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

NCT ID: NCT07026331

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 322 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-03
• Study Completion Date: 2027-06-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Balloon Group

Balloon angioplasty followed by standard medical therapy post-procedure

Group Type: EXPERIMENTAL

balloon angioplasty

Intervention Type: PROCEDURE

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

Stent Group

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

Group Type: ACTIVE_COMPARATOR

Stent

Intervention Type: PROCEDURE

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

Interventions

balloon angioplasty

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

Intervention Type: PROCEDURE

Stent

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years

2. Pre-stroke modified Rankin Scale (mRS) score of 0-1

3. Acute ischemic stroke symptoms present within 24 hours of last known well time

4. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥6

5. Anterior circulation: Alberta Stroke Program Early CT Score (ASPECTS) ≥6 / Posterior circulation: pc-ASPECTS ≥6

6. Occlusion of intracranial internal carotid artery (ICA), M1 segment of middle cerebral artery (MCA), V4 segment of vertebral artery, or basilar artery

7. Clinical care team plans to perform endovascular thrombectomy (EVT)

8. Subject or legally authorized representative can provide informed consent

9. Residual stenosis ≥50% with planned angioplasty/stenting

Exclusion Criteria

1. Intracranial hemorrhage confirmed by imaging prior to randomization, or major intracranial hemorrhage on intraprocedural flat-panel CT

2. Gastrointestinal or genitourinary bleeding within 30 days post-stroke onset, or major surgery within 14 days

3. Bleeding diathesis including coagulopathy (platelets <100×10⁹/L, aPTT >50s, or INR >2.0), DOAC use within 48 hours, or history of HIT

4. Pregnancy or lactation at admission

5. Contraindications to radiographic contrast agents, nickel, titanium or their alloys

6. Life expectancy <6 months

7. Pre-existing neurological/psychiatric conditions that may confound assessment

8. Severe renal insufficiency (GFR <30mL/min or Scr >220μmol/L [2.5mg/dL])

9. Arterial tortuosity or anomalies preventing device delivery

10. Unlikely to complete 90-day follow-up

11. Any confirmed cardioembolic source (including atrial fibrillation, valvular disease, intracardiac thrombus, recent MI, cardiomyopathy with EF <30%, etc.)

12. Tirofiban or other GP IIb/IIIa inhibitor use before randomization or planned post-treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Anzhen Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

ANGEL-ICAS

Identifier Type: -

Identifier Source: org_study_id