arteriosclerosis of the leg Peripheral Arterial Occlusive Disease (PAOD)
Conditions
Interventions
The control group will undergo endovascular dilatation or revascularization of
the common iliac artery, followed by placement of one or more uncovered
balloon-expandable stents. The study group will
Sponsors
Maasstadziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study parameters/endpoints: The primary endpoints are absence of binary restenosis rate, reocclusion rate and target-lesion revascularization rate. Primary study parameters are age, gender, relevant co-morbidity, and several patient, disease and procedure related parameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are clinical success, procedural success, hemodynamic success, major amputation rate, complication rate and mortality rate. | — |
Countries
Netherlands
Outcome results
None listed