Safety and Performance of the Zeus CC Stent for the Treatment of Iliac Occlusive Disease (EAZY)
This study is currently recruiting participants.
Verified March 2013 by be Medical
Information provided by (Responsible Party):
First received: October 11, 2011
Last updated: March 20, 2013
Last verified: March 2013
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.
Peripheral Artery Disease
||Observational Model: Case-Only
Time Perspective: Prospective
||Endovascular Treatment of Iliac Artery Occlusions or Stenoses Using the Zeus CC Stent System
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2015 (Final data collection date for primary outcome measure)
Patient receiving stent therapy
|Ages Eligible for Study:
||18 Years and older
|Genders 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499329
|AZ Sint Jan Bruges
|Bruges, Belgium |
||Jan De Letter, MD
||AZ Sint Jan Bruges
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 11, 2011
||March 20, 2013
||Belgium: Ethics Committee
Keywords provided by be Medical:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 10, 2013
Peripheral Arterial Disease
Arterial Occlusive Diseases
Peripheral Vascular Diseases