Clinical trial NCT07026331: Effect of Balloon Angioplasty vs Stenting Following Residual Stenosis After Endovascular Treatment of Intracranial Atherosclerotic Acute Ischemic Stroke
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: Acute Ischemic Stroke
Intracranial Atherosclerotic
Remedial Balloon Therapy
Stenting
Endovascular Treatment
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Proportion of patients with mRS 0-2
timeFrame: 90±7 days
Secondary outcomes:
measure: Vascular recanalization rate assessed by CT/MR angiography
timeFrame: 36±12 hours post-randomization
measure: Change in NIHSS score from baseline
timeFrame: 36±12 hours post-randomization
measure: Change in infarct volume
timeFrame: 7±3 days post-randomization or discharge
measure: Distribution of mRS scores
timeFrame: 7±3 days/discharge; 90±7 days post-randomization
measure: Proportion of patients achieving mRS 0-1
timeFrame: 90±7 days
measure: Proportion of patients achieving mRS 0-3
timeFrame: 90±7 days
measure: Incidence of Pharmacologic rescue therapy
timeFrame: 90±7 days
measure: Incidence of rescue therapy
timeFrame: 90±7 days
measure: EQ-5D-5L utility score
timeFrame: 90±7 days
measure: Symptomatic intracranial hemorrhage
timeFrame: 48 hours
measure: All-cause mortality
timeFrame: 90±7 days
measure: Probability of any intracranial hemorrhage
timeFrame: 48 hours post-randomization
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital Affiliated to Capital Medical University
state: Beijing
Study officials:
References: