Drug-Coated Balloon vs Aggressive Medical Management for High-Risk Symptomatic Intracranial Atherosclerotic Stenosis

NCT07830277 | Not Yet Recruiting DMC

• 1 other identifier: HX-A-2026071-001
• Study Type: interventional
• Target: 570
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Symptomatic Intracranial Atherosclerotic Stenosis

Keywords

Intracranial atherosclerotic stenosis; Symptomatic intracranial atherosclerotic stenosis; Drug-coated balloon; Balloon angioplasty; Endovascular treatment; Aggressive medical management; Ischemic stroke

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Any stroke or death within 30 days after enrollment and recurrence of ischemic stroke in the target vessel area within 30 days to 1 year after enrollment

  Percentage of Participants With Any stroke or death within 30 days after enrollment and recurrence of ischemic stroke in the target vessel area within 30 days to 1 year after enrollment.

  within 30 days after enrollment;within 30 days to 1 year after enrollment

Secondary Outcomes (15)

• Percentage of Participants With Any stroke or death within 30 days after enrollment

  Within 30 days after enrollment

• Percentage of Participants With Recurrent Ischemic Stroke in any region within 30 days to 1 year after enrollment

  Within 30 days to 1 year after enrollment

• Percentage of Participants With Recurrent TIA in the Territory of the Qualifying Artery Within 1 Year After Enrollment

  Within 1 year after enrollment

• Percentage of Participants With Recurrent TIA in Any Vascular Territory Within 1 Year After Enrollment

  Within 1 year after enrollment

• Percentage of Participants Undergoing Target-Vessel Revascularization Within 1 Year After Enrollment

  Within 1 year after enrollment

Other Outcomes (16)

• Changes in Target-Vessel Imaging Characteristics Assessed by High-Resolution MRI at 1 Year (±1 Month) After Enrollment

  1 year (± 1 month) after enrollment

• Percentage of Participants With Recurrent Ischemic Stroke in Any Vascular Territory Within 3 Years After Enrollment

  Within 3 years after enrollment

• Percentage of Participants With Recurrent Ischemic Stroke in the Territory of the Qualifying Artery Within 3 Years After Enrollment

  Within 3 years after enrollment

Study Arms (2)

Drug-Coated Balloon Angioplasty Plus Aggressive Medical Management

EXPERIMENTAL

Participants assigned to this group will undergo drug-coated balloon angioplasty in addition to aggressive medical management. Rescue stenting is permitted when clinically necessary according to predefined procedural criteria, including severe dissection, significant residual stenosis, or marked elastic recoil.

Procedure: Drug-Coated Balloon Angioplasty

Aggressive Medical Management Alone

ACTIVE COMPARATOR

Participants assigned to this group will receive aggressive medical management alone, including standardized antiplatelet therapy and intensive management of vascular risk factors.

Other: Aggressive Medical Management

Interventions

Drug-Coated Balloon Angioplasty PROCEDURE

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.

Drug-Coated Balloon Angioplasty Plus Aggressive Medical Management

Aggressive Medical Management OTHER

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.

Aggressive Medical Management Alone

Eligibility Criteria

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

You may qualify if:

• Age 18-80 years old, regardless of gender
• Patients with symptomatic ICAS caused by stenosis of a major intracranial artery (the degree of ischemic stroke with target vessel stenosis within 90 days before enrollment is required to be 70-99%, or the degree of transient ischemic attack with target vessel stenosis is required to be 80-99%), standardized drug management of at least one antithrombotic drug and/or vascular risk factors
• DSA or CTA confirmed that the stenosis degree of one main intracranial artery (internal carotid artery C4-C7 segment, middle cerebral artery M1 segment, vertebral artery V4 segment and basilar artery) was between 70% and 99% (measured by WASID method), and was corresponding to the clinical symptoms. The normal diameter of the proximal end of the target lesion was ≥ 2mm, and the length of the target lesion was ≤ 15mm
• If the target lesion is located in the anterior circulation system (C4-C7 of the internal carotid artery or M1 of the middle cerebral artery), it is required that there is hypoperfusion in the blood supply area of the target vessel (at least one of the following conditions is met): ①head CTP or PWI showed that CBF in the target vessel area decreased significantly (the lesion side decreased by more than 30% compared with the opposite side); ②Cerebral infarction with hemodynamic abnormalities confirmed by head CT or MRI (such as watershed infarction); ③ASITN/SIR collateral circulation score based on DSA\<3 points)
• Those who voluntarily participated in the study and signed the informed consent

You may not qualify if:

• Serious calcification of target vessels, or serious distortion of target vessels or anatomical factors make it difficult for interventional instruments to be in place
• Severe stenosis or occlusion of extracranial or intracranial vessels in series at the proximal or distal end of the target vessel
• Major surgical operations have been performed in recent 3 weeks
• Cerebral hemorrhage, massive cerebral infarction (the infarct area is greater than 50% of the middle cerebral artery supply area; cerebellar infarction: the infarct diameter is greater than 3cm) and myocardial infarction have occurred in the past three months
• The target lesion has undergone stent implantation before
• Intracranial artery stenosis caused by non atherosclerotic lesions, including but not limited to: arterial dissection, moyamoya disease, vasculitis, radiation vascular disease or fibromuscular dysplasia
• mRS score ≥ 3
• Patients with coagulation dysfunction
• Those who cannot tolerate anesthesia and anticoagulant drugs, are contraindicated or allergic to surgical drugs (paclitaxel, heparin, contrast agent, aspirin, clopidogrel, etc.), and are allergic to surgical instruments or operating devices
• Platelet (PLT\<90×109/L),hematocrit (\<30%), international normalized ratio (INR)\>1.5, uncontrollable severe hypertension (systolic blood pressure\>180mmHg or diastolic blood pressure\>110mmHg),severe liver injury (ALT or AST more than 3 times the normal value), severe renal function injury (creatinine\>3mg/dl,\>265μmol/L),and severe insufficiency of other important organs such as heart and lung
• The subjects participated in other clinical trials and have not completed the follow-up or the researchers judged that the patients' compliance was poor and they were unable to complete the follow-up as required
• Pregnant or lactating women, or those who plan to become pregnant within one year
• The disease will cause difficulties in treatment and follow-up evaluation (such as dementia or mental disorders, cancer, infection, severe metabolic diseases), and it is speculated that the life expectancy of the participants is less than 3 years
• Other cases that clinicians think should be excluded

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Baotou Central Hospital: collaborator

Study Sites (2)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100010, China

Location

Baotou Central Hospital

Baotou, Inner Mongolia, 014000, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Changchun Jiang, MD

  Baotou Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changchun Jiang, MD

CONTACT

13347180510; 15848246828@163.com

Dapeng Mo, MD

CONTACT

18811039300; bjttmodp@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-Director of Interventional Neuroradiology, Department of Neurology

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 21, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 1, 2031
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)