NCT05974033

IntraCranial Angiography-derived Fraction Flow-guided Percutaneous Transluminal Angioplasty and Stenting Versus Medical Therapy (ICAS-MT)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 536 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, open-label, blinded-endpoint, prospective, randomized controlled clinical trial with an "all comers" design.

Detailed description

The main objective of this study is to investigate the impact of angiography-derived fractional flow (Angio-FF) on diagnostic and therapeutic decision-making in patients with symptomatic intracranial atherosclerotic stenosis (sICAS). The study aims to evaluate whether stenting plus medical therapy, compared to medical therapy alone, can benefit patients selected through Angio-FF screening. For Group A, patients with significant stenosis and hemodynamic impairment identified through Angio-FF (≤0.7) screening are expected to have a higher risk. The patients will be enrolled in RCT trial, with a planned enrollment of 336 subjects. For Group B, patients with significant stenosis but without hemodynamic impairment identified through Angio-FF (\>0.7) screening will be included in the registry cohort, with a planned enrollment of 200 subjects.

Conditions

• ICAS - Intracranial Atherosclerosis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Stenting plus medical therapy	Patients randomized to intervention group received the percutaneous transluminal balloon angioplasty with stenting within 5 days after randomization, and loading dose of aspirin and clopidogrel was allowed. Received aspirin, 100mg, plus clopidogrel, 75 mg, daily for 90 days after procedure.
DRUG	Medical therapy alone	Medical therapy alone: received aspirin, 100mg, plus clopidogrel, 75 mg, daily for 90 days after randomisation.

Timeline

• Start date: 2023-08-01
• Primary completion: 2025-12-01
• Completion: 2027-12-01
• First posted: 2023-08-03
• Last updated: 2023-08-03