Safety and Performance of the Zeus CC Stent for the Treatment of Iliac Occlusive Disease

Study Overview
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Brief Summary
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The purpose of this study is to evaluate safety and performance of the balloon-expandable Zeus CC (Rontis AG) stent for the treatment of Trans-Atlantic Inter-Society Consensus (TASC) A, B, C and D iliac lesions.

Official Title
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Endovascular Treatment of Iliac Artery Occlusions or Stenoses Using the Zeus CC Stent System

Conditions
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Peripheral Artery Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is older than 18 years Patient must sign a written informed consent form that is approved by the ethics committee prior to index-procedure Patient must be compliant with all follow-up visits Patient suffers from intermittent claudication (Rutherford 1-3) or critical limb ischemia (Rutherford 4 and 5) Patient's life expectancy is more than 2 years Patient has iliac atherosclerotic de novo lesion(s) type A, B, C & D according to TASC-II classification Target vessel diameter is between 5 and 9 mm Target lesion has a baseline diameter stenosis of more than 50% Patient has sufficient infra-inguinal run-off with at least a patent common femoral artery and deep femoral artery (both <50% stenosis) Exclusion Criteria: Patient has a life expectancy of less than 2 years Patient is refusing to be compliant with all follow-up visits Patient suffers from acute limb ischemia, defined as any sudden decrease in limb perfusion causing a potential threat to limb viability. Patient is intolerant to anticoagulant or antiplatelet therapy such as aspirin, heparin, clopidogrel or ticlopidine drug therapy Patient has already been treated with a stent in the ipsilateral target vessel Patient suffered tissue loss in the target extremities, defined as Rutherford 6 Patient is already enrolled in this or another investigational device study Patient had a coronary intervention within the last 60 days before enrolment into this study or there is a planned coronary intervention within 60 days of enrolment into this study Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index-procedure Any planned surgical intervention within 30 days of the index-procedure Patient has an abdominal aortic aneurysm that is likely to require repair within the next 2 years. Patient has no sufficient infra-inguinal run-off (>50% stenosis). Patient inclusion is only possible if revascularization (endovascular or surgical) is performed in the same procedure with a peroperative angiographic control yielding <30% stenosis. Target lesion is a restenotic lesion. Target lesion is adjacent an aneurysm. Target vessel perforation with documented contrast extravasation during index-procedure prior to stent placement.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient receiving stent therapy<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binary (≥ 50%) restenosis rate | assessed by duplex ultrasound at the target lesion without the need for repeat TLR after the index-procedure in surviving patients with preserved limbs | 12, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stent therapy