Safety and Performance of the Zeus CC Stent for the Treatment of Iliac Occlusive Disease (EAZY)
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ClinicalTrials.gov Identifier: NCT01499329
Recruitment Status : Unknown
Verified July 2015 by be Medical. Recruitment status was: Recruiting
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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with iliac occlusive disease TASC A, B, C and D lesions.
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)
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.