Status:
UNKNOWN
Safety and Performance of the Zeus CC Stent for the Treatment of Iliac Occlusive Disease
Lead Sponsor:
be Medical
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
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 ili...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01499329
Start Date
December 1 2011
End Date
December 1 2015
Last Update
July 16 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
AZ Sint Jan Bruges
Bruges, Belgium