Stent-assisted Angioplasty of the Offending Intracranial Stenosis plus Optimal Medical Therapy versus Optimal Medical Therapy Alone "ASSIST II"

Completed

Phase N/A Results

Results

: Forty-four lesions (91.7%) obtained stent success within a median procedural time of 50.6 minutes. Severe tortuosity correlated with stent failure. Three patients (6.5%, 3/46) had minor strokes within 30 days. All patients were available for follow-up (46 had 30-day follow-up, 45 had 6-month follow-up, 44 had 12- and 18-month follow-up, and 24 had follow-up of 24 months), which varied from 1 month to 30.7 months (median, 23.9 months). After 30 days, 1 patient (2.2%, 1/46) developed minor stroke in the target-lesion artery territory at 6.7 months. Primary end point rate was 4.3 per 100 patient years. Angiographic follow-up was performed in 25 patients. Seven restenoses (28%, 7/25) were detected, 1 of which was symptomatic. CONCLUSION: Angioplasty with the Apollo stent for symptomatic atherosclerotic intracranial stenosis is feasible. Severe tortuosity is an independent predictor of stent failure. Our clinical outcome seems to compare favorably with results of aspirin therapy, but the restenotic rate was high.