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

Not Applicable

Completed

• Conditions: Atherosclerosis; Peripheral Artery Disease
• Interventions: Device: Balloon expandable stent; Device: Self expandable stent

• Registration Number: NCT01834495
• Lead Sponsor: Korea University Guro Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2012-05-08
• Study Start: 2012-10-28
• Study First Submitted QC: 2013-04-15
• Study First Posted: 2013-04-18
• Primary Completion: 2018-01-31
• Status Verified: 2018-08
• Study Completion: 2019-02-11
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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

3. Anatomical criteria:

4. Target lesion length ≥ 4 cm by angiographic estimation,

5. Stenosis of more than 50% or occlusion of the ipsilateral iliac artery,

6. Patent (≤50% stenosis) ipsilateral femoropopliteal artery or concomitantly treatable ipsilateral femoropopliteal lesions (≤30% residual stenosis),

7. At least one patent (less than 50% stenosed) tibioperoneal runoff vessel.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balloon expandable stent	Balloon expandable stent	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
Self expandable stent	Self expandable stent	same to Balloon expandable stent

Primary Outcome Measures

Name	Time	Method
Primary patency rate	1year	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

Secondary Outcome Measures

Name	Time	Method
Angiographic outcome	1 year	Incidence of geographic miss
Clinical outcome	1 year	Repeated target extremity revascularization (TER) rate

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of