Atrium’s iCast Covered Stent in Iliac Treatment Supported by iCARUS Study
October 11, 2012—Results from iCARUS (iCast Atrium Registry Ultrasound Study) were presented by John R. Laird, MD, at the VIVA 2012: Vascular InterVentional Advances meeting in Las Vegas. The iCARUS pivotal study evaluated the safety and efficacy of the iCast balloon-expandable covered stent (Atrium Medical Corporation, Hudson, NH) for treating iliac artery stenoses in patients with de novo or restenotic lesions in the common and/or external iliac arteries.
Conducted under an investigational device exemption, this prospective, single-arm study enrolled 165 patients at 25 sites and compared the Atrium iCast stent to a performance metric based on the results of other US Food and Drug Administration-approved iliac bare-metal stents in patients with symptomatic atherosclerotic lesions in the common and/or external iliac arteries.
The primary endpoint was a composite endpoint of the occurrence of death within 30 days, target site revascularization within 9 months, or restenosis detected on duplex ultrasound of the iliac artery (or angiography done in lieu of ultrasound) at 9 months postprocedure. The clinical status of the patient was assessed with the Fontaine classification at baseline, 6 to 12 weeks after the procedure, and at the last clinical follow-up.
The results showed that the composite endpoint rate at 9 months was 8.1%, which was significantly lower than the performance metric of 16.6%; therefore, the trial met its primary endpoint. There were no deaths within 30 days. The target lesion revascularization rate within 9 months was 2.9%. Analysis of key prespecified endpoints of the iCARUS study is consistent with a low rate of major adverse vascular events and major adverse events, and a high rate of early and late clinical and angiographic success with the use of the Atrium iCast device.
The iCARUS data support the safety and efficacy of the iCast covered stent when used for revascularization of iliac lesions, concluded Dr. Laird.
advertisement
Related Articles
Top 5 Articles From October 2012
The Narrow Distal Aorta
A risk factor for limb occlusion and an anatomic challenge for endograft selection.
By Peter R. Nelson, MD, MS, and Nikhil Kansal, MD
CAS Technology Advancement
The opportunity to improve outcomes with new device approaches.
By Sumaira Macdonald, MBChB (Comm.), FRCP, FRCR, PhD
The Second European Carotid Surgery Trial
The new ECST-2 is a randomized clinical trial that will compare medical therapy alone with CEA or CAS for patients with asymptomatic and symptomatic carotid artery stenosis using a new measure called the Carotid Artery Risk Score.
By Roland L. Featherstone, PhD, and Martin M. Brown, MA, MD, FRCP
The Asymptomatic Carotid Surgery Trial 2
Background and aims of the ACST-2 study.
By Sumaira Macdonald, MBChB (Comm.), FRCP, FRCR, PhD, and Alison W. Halliday, MS, FRCS
Enhancing Carotid Endarterectomy
Like its interventional counterpart, open surgical carotid revascularization has also seen technical improvements, including the mini-incision Jikei method.
By Takao Ohki, MD, PhD
Top 5 from CIToday's Current Issue
The Approval of PFO Closure in the United States
A look back at the long road to FDA approval and the implications on patient care options going forward.
By Marie-France Poulin, MD; and Clifford J. Kavinsky, MD, PhD
The Ambulatory Approach
Answering questions about the shift in cardiology from inpatient to outpatient procedures.
By Anne Beekman, RN
Point/Counterpoint: Does the United States Have Enough TAVR Centers?
By Paul J. Pearson, MD, PhD; and D. Craig Miller, MD
Anticoagulation Management After Watchman Implantation
Current indications for antiplatelet agents and NOACs after Watchman implantation.
