Iliac, Common and External (ICE) Artery Stent Trial

Study Overview
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Brief Summary
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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.

Official Title
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Balloon Expandable vs. Selfexpanding Stents to Treat Stenosis or Occlusions of Common and External Iliac Artery Disease

Conditions
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Vascular Lesions

Intervention / Treatment
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* Device: PROTEGE GPS stent vs. VISI-PRO stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 21 years. Patient must sign informed consent form. Patient must agree to participate in the study and comply with follow-up requirements. Clinically, all patients must be in Rutherford category 1 to 4. Angiographic Inclusion Criteria: Planned stenting (degree of stenosis 70-100%) within the common or external iliac artery. The target lesion must not extend beyond the iliac arteries. 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). The length of the lesion should be at least 1 cm and maximally 20 cm (measurement by radiopaque ruler). The degree of target lesion stenosis must be determined by pre-interventional duplex ultrasound or (MR-) angiography. Patency of ipsilateral profunda artery. Ipsi- or contralateral artery lesions of the leg can be treated prior to the treatment of the study lesion. 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! A tandem lesion that can be treated with one stent will be considered as one lesion. Exclusion Criteria: Patient is currently participating in another clinical trial Pregnancy or pregnancy planned during study duration Life expectancy less than 2 years Co-morbidities preventing study participation Severe coagulation disorders Current treatment with anticoagulants other than aspirin, ticlopidine, clopidogrel or prasugrel. Active gastric ulcer or gastrointestinal bleeding Thrombotic occlusion of the target vessel within previous 4 weeks. Treatment of target lesion with laser or atherectomy devices. Dialysis dependency. Manifest hyperthyreosis. Known allergy against contrast agent that cannot be adequately controlled by usual premedication. Known heparin intolerance. Known paclitaxel intolerance. Angiographic: Target lesion extends into the femoral artery. Symptomatic untreated inflow lesion > 70% in ipsilateral iliac arteries. Pretreatment of iliac stenosis is possible. Target Lesion is in aortic bifurcation and needs treatment with kissing balloon technique Lesion in abdominal aorta that needs treatment.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Balloon expandable stent arm<br>First placement of the sheath and successful passage of a 0.018 or 0.035 guidewire via the sheath across the target lesion in the iliac arteries was required. Consecutively the balloon-expandable stent (Visi-Pro™, ev3 Endovascular, Inc., Plymouth, MN, USA), which was premounted on a balloon catheter, was deployed by inflation of the balloon. The nominal stent diameter had to approximate the reference vessel diameter of the target lesion. Postdilation was permitted | Device: PROTEGE GPS stent vs. VISI-PRO stent<br>* Visi-Pro balloon expandable stent vs. PROTEGE GPS selfexpanding nitinol stent to treat stenosis or occlusion of common and external iliac artery disease<br>* Other names: PAOD;|
| Active Comparator: Selfexpanding stent arm<br>First placement of the sheath and successful passage of a 0.018 or 0.035 guidewire via the sheath across the target lesion in the iliac arteries was required. Consecutively the the self-expanding stent (Protege™, ev3 Endovascular, Inc., Plymouth, MN, USA), which had to exceed in the nominal diameter the reference vessel diameter at least by 1 mm, was released. Postdilation was mandatory. The inflated postdilation-balloon should approximate the reference vessel diameter. | Device: PROTEGE GPS stent vs. VISI-PRO stent<br>* Visi-Pro balloon expandable stent vs. PROTEGE GPS selfexpanding nitinol stent to treat stenosis or occlusion of common and external iliac artery disease<br>* Other names: PAOD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duplex-ultrasound determined recurrent restenosis after 12 month | Duplex-ultrasound definition: = recurrent stenosis ≥ 70% in relation to vessel diameter or PSV >3.4 per duplex ultrasound | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement of walking distance and improvement of at least 1 Rutherford category | Clinical improvement of walking distance and improvement of at least 1 Rutherford category | 12 and 24 month | 
| 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 | TLR = Target Lesion Revascularisation TVR = Target Vessel Revascularisation | at 6 and 12 month | 
| Recurrent stenosis >= 70%within the stent at 6 and 12 month |  | at 6 and 12 month | 
| Clinical and hemodynamic parameters (walking distance, ABI, Rutherford category) at 1, 6 and 12 month |  | at 1, 6 and 12 month | 
| Primary angiographic success rate (<30% residual stenosis) |  | Procedure | 
| Major adverse vascular events plus death rate | Major adverse vascular events plus death rate | 24 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Common Iliac Artery and External Iliac Artery