Clinical trial NCT06683118: Registration Trial of the Drug-coated Balloon for the Symptomatic Cerebral Atherosclerotic Stenosis
Official title: A PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SUPERIORITY, RANDOMIZED, CONTROLLED REGISTRATION TRIAL OF THE RAPAMYCIN NEUROVASCULAR BALLOON CATHETER FOR THE TREATMENT OF SYMPTOMATIC CEREBRAL ATHEROSCLEROTIC STENOSIS
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cerebral Atherosclerotic Stenosis
Lead sponsor: MicroPort NeuroTech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-12
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the trail is to determine whether DCB is superior to conventional balloon in treating cerebral atherosclerotic stenosis


Eligibility 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.

Primary outcomes:
measure: Target lesion restenosis rate at 6 month postoperative
timeFrame: 180±30days
Secondary outcomes:
measure: Technical succeed rate
timeFrame: Intraoperation
measure: Target vascular-related stroke or death at 30 days postoperatively
timeFrame: 30±7days
measure: Any stroke or death at 30 days postoperatively
timeFrame: 30±7days
measure: Target vascular-related stroke or death at 6 month postoperatively
timeFrame: 180±30days
measure: Any stroke or death at 6 month postoperatively
timeFrame: 180±30days
measure: Target vascular-related stroke or death at 12 month postoperatively
timeFrame: 360±60days
measure: Any stroke or death at 12 month postoperatively
timeFrame: 360±60days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Tiantan Hospital Affiliated of Peking University
state: Beijing
city: Shanghai
country: China
facility: Huashan Hospital Affiliated of Fudan University
state: Shanghai
Study officials:
References: