DISCOVER: Dutch Iliac Stent trial: COVERed balloon-expandable versus uncovered balloon-expandable stents. A prospective, randomized, controlled, triple-blind, multi-center trial comparing PTFE-covered balloon-expandable stents versus uncovered balloon-expandable stents in patients with advanced occlusive disease of the common iliac artery in terms of morphologic, clinical, and hemodynamic outcome after a 2-year follow-up.
- Conditions
- arteriosclerosis of the legPeripheral Arterial Occlusive Disease (PAOD)10003216
- Registration Number
- NL-OMON41499
- Lead Sponsor
- Maasstadziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 174
- Age over 18
- Symptomatic, atherosclerotic lesion of the common iliac artery, either a hemodynamically significant stenosis with a length of more than 3 cm, or an occlusion
- Signed informed consent form
- Stenosis with a length of less than 3 cm
- Presence of a metastatic malignancy, or other disease that limits life expectancy to less than two years.
- Previous endovascular or surgical treatment of the common iliac artery on the affected side.
- Inability or unwillingness to comply with the follow-up schedule.
- Mental disability or language barrier that hinders the ability to understand and comply with the informed consent.
- Pregnancy or breast-feeding.
- Severe renal failure (e-GFR <30 mL/min/1.73 m2)
- Known allergy to iodinated contrast agents or to PTFE.
- Contra-indication for anti-coagulation.
- Acute limb ischemia
- Occlusion of the abdominal aorta
- Aneurysm of the abdominal aorta that is not amenable to endograft placement
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method