Atherosclerosis Clinical Trial
Official title:
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
Verified date | August 2018 |
Source | Korea University Guro Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 230 |
Est. completion date | February 11, 2019 |
Est. primary completion date | January 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Korea University Guro Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Korea University Guro Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Clinical outcome | Limb salvage (free of above-the-ankle amputation) | 1 year | |
Secondary | Clinical outcome | Sustained clinical improvement rate at 12 month follow-up | 1 year | |
Secondary | Clinical outcome | Ankle-brachial index (ABI) at 12 months | 1 year | |
Secondary | Clinical outcome | The rate of major adverse cardiovascular events (MACE) at 12 months | 1 year | |
Secondary | Clinical outcome | Repeated target lesion revascularization (TLR) rate | 1year | |
Secondary | Angiographic outcome | Stent fracture rate | 1 year | |
Secondary | Angiographic outcome | Incidence of geographic miss | 1 year | |
Secondary | Clinical outcome | Repeated target extremity revascularization (TER) rate | 1 year |
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