NL-OMON41499
Completed
Not Applicable
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. - Covered versus uncovered balloon-expandable iliac stents.
Maasstadziekenhuis0 sites174 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- arteriosclerosis of the leg
- Sponsor
- Maasstadziekenhuis
- Enrollment
- 174
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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