Registration Trial of the Drug-coated Balloon for the Symptomatic Cerebral Atherosclerotic Stenosis
Not Applicable
- Conditions
- Cerebral Atherosclerotic Stenosis
- Registration Number
- NCT06683118
- Lead Sponsor
- MicroPort NeuroTech Co., Ltd.
- Brief Summary
The purpose of the trail is to determine whether DCB is superior to conventional balloon in treating cerebral atherosclerotic stenosis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 212
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Any 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
Any stroke or death at 30 days postoperatively 30±7days Target vascular-related stroke or death at 12 month postoperatively 360±60days Any stroke or death at 12 month postoperatively 360±60days Target vascular-related stroke or death at 30 days postoperatively 30±7days Target vascular-related stroke or death at 6 month postoperatively 180±30days
Trial Locations
- Locations (2)
Tiantan Hospital Affiliated of Peking University
🇨🇳Beijing, Beijing, China
Huashan Hospital Affiliated of Fudan University
🇨🇳Shanghai, Shanghai, China