Monday, August 5, 2019
To evaluate the safety and efficacy of the iCAST Covered Stent for the treatment of iliac artery atherosclerotic lesions
The iCAST balloon-expandable stent was found to be a safe and effective treatment for iliac atherosclerotic lesions with PPR of 96% at 9 months, and clinical improvement in 72.4% at three years.
Laird J, Loga M, Zeller T, Naizi K, Foster M, Ansel G, Stone D, Dave R, Popma J, Jaff M, Massaro J. (2019). iCAST Balloon-Expandable Covered Stent for Iliac Artery Lesions: 3-Year Results from the iCARUS Multicenter Study. J Vasc Interv Rad. 30, 822-829. Doi:10.1016/j.jvir.2018.12.707
Single-arm, prospective, multicenter study
Sponsor Atrium Medical Corporation
24 US cities and 1 German center
Subject-Based Secondary Outcomes in Per Protocol Population.
The iCARUS trial enrolled 165 subjects at 25 different sites, ultimately having 152 subjects with 223 lesions meet inclusion criteria. This included Rutherford class 2-4, stenotic lesions in the common or external iliac arteries <110 mm in length and 5-12 mm in diameter with ≥50 stenosis with concurrent patent profunda or SFA. Baseline ABI of 0.73 ± 0.23 was noted with a total occlusion rate of 17.1%. Primary endpoint was a compositive of the occurrence of death within 30 days, target lesion revascularization (TLR) within 9 months or restenosis of the iliac on US or angio at 9 months.
264 iCAST stents were implanted with mean percent reduction in stenosis from 69.3 ± 16.7% to 2.5 ± 5.7%. Device success was 98.7% with a 9-month, 2-year and 3-year clinical success rate of 76.6%, 70.8% and 72.4% respectively. There was a 9-month primary patency rate of 96.4%. Two patients had device nonsuccess; one was due to delivery balloon rupture and the other the stent dislodged from the balloon, was removed, and replaced with another stent.
The iCAST balloon-expandable stent was found to be a safe and effective treatment for iliac atherosclerotic lesions with satisfactory 9-month primary patency and sustained clinical improvement with low TLR up to three years.
While studies funded by device companies must be taken with a grain of salt, the iCARUS data shows promising clinical performance up to three years post intervention. It does not have ultrasound or angiographic imaging past 9 months which somewhat confounds the information as patients could have developed in stent stenosis or occlusion while developing collateral vessels. Of note, the baseline ABI of 0.73 seemed relatively high, perhaps indicating that the patients within the study already had a fair degree of collateralization, which may mask late stenosis of the stent.
Other studies such as the COBEST trial compared the iCAST stent (marketed as Advanta V12 outside of the US) to bare metal stents for TASC C and D lesions and demonstrated superiority in patency and clinical outcomes. The forthcoming DISCOVER trial which randomizes covered and uncovered balloon-expandable stent use in the CIA will should allow direct comparison of the iCAST to uncovered stents, further clarifying its use in clinical management of CIA and EIA stenosis.
Nicole A. Keefe, MD
Fellow Physician, Interventional Radiology
Department of Radiology and Medical Imaging
University of Virginia