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

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.

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Key information

Conditions

Critical Limb Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Infrapopliteal Arterial Occlusive Disease Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea University Guro Hospital

Seoul, 152-703, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

self-expanding nitinol stent

Device

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

Other names: Xpert stent

Balloon Angioplasty

Device

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

Primary outcomes

Angiographic binary restenosis rate

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Korea University Guro Hospital

Other

Registry information

Official study title

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)

Acronym: SENS-BTK

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2018
First posted: Jul 19, 2012
Registry last updated: Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed