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NCT Number: NCT07026331

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anzhen Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 101118, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Balloon angioplasty

Procedure

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

stent

Procedure

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

Primary outcomes

  1. Proportion of patients with mRS 0-2

    Time frame: 90±7 days

    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.

Secondary outcomes

  1. Vascular recanalization rate assessed by CT/MR angiography

    Time frame: 36±12 hours post-randomization

    Vascular recanalization rate assessed by CT/MR angiography

  2. Change in NIHSS score from baseline

    Time frame: 36±12 hours post-randomization

    Change in National Institute of Health stroke scale score from baseline.The NIH Stroke Scale (NIHSS) score ranges from 0 to 42 points, with lower scores indicating better neurological function

  3. Change in infarct volume

    Time frame: 7±3 days post-randomization or discharge

    Change in infarct volume

  4. Distribution of mRS scores

    Time frame: 7±3 days/discharge; 90±7 days post-randomization

    Modified Rankin Scale（0-6）, A lower MRS score indicates better functional status for the patient.

  5. Proportion of patients achieving mRS 0-1

    Time frame: 90±7 days

    Proportion of patients achieving mRS 0-1, Modified Rankin Scale（0-6）, A lower MRS score indicates better functional status for the patient.

  6. Proportion of patients achieving mRS 0-3

    Time frame: 90±7 days

    Proportion of patients achieving mRS 0-3

  7. Incidence of Pharmacologic rescue therapy

    Time frame: 90±7 days

    Incidence of Pharmacologic rescue therapy

  8. Incidence of rescue therapy

    Time frame: 90±7 days

    Incidence of rescue therapy

  9. EQ-5D-5L utility score

    Time frame: 90±7 days

    The EuroQol 5-Dimension 5-Level Utility Score (EQ-5D-5L utility score) ranges from -0.594 to 1.000 (Chinese value set), assessing health-related quality of life, with higher scores indicating better health status.

  10. Symptomatic intracranial hemorrhage

    Time frame: 48 hours

    Symptomatic intracranial hemorrhage (Heidelberg Standards)

  11. All-cause mortality

    Time frame: 90±7 days

    All-cause mortality

  12. Probability of any intracranial hemorrhage

    Time frame: 48 hours post-randomization

    Probability of any intracranial hemorrhage (Heidelberg Standards)

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Official study title

Effect of Balloon Angioplasty vs Stenting Following Residual Stenosis After Endovascular Treatment of Intracranial Atherosclerotic Acute Ischemic Stroke: A Multicenter, Prospective, Open-label, Endpoint-blinded, Randomized Controlled Study

Acronym: ANGEL-ICAS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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