Status:
COMPLETED
Efficacy of Balloon-Expandable Stent Versus Self-Expandable Stent for the Atherosclerotic ILIAC Arterial Disease
Lead Sponsor:
Korea University Guro Hospital
Conditions:
Peripheral Artery Disease
Atherosclerosis
Eligibility:
All Genders
20-85 years
Phase:
NA
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 ather...
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 TransAt...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 28 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2019
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT01834495
Start Date
October 28 2012
End Date
February 11 2019
Last Update
August 14 2019
Active Locations (1)
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1
Korea University Guro Hospital
Seoul, South Korea, 152-703