Peripheral Artery Disease
Conditions
Keywords
Stent therapy
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.
Interventions
None listed
Sponsors
be Medical
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binary (≥ 50%) restenosis rate | 12, 24 months | assessed by duplex ultrasound at the target lesion without the need for repeat TLR after the index-procedure in surviving patients with preserved limbs |
Countries
Belgium
Contacts
Primary ContactJan De Letter, MD
Outcome results
None listed