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

Primary Purpose

Critical Limb Ischemia, Infrapopliteal Arterial Occlusive Disease

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
self-expanding nitinol stent
balloon angioplasty
Sponsored by
Korea University Guro Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Limb Ischemia

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Korea University Guro Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Primary stenting

Balloon only

Arm Description

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

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

Outcomes

Primary Outcome Measures

Angiographic binary restenosis rate

Secondary Outcome Measures

Full Information

First Posted
July 17, 2012
Last Updated
August 12, 2019
Sponsor
Korea University Guro Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01644487
Brief Title
Self-Expanding Nitinol Stent Versus Balloon Angioplasty Alone for the Below The Knee Arteries(SENS-BTK)
Acronym
SENS-BTK
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 6, 2016 (Actual)
Study Completion Date
October 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Guro Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia, Infrapopliteal Arterial Occlusive Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Provisional stenting with SMART(n=173), Provisional stenting with Complete SE(n=173)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primary stenting
Arm Type
Experimental
Arm Description
A group of patients who will undergo subsequent primary stenting following successful conventional balloon angioplasty
Arm Title
Balloon only
Arm Type
Active Comparator
Arm Description
A group of patients who will undergo routine conventional balloon angioplasty alone without stenting
Intervention Type
Device
Intervention Name(s)
self-expanding nitinol stent
Other Intervention Name(s)
Xpert stent
Intervention Description
A group of patients who will undergo subsequent primary stenting following successful conventional balloon angioplasty
Intervention Type
Device
Intervention Name(s)
balloon angioplasty
Intervention Description
A group of patients who will undergo routine conventional balloon angioplasty alone without stenting
Primary Outcome Measure Information:
Title
Angiographic binary restenosis rate
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of

12. IPD Sharing Statement

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

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