Iliac artery occlusive disease Circulatory System Arterial occlusion
Conditions
Interventions
V12 covered stent versus bare stents.
Runoff vessels:
The superficial and deep femoral arteries are the runoff vessels for iliac artery procedures, and the tibial arte
Sponsors
Atrium Australia (Australia)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison, between the two treatment groups (V12 covered stent versus bare stents) of: 1. Primary patency 2. Assisted primary patency | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives: 1. Any amputation above the ankle 2. Ankle Brachial Index (ABI) changes from baseline | — |
Countries
Australia
Outcome results
None listed