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 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 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
Trial Locations
- Locations (2)
Tiantan Hospital Affiliated of Peking University
🇨🇳Beijing, Beijing, China
Huashan Hospital Affiliated of Fudan University
🇨🇳Shanghai, Shanghai, China
Tiantan Hospital Affiliated of Peking University🇨🇳Beijing, Beijing, China