenosis rate at 6 month postoperatively. Restenosis was defined as ≥50% measured stenosis of the target lesion by imaging according to WASID method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target vascular-related stroke or death at 30 days postoperatively | 30±7days | — |
| Any stroke or death at 30 days postoperatively | 30±7days | — |
| Target vascular-related stroke or death at 6 month postoperatively | 180±30days | — |
| Technical succeed rate | Intraoperation | defined as smooth delivery of the device to the target lesion and successful dilatation, unloading, and retraction |
| Target vascular-related stroke or death at 12 month postoperatively | 360±60days | — |
| Any stroke or death at 12 month postoperatively | 360±60days | — |
| Any stroke or death at 6 month postoperatively | 180±30days | — |
Countries
China
Outcome results
None listed