COvered Balloon Expandable Stent Trial

Atrium Australia (Australia)0 sites125 target enrollmentFebruary 28, 2006

Overview

2011 Results article in https://pubmed.ncbi.nlm.nih.gov/21906903/ (added 06/08/2021)

Registry

who.int

Start Date

February 28, 2006

End Date

August 30, 2007

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

Atrium Australia (Australia)

•1\. Informed consent obtained
•2\. Patient aged 18 years or over and under 80 years
•3\. Patients with TransAtlantic Society Consensus (TASC) type B, C and D lesions
•4\. Haemodynamically significant dissections after angioplasty
•5\. Haemodynamically significant recurrent stenosis after angioplasty

•1\. Life expectancy of less than 12 months
•2\. Patients with uncontrolled hypertension
•3\. Patient with TASC type A lesion
•4\. Pregnant women or women of childbearing potential who are not following an effective method of contraception
•5\. Prior enrolment in this trial, patients who had any procedure performed at the aortoiliac level
•6\. Patients with extensive common femoral artery disease or who have had multiple groin procedures
•7\. Contradiction to aspirin or clopidogrel usage
•8\. Patients with superficial and profunda femoral arteries occluded
•9\. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study, or language barrier such that the subject being unable to give informed consent
•10\. Uncooperative attitude or potential for non\-compliance with the requirements of the protocol making study participation impractical