Self-Expanding Nitinol Stent Versus Balloon Angioplasty Alone for the Below The Knee Arteries(SENS-BTK)

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)

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.

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