Effect of Balloon Angioplasty vs Stenting Following Residual Stenosis After Endovascular Treatment of Intracranial Atherosclerotic Acute Ischemic Stroke

NCT07026331 | Active Not Recruiting DMC

• 1 other identifier: ANGEL-ICAS
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate whether rescue balloon angioplasty versus stenting for residual stenosis following endovascular therapy improves neurological outcomes in patients with acute large vessel occlusion due to large-artery atherosclerosis. Patients will be randomized into two groups: the balloon angioplasty group receiving balloon treatment alone followed by standard medical therapy, and the stent group receiving stenting treatment with post-procedural standard medical therapy. The primary efficacy endpoint is the proportion of patients achieving functional independence (modified Rankin Scale 0-2) at 90±7 days, while the safety endpoint is the probability of symptomatic intracranial hemorrhage occurring within 48 hours after randomization.

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke; Intracranial Atherosclerotic; Remedial Balloon Therapy; Stenting; Endovascular Treatment

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with mRS 0-2

  Proportion of patients with Modified Rankin Scale (mRS) 0-2, Modified Rankin Scale（0-6）, A lower MRS score indicates better functional status for the patient.

  90±7 days

Secondary Outcomes (12)

• Vascular recanalization rate assessed by CT/MR angiography

  36±12 hours post-randomization

• Change in NIHSS score from baseline

  36±12 hours post-randomization

• Change in infarct volume

  7±3 days post-randomization or discharge

• Distribution of mRS scores

  7±3 days/discharge; 90±7 days post-randomization

• Proportion of patients achieving mRS 0-1

  90±7 days

Study Arms (2)

Balloon Group

EXPERIMENTAL

Balloon angioplasty followed by standard medical therapy post-procedure

Procedure: balloon angioplasty

Stent Group

ACTIVE COMPARATOR

Stenting treatment, followed by standard medical therapy after the endovascular treatment.

Procedure: Stent

Interventions

balloon angioplasty PROCEDURE

Balloon angioplasty treatment followed by standard medical therapy post-procedure.

Balloon Group

Stent PROCEDURE

Patients will receive either balloon-assisted stenting or direct stenting, followed by standard medical therapy after the endovascular treatment.

Stent Group

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years
• Pre-stroke modified Rankin Scale (mRS) score of 0-1
• Acute ischemic stroke symptoms present within 24 hours of last known well time
• Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥6
• Anterior circulation: Alberta Stroke Program Early CT Score (ASPECTS) ≥6 / Posterior circulation: pc-ASPECTS ≥6
• Occlusion of intracranial internal carotid artery (ICA), M1 segment of middle cerebral artery (MCA), V4 segment of vertebral artery, or basilar artery
• Clinical care team plans to perform endovascular thrombectomy (EVT)
• Subject or legally authorized representative can provide informed consent
• Residual stenosis ≥50% with planned angioplasty/stenting

You may not qualify if:

• Intracranial hemorrhage confirmed by imaging prior to randomization, or major intracranial hemorrhage on intraprocedural flat-panel CT
• Gastrointestinal or genitourinary bleeding within 30 days post-stroke onset, or major surgery within 14 days
• Bleeding diathesis including coagulopathy (platelets \<100×10⁹/L, aPTT \>50s, or INR \>2.0), DOAC use within 48 hours, or history of HIT
• Pregnancy or lactation at admission
• Contraindications to radiographic contrast agents, nickel, titanium or their alloys
• Life expectancy \<6 months
• Pre-existing neurological/psychiatric conditions that may confound assessment
• Severe renal insufficiency (GFR \<30mL/min or Scr \>220μmol/L \[2.5mg/dL\])
• Arterial tortuosity or anomalies preventing device delivery
• Unlikely to complete 90-day follow-up
• Any confirmed cardioembolic source (including atrial fibrillation, valvular disease, intracardiac thrombus, recent MI, cardiomyopathy with EF \<30%, etc.)
• Tirofiban or other GP IIb/IIIa inhibitor use before randomization or planned post-treatment

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 101118, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Angioplasty, Balloon; Stents

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 18, 2025
• Study Start: July 3, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)