Registration Trial of the Drug-coated Balloon for the Symptomatic Cerebral Atherosclerotic Stenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-27

Study Completion Date

2026-07-27

Brief Summary

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

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Detailed Description

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Conditions

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Cerebral Atherosclerotic Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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experimental group

Group Type EXPERIMENTAL

Rapamycin neurovascular Balloon Catheter

Intervention Type DEVICE

Drug-coated balloon for the symptomatic cerebral atherosclerotic stenosis

control group

Group Type ACTIVE_COMPARATOR

Conventional Balloon

Intervention Type DEVICE

Conventional Balloon for the symptomatic cerebral atherosclerotic stenosis

Interventions

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Rapamycin neurovascular Balloon Catheter

Drug-coated balloon for the symptomatic cerebral atherosclerotic stenosis

Intervention Type DEVICE

Conventional Balloon

Conventional Balloon for the symptomatic cerebral atherosclerotic stenosis

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No