Vascular Lesions
Conditions
Keywords
Common Iliac Artery and External Iliac Artery
Brief summary
The objective of this prospective, randomized,controlled and multicenter trial is, to compare recurrent-restenosis rates in the balloon expandable VISIO-PRO stent arm and the selfexpandable PROTEGE GPS stent arm 12 month after treatment of stenosis or occlusions of common and external iliac artery disease.
Interventions
DEVICEPROTEGE GPS stent vs. VISI-PRO stent
Visi-Pro balloon expandable stent vs. PROTEGE GPS selfexpanding nitinol stent to treat stenosis or occlusion of common and external iliac artery disease
Sponsors
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 21 years. 2. Patient must sign informed consent form. 3. Patient must agree to participate in the study and comply with follow-up requirements. 4. Clinically, all patients must be in Rutherford category 1 to 4. Angiographic Inclusion Criteria: 5. Planned stenting (degree of stenosis 70-100%) within the common or external iliac artery. The target lesion must not extend beyond the iliac arteries. 6. Lesion segment starts at the aortic bifurcation and ends at the take off of the common femoral artery (Offset of the iliac circumflex artery beneath the ligamentum inguinale). 7. The length of the lesion should be at least 1 cm and maximally 20 cm (measurement by radiopaque ruler). 8. The degree of target lesion stenosis must be determined by pre-interventional duplex ultrasound or (MR-) angiography. 9. Patency of ipsilateral profunda artery. Ipsi- or contralateral artery lesions of the leg can be treated prior to the treatment of the study lesion. 10. In cases of two or more stenotic regions within the segment, these are considered separate lesions if there is a nonstenotic or only mildly stenotic (\< 30%) segment of at least 2 cm in length between them. Otherwise, they are considered as single lesion. In case of separate lesions, only the proximal lesion will be taken as the target lesion! 11. A tandem lesion that can be treated with one stent will be considered as one lesion.
Exclusion criteria
1. Patient is currently participating in another clinical trial 2. Pregnancy or pregnancy planned during study duration 3. Life expectancy less than 2 years 4. Co-morbidities preventing study participation 5. Severe coagulation disorders 6. Current treatment with anticoagulants other than aspirin, ticlopidine, clopidogrel or prasugrel. 7. Active gastric ulcer or gastrointestinal bleeding 8. Thrombotic occlusion of the target vessel within previous 4 weeks. 9. Treatment of target lesion with laser or atherectomy devices. 10. Dialysis dependency. 11. Manifest hyperthyreosis. 12. Known allergy against contrast agent that cannot be adequately controlled by usual premedication. 13. Known heparin intolerance. 14. Known paclitaxel intolerance. Angiographic: 15. Target lesion extends into the femoral artery. 16. Symptomatic untreated inflow lesion \> 70% in ipsilateral iliac arteries. Pretreatment of iliac stenosis is possible. 17. Target Lesion is in aortic bifurcation and needs treatment with kissing balloon technique 18. Lesion in abdominal aorta that needs treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duplex-ultrasound determined recurrent restenosis after 12 month | 12 month | Duplex-ultrasound definition: = recurrent stenosis ≥ 70% in relation to vessel diameter or PSV \>3.4 per duplex ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of ABI of at least o.1 points in treated leg after 6 and 12 month (AHA Guidlines) | 6 and 12 month | — |
| Clinically driven target lesion revascularization (TLR and TVR) at 6 and 12 month | at 6 and 12 month | TLR = Target Lesion Revascularisation TVR = Target Vessel Revascularisation |
| Recurrent stenosis >= 70%within the stent at 6 and 12 month | at 6 and 12 month | — |
| Clinical improvement of walking distance and improvement of at least 1 Rutherford category | 12 and 24 month | Clinical improvement of walking distance and improvement of at least 1 Rutherford category |
| Primary angiographic success rate (<30% residual stenosis) | Procedure | — |
| Major adverse vascular events plus death rate | 24 month | Major adverse vascular events plus death rate |
| Clinical and hemodynamic parameters (walking distance, ABI, Rutherford category) at 1, 6 and 12 month | at 1, 6 and 12 month | — |
Countries
Germany
Outcome results
None listed