Clinical trial NCT01499329: Safety and Performance of the Zeus CC Stent for the Treatment of Iliac Occlusive Disease
Official title: Endovascular Treatment of Iliac Artery Occlusions or Stenoses Using the Zeus CC Stent System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Artery Disease
Keywords: Stent therapy
Lead sponsor: be Medical
Sponsor class: INDUSTRY
First posted: 2011-12-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with iliac occlusive disease TASC A, B, C and D lesions.

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 iliac lesions.


Eligibility criteria: Inclusion Criteria:

1. Patient is older than 18 years
2. Patient must sign a written informed consent form that is approved by the ethics committee prior to index-procedure
3. Patient must be compliant with all follow-up visits
4. Patient suffers from intermittent claudication (Rutherford 1-3) or critical limb ischemia (Rutherford 4 and 5)
5. Patient's life expectancy is more than 2 years
6. Patient has iliac atherosclerotic de novo lesion(s) type A, B, C \& D according to TASC-II classification
7. Target vessel diameter is between 5 and 9 mm
8. Target lesion has a baseline diameter stenosis of more than 50%
9. Patient has sufficient infra-inguinal run-off with at least a patent common femoral artery and deep femoral artery (both \<50% stenosis)

Exclusion Criteria:

1. Patient has a life expectancy of less than 2 years
2. Patient is refusing to be compliant with all follow-up visits
3. Patient suffers from acute limb ischemia, defined as any sudden decrease in limb perfusion causing a potential threat to limb viability.
4. Patient is intolerant to anticoagulant or antiplatelet therapy such as aspirin, heparin, clopidogrel or ticlopidine drug therapy
5. Patient has already been treated with a stent in the ipsilateral target vessel
6. Patient suffered tissue loss in the target extremities, defined as Rutherford 6
7. Patient is already enrolled in this or another investigational device study
8. 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
9. Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index-procedure
10. Any planned surgical intervention within 30 days of the index-procedure
11. Patient has an abdominal aortic aneurysm that is likely to require repair within the next 2 years.
12. 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.
13. Target lesion is a restenotic lesion.
14. Target lesion is adjacent an aneurysm.
15. Target vessel perforation with documented contrast extravasation during index-procedure prior to stent placement.

Primary outcomes:
measure: Binary (≥ 50%) restenosis rate
timeFrame: 12, 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bruges
country: Belgium
facility: AZ Sint Jan Bruges
Study officials:
affiliation: AZ Sint Jan Bruges
name: Jan De Letter, MD
role: PRINCIPAL_INVESTIGATOR
References: