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Researchers are evaluating the effectiveness of drug-eluting stents combined with aggressive medical treatment compared to standard medical treatment alone in preventing stroke recurrence within one year for patients with symptomatic intracranial atherosclerotic disease. This prospective, multi-center, randomized trial focuses on patients who have experienced ischemic stroke related to severe narrowing of major intracranial arteries. The study aims to assess stroke and death rates within 30 days of enrollment or revascularization procedures, as well as ischemic strokes occurring up to one year after enrollment. Participants are randomly assigned to receive either a drug-eluting sirolimus stent implanted using a balloon-expandable system along with aggressive medical treatment or standard medical treatment alone. Aggressive treatment includes dual antiplatelet therapy with aspirin plus clopidogrel or ticagrelor for six months, while standard treatment involves similar medications for three months. Both groups receive risk factor management addressing hypertension, diabetes, lipid metabolism, smoking, and exercise. The stent system features a rapid exchange catheter with a semi-compliant balloon for intracranial artery treatment. During the study, participants undergo regular monitoring to track any strokes, death, or bleeding complications over 12 months. Key assessments include clinical evaluations and safety monitoring for bleeding severity using the GUSTO score. The trial measures the occurrence of stroke or death within the first 30 days after enrollment or revascularization and ischemic strokes in the treated artery territory from 31 days to one year. The total follow-up period lasts 12 months to evaluate the long-term outcomes of these treatments.

Age: 18Years - 85YearsAll GendersPhase Not Applicable
18 locations
Wu Hai Shi Clinical Trials | DecenTrialz