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

NCT06683118 | Enrolling By Invitation

• 1 other identifier: JUJI-2023-01-CIP-00
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cerebral Atherosclerotic Stenosis

Outcome Measures

Primary Outcomes (1)

• Target lesion restenosis rate at 6 month postoperative

  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.

  180±30days

Secondary Outcomes (7)

• Technical succeed rate

  Intraoperation

• 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

• Any stroke or death at 6 month postoperatively

  180±30days

Study Arms (2)

experimental group

EXPERIMENTAL

Device: Rapamycin neurovascular Balloon Catheter

control group

ACTIVE COMPARATOR

Device: Conventional Balloon

Interventions

Rapamycin neurovascular Balloon Catheter DEVICE

Drug-coated balloon for the symptomatic cerebral atherosclerotic stenosis

experimental group

Conventional Balloon DEVICE

Conventional Balloon for the symptomatic cerebral atherosclerotic stenosis

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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;

Sponsors & Collaborators

• MicroPort NeuroTech Co., Ltd.: lead

Study Sites (2)

Tiantan Hospital Affiliated of Peking University

Beijing, Beijing Municipality, China

Location

Huashan Hospital Affiliated of Fudan University

Shanghai, Shanghai Municipality, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 12, 2024
• Study Start: May 27, 2024
• Primary Completion: July 27, 2025
• Study Completion (Estimated): July 27, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-08

Locations

CN (2)