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Actively Recruiting

Phase 3
Age: 18Years - 79Years
All Genders
ID05611242

Study Comparing Mechanical Thrombectomy With and Without Carotid Stenting for Acute Ischemic Stroke in Adults Aged 18 to 79

Led by Mercy Health Ohio · Updated on 2025-12-17

404

Participants Needed

51

Research Sites

60 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of two approaches for treating acute ischemic stroke caused by a blockage in the anterior circulation of the brain with a related blockage or severe narrowing in the proximal carotid artery. The study compares intra-arterial mechanical thrombectomy combined with either carotid artery stenting or non-stenting methods. This phase III trial is designed as a randomized, open-label study with blinded outcome assessment to determine which treatment better helps recovery at 3 months and one year. Participants will be randomly assigned to one of two groups. One group receives best medical management plus mechanical thrombectomy and a non-stenting approach for the proximal carotid artery blockage, such as angioplasty or aspiration. The other group receives best medical management plus mechanical thrombectomy along with acute carotid stenting of the extracranial proximal carotid artery, with subgroups based on different antiplatelet medication protocols. Procedures use FDA-cleared devices, and the order of treatment is decided by the treating physician. During the study, patients are monitored and assessed at 3 months and 1 year after treatment to evaluate their recovery using the Modified Rankin Scale. An independent reviewer not involved in the treatment will perform these assessments. Optional remote evaluations of neurological status may be offered. The total duration of participation includes initial treatment and follow-up visits to track safety and effectiveness outcomes.

CONDITIONS

Brief Title

Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial

Research Team

J

Jasmine M Olvany, PhD

L

Laila Ibrahim, MPH

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