Efficacy of Balloon-Expandable Stent Versus Self-Expandable Stent for the Atherosclerotic ILIAC Arterial Disease

Study Overview
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Brief Summary
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The purpose of the investigators study is to examine and compare primary patency between balloon expandable cobalt chromium stent and self expandable nitinol stents (SCUBA versus COMPLETE-SE) in atherosclerotic iliac artery lesion.

Detailed Description
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Obstructive atherosclerotic disease of the distal aorta and iliac arteries is preferentially treated with endovascular techniques, and an endovascular-first strategy can be recommended for all TransAtlantic Inter-Society Consensus (TASC) A-C lesions. Low morbidity and mortality as well as a >90% technical success rate justify the endovascular-first approach. Currently, In an attempt to improve outcomes, stent use has increased, and a number of studies favor iliac stenting over simple Percutaneous Transluminal Angioplasty (PTA). A meta-analysis comparing iliac stenting to Percutaneous Transluminal Angioplasty (PTA) found that stenting had higher rates of technical success and was associated with a 39% reduction in the risk of long-term loss of patency. However, randomized control trial for comparison of primary patency between balloon expandable stent and self expandable stent has not been done, although there were some trials in that primary patency was compared among balloon expandable stents or among self expandable stents. Currently, The choice of balloon versus self expandable stents is determined mainly by operator preference. The main advantages of balloon expandable stents are the higher radial stiffness and the more accurate placement, which is especially important in bifurcation lesions. In the external iliac artery, a primary stenting strategy using self-expandable stents compared with provisional stenting is preferred mainly due to a lower risk of dissection and elastic recoil. Thus, the purpose of our study is to examine and compare primary patency between balloon expandable stent and self expandable stent(SCUBA versus COMPLETE SE stent)

Official Title
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Phase 4 Study of Efficacy of Balloon-Expandable Cobalt Chromium SCUBA Stent Versus Self-Expandable Stent COMPLETE-SE Nitinol Stenting for the Atherosclerotic ILIAC Arterial Disease: Prospective, Multicenter, Randomized, Controlled Trial

Conditions
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Peripheral Artery Disease, Atherosclerosis

Intervention / Treatment
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* Device: Balloon expandable stent
* Device: Self expandable stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Clinical criteria: symptomatic peripheral-artery disease with moderate to severe claudication (Rutherford 2-3), chronic critical limb ischemia with pain while was at rest (Rutherford 4), or chronic critical limb ischemia with ischemic ulcers (Rutherford 5-6) Patients with signed informed consent 2. Anatomical criteria: Target lesion length ≥ 4 cm by angiographic estimation, Stenosis of more than 50% or occlusion of the ipsilateral iliac artery, Patent (≤50% stenosis) ipsilateral femoropopliteal artery or concomitantly treatable ipsilateral femoropopliteal lesions (≤30% residual stenosis), At least one patent (less than 50% stenosed) tibioperoneal runoff vessel. Exclusion Criteria: Disagree with written informed consent Major bleeding history within prior 2 months Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel or contrast agent Acute limb ischemia Untreated inflow disease of the distal aorta (more than 50 percent stenosis or occlusion) Patients that major amputation (above the ankle amputation) has been done, is planned or required Patients with life expectancy <1 year due to comorbidity Age > 85 years

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 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 |
| --- | --- |
| Experimental: Balloon expandable stent<br>study design is 1:1 randomization design. Patients will be randomized in a 1:1 manner according to different two (balloon expandable versus Self expandable)stents. Randomization procedure will be performed using a web-based program | Device: Balloon expandable stent<br>* provisional stenting should be performed; the case that optimal ballooning response in not obtained should be enrolled. Optimal balloon response is defined as a residual pressure gradient of > 15mmHg, residual stenosis of >30% and flow limiting dissection<br>* Other names: SCUBA stent;|
| Active Comparator: Self expandable stent<br>same to Balloon expandable stent | Device: Self expandable stent<br>* provisional stenting should be performed; the case that optimal ballooning response in not obtained should be enrolled. Optimal balloon response is defined as a residual pressure gradient of > 15mmHg, residual stenosis of >30% and flow limiting dissection<br>* Other names: COMPLETE SE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency rate | stenosis of at least 50 percent of the luminal diameter in the treated segment 12 months after intervention, as determined by quantitative angiography or CT angiography or peak systolic velocity ratio >2.5 by duplex sonography according to the stent type | 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome | Limb salvage (free of above-the-ankle amputation) | 1 year | 
| Clinical outcome | Sustained clinical improvement rate at 12 month follow-up | 1 year | 
| Clinical outcome | Ankle-brachial index (ABI) at 12 months | 1 year | 
| Clinical outcome | The rate of major adverse cardiovascular events (MACE) at 12 months | 1 year | 
| Clinical outcome | Repeated target lesion revascularization (TLR) rate | 1year | 
| Angiographic outcome | Stent fracture rate | 1 year | 
| Angiographic outcome | Incidence of geographic miss | 1 year | 
| Clinical outcome | Repeated target extremity revascularization (TER) rate | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral artery disease, atherosclerosis, stent