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

Korea University Guro Hospital230 enrolled

Overview

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.

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

230

Conditions

Peripheral Artery Disease Atherosclerosis

Interventions

Balloon expandable stentDEVICE

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

Self expandable stentDEVICE

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1.Clinical criteria: 1. 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) 2. Patients with signed informed consent 2\. Anatomical criteria: 1. Target lesion length ≥ 4 cm by angiographic estimation, 2. Stenosis of more than 50% or occlusion of the ipsilateral iliac artery, 3. Patent (≤50% stenosis) ipsilateral femoropopliteal artery or concomitantly treatable ipsilateral femoropopliteal lesions (≤30% residual stenosis), 4. At least one patent (less than 50% stenosed) tibioperoneal runoff vessel. Exclusion Criteria: 1. Disagree with written informed consent 2. Major bleeding history within prior 2 months 3. Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel or contrast agent 4. Acute limb ischemia 5. Untreated inflow disease of the distal aorta (more than 50 percent stenosis or occlusion) 6. Patients that major amputation ("above the ankle" amputation) has been done, is planned or required 7. Patients with life expectancy \<1 year due to comorbidity 8. Age \> 85 years

Locations (1)

Korea University Guro Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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

Time frame: 1year

Secondary Outcomes

Clinical outcome

Limb salvage (free of above-the-ankle amputation)

Time frame: 1 year

Clinical outcome

Sustained clinical improvement rate at 12 month follow-up

Time frame: 1 year

Clinical outcome

Ankle-brachial index (ABI) at 12 months

Time frame: 1 year

Clinical outcome

The rate of major adverse cardiovascular events (MACE) at 12 months

Time frame: 1 year

Clinical outcome

Repeated target lesion revascularization (TLR) rate

Time frame: 1year

Angiographic outcome

Stent fracture rate

Time frame: 1 year

Angiographic outcome

Incidence of geographic miss

Time frame: 1 year

Clinical outcome

Repeated target extremity revascularization (TER) rate

Data from ClinicalTrials.gov

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