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

Study Overview

• Status: Completed
• Conditions: Critical Limb Ischemia; Infrapopliteal Arterial Occlusive Disease
• Intervention / Treatment: Device: self-expanding nitinol stent; Device: balloon angioplasty

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 152-703
    • Korea University Guro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primary stenting; A group of patients who will undergo subsequent primary stenting following successful conventional balloon angioplasty	Device: self-expanding nitinol stent; A group of patients who will undergo subsequent primary stenting following successful conventional balloon angioplasty; Other Names: Xpert stent
Active Comparator: Balloon only; A group of patients who will undergo routine conventional balloon angioplasty alone without stenting	Device: balloon angioplasty; A group of patients who will undergo routine conventional balloon angioplasty alone without stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Angiographic binary restenosis rate	12 months

Collaborators and Investigators

• Sponsor: Korea University Guro Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): September 6, 2016
• Study Completion (Actual): October 10, 2018

Study Registration Dates

• First Submitted: July 17, 2012
• First Submitted That Met QC Criteria: July 17, 2012
• First Posted (Estimate): July 19, 2012

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Ischemia; Arterial Occlusive Diseases
• Other Study ID Numbers: EV-10302