Effect of Balloon Angioplasty vs Stenting Following Residual Stenosis After Endovascular Treatmen… (NCT07026331) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effect of Balloon Angioplasty vs Stenting Following Residual Stenosis After Endovascular Treatment of Intracranial Atherosclerotic Acute Ischemic Stroke
China322 participantsStarted 2025-07-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
Exclusion criteria
✕. Intracranial hemorrhage confirmed by imaging prior to randomization, or major intracranial hemorrhage on intraprocedural flat-panel CT