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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01644487
Recruitment Status : Active, not recruiting
First Posted : July 19, 2012
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Critical Limb Ischemia Infrapopliteal Arterial Occlusive Disease Device: self-expanding nitinol stent Device: balloon angioplasty

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Provisional stenting with SMART(n=173), Provisional stenting with Complete SE(n=173)
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2012
Primary Completion Date : September 6, 2016
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
U.S. FDA Resources

Arms and Interventions

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 Name: 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


Outcome Measures

Primary Outcome Measures :
  1. Angiographic binary restenosis rate [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01644487


Locations
Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of, 152-703
Sponsors and Collaborators
Korea University Guro Hospital
More Information

Responsible Party: Seung Woon Rha, Professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier: NCT01644487     History of Changes
Other Study ID Numbers: EV-10302
First Posted: July 19, 2012    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Ischemia
Arterial Occlusive Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases