Efficacy of Self-Expanding Nitinol Stent Versus Balloon Angioplasty Alone for the Below The Knee Arteries Following Successful Balloon Angioplasty Trial (Korean Vascular Intervention Multicenter Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Angiographic binary restenosis rate
Study Overview
Brief Summary
The objectives of this study are to compare directly conventional balloon angioplasty alone versus. balloon angioplasty with routine stenting - that is, to determine whether angioplasty with self-expanding stent is superior to conventional balloon angioplasty - in the infrapopliteal arterial occlusive lesions of critical limb ischemia patients by collecting and analyzing the cases of each patient group in a prospective multicenter randomized clinical trial, and to clarify main factors affecting mid- and long-term clinical effects of angioplasty with self-expanding stent in the infrapopliteal arteries.
Hypothesis: Balloon PTA followed by routine stenting with self-expanding nitinol stent in critical limb ischemia patients with infrapopliteal arterial occlusive lesions is superior to conventional PTA in the aspect of vascular restenosis rate.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Symptomatic critical limb ischemia (Rutherford 4 - 6)
- •Patients with signed informed consent
- •Target lesion length < 8 cm by angiographic estimation
- •Stenosis of >50% or occlusive atherosclerotic lesion of the ipsilateral infrapopliteal artery
- •Reference vessel diameter should be 2.0-4.5 mm
Exclusion Criteria
- •Patient has a known allergy to heparin, aspirin, or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies
- •Patient takes warfarin
- •Patient has a history of previous life-threatening contrast media reaction
- •Patient is currently enrolled in another investigational device or drug trial
- •Patient is currently breast-feeding, is pregnant, or intends to become pregnant
- •Patient is mentally ill or retarded
- •Acute critical limb ischemia
- •Major bleeding history within prior 2 months
- •Severe hepatic dysfunction (> 3 times normal reference values)
- •Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
- •Life expectancy <1 year due to comorbidity
- •Reference segment diameter is not suitable for available stent design
- •Previously implanted stent(s) or PTA at the same lesion site
- •Inflow-limiting arterial lesions left untreated
Arms & Interventions
Balloon only
A group of patients who will undergo routine conventional balloon angioplasty alone without stenting
Intervention: balloon angioplasty (Device)
Primary stenting
A group of patients who will undergo subsequent primary stenting following successful conventional balloon angioplasty
Intervention: self-expanding nitinol stent (Device)
Outcomes
Primary Outcomes
Angiographic binary restenosis rate
Time Frame: 12 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Seung Woon Rha
Professor
Korea University Guro Hospital