COvered Balloon Expandable Stent Trial

Not Applicable

Completed

• Conditions: Iliac artery occlusive disease; Circulatory System; Arterial occlusion

• Registration Number: ISRCTN89458845
• Lead Sponsor: Atrium Australia (Australia)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-02-28
• Study Completion: 2007-08-30
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

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

Exclusion Criteria

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

N.B. In patients with a plasma/serum creatinine of more than 250 - 300 µmol/L, iodinated contrast is contraindicated and should be avoided.

Study & Design

• Study Type: Interventional
• Study Design: Not specified