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NOT YET RECRUITING
NCT07830277
NA

Drug-coated Balloon for Endovascular Treatment Versus Aggressive Medical Management in High-Risk Symptomatic Intracranial Atherosclerotic Stenosis

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

Summary

DR.BEYOND-2 is an investigator-initiated, prospective, multicenter, randomized, open-label, blinded-endpoint, parallel-group clinical trial designed to evaluate the efficacy and safety of drug-coated balloon (DCB) angioplasty plus aggressive medical management compared with aggressive medical management alone in patients with high-risk symptomatic intracranial atherosclerotic stenosis (sICAS). A total of 570 eligible patients will be randomized in a 1:1 ratio to the DCB group or the medical management group. Patients assigned to the DCB group will undergo DCB angioplasty in addition to aggressive medical management, with rescue stenting permitted when clinically necessary according to the study protocol. Patients assigned to the control group will receive aggressive medical management alone. The primary endpoint is the composite of any stroke or death within 30 days after enrollment and ischemic stroke in the territory of the qualifying artery from day 31 through 1 year. Participants will be followed for up to 3 years to further evaluate recurrent ischemic events, vascular outcomes, functional outcomes, and long-term safety.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

570

Start Date

2026-10-01

Completion Date

2031-06-01

Last Updated

2026-09-21

Healthy Volunteers

No

Interventions

PROCEDURE

Drug-Coated Balloon Angioplasty

Participants randomized to the experimental group will undergo intracranial drug-coated balloon angioplasty using a submaximal angioplasty strategy. Predilation with an uncoated balloon is performed before drug-coated balloon angioplasty. Rescue stenting is permitted when severe dissection, residual stenosis \>50%, marked elastic recoil, or other protocol-defined conditions occur.

OTHER

Aggressive Medical Management

Aggressive medical management will be provided to participants in both groups and includes antiplatelet therapy, intensive lipid-lowering treatment, blood pressure and glucose control, and management of other vascular risk factors. Aspirin 100 mg/day is administered throughout follow-up, with clopidogrel 75 mg/day during the first 90 days after enrollment. Alternative antiplatelet therapy may be used according to platelet function or CYP2C19 genotype when appropriate.

Locations (2)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Baotou Central Hospital

Baotou, Inner Mongolia, China