iCAST Balloon | 合法醫療器材資訊網

由JRLaird著作·2019·被引用10次—TheiCARUSstudydemonstratedthattheiCASTCoveredStentwassafeandeffectivefortreatmentofatheroscleroticiliacarterylesionswithsustained ...

Purpose: To evaluate safety and effectiveness of the iCAST Covered Stent for treatment of iliac artery atherosclerotic lesions.

Materials and methods: The iCARUS trial (ClinicalTrials.gov Identifier: NCT00593385[1]) was a single-arm, prospective, multicenter study that enrolled 152 per protocol subjects at 25 sites in the United States and Germany. Subjects with multiple lesions and/or stents were eligible. The primary endpoint was the composite rate of death within 30 days, target lesion revascularization (TLR) within 9 months, or restenosis at 9 months after procedure. Secondary endpoints included major adverse vascular events (MAVEs), primary patency, freedom from TLR, and clinical success.

Results: Device and acute procedural success were achieved in 98.7% and 92.7% of cases, respectively. MAVE rate was 4.6% at 30 days. The 9-month primary composite endpoint rate was 8.1% (10/123), ...