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

Korea University

Status: Completed

Conditions: Critical Limb Ischemia; Infrapopliteal Arterial Occlusive Disease

Treatments: Device: balloon angioplasty; Device: self-expanding nitinol stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01644487

EV-10302

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Primary stenting

Experimental group

Description:

A group of patients who will undergo subsequent primary stenting following successful conventional balloon angioplasty

Treatment:

Device: self-expanding nitinol stent

Balloon only

Active Comparator group

Description:

A group of patients who will undergo routine conventional balloon angioplasty alone without stenting

Treatment:

Device: balloon angioplasty