iCAST Balloon-Expandable Covered Stent for Iliac Artery Lesions: 3-Year Results from the iCARUS Multicenter Study
Year: 2019
Type: article
Study design: Clinical Trial
Abstract: 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) 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), which was below the performance goal of 16.57%. Nine-month primary patency, defined as continuous flow without revascularization, bypass, or target limb amputation, was 96.4%. Freedom from TLR at 9 months and 3 years was 97.2% and 86.6%, respectively. Early clinical success was seen in 88.7% of subjects at 30 days with sustained clinical benefit in 72.4% of subjects at 3 years. CONCLUSIONS: The iCARUS study demonstrated that the iCAST Covered Stent was safe and effective for treatment of atherosclerotic iliac artery lesions with sustained clinical benefit out to 3 years.
Institutions: Adventist Heart Institute, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Emory University Hospital, Community Health Systems - Tennova Turkey Creek Medical Center, Midwest Cardiovascular Research Foundation, Dartmouth–Hitchcock Medical Center, Beth Israel Deaconess Medical Center, Harvard University, Boston University
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,000
Funders: Massachusetts General Hospital, Emory University, Northwestern University, Cleveland Clinic, Cleveland Clinic Foundation, Clinical Trial Center, China Medical University Hospital, University of Louisville, Dartmouth College, University of Arkansas for Medical Sciences, Ochsner Health, University of California, Davis
OpenAlex ID: W2942066717