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Trial record 1 of 3 for:    LUTONIX BTK
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Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by C. R. Bard
Sponsor:
Collaborator:
Bard Ltd
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT01870401
First received: May 7, 2013
Last updated: March 23, 2017
Last verified: March 2017

May 7, 2013
March 23, 2017
May 2013
December 2017   (Final data collection date for primary outcome measure)
  • Freedom from BTK MALE+POD [ Time Frame: 30 days ]
    Composite of all-cause death, above-ankle amputation or major reintervention
  • Limb Salvage [ Time Frame: 6 months ]
    Freedom from the composite of above ankle amputation
  • Primary Patency [ Time Frame: 6 months ]
    Freedom from target vessel occlusion and clinically driven target lesion reintervention
  • Freedom from BTK MALE+POD [ Time Frame: 30 days ]
    Composite of all-cause death, above-ankle amputation or major reintervention
  • Limb Salvage [ Time Frame: 12 months ]
    Freedom from the composite of above ankle amputation
  • Primary Patency [ Time Frame: 12 months ]
    Freedom from target vessel occlusion and clinically driven target lesion reintervention
Complete list of historical versions of study NCT01870401 on ClinicalTrials.gov Archive Site
  • Wound healing [ Time Frame: 30 days; 6 months, 12 months, 24 months, and 36 months ]
    Healed or not, if not, improving, stagnant, worsening
  • Primary Patency [ Time Frame: 30 days and at 6 months, 12 months, 24 months, and 36 months ]
    Freedom from occlusion without clinically-driven Target Lesion Revascularization (TLR)
  • Hemodynamic outcome [ Time Frame: 30 days and at 6 months, 12 months, 24 months, and 36 months ]
    change in toe & ankle pressures
  • Clinically-driven TLR [ Time Frame: 30 days and at 6, 12, 24, and 36 months ]
    Revascularization performed on all randomized patients who returned with clinical symptoms, and if the subject has a target lesion diameter stenosis ≥ 50%.
  • Limb salvage in surviving subjects [ Time Frame: 30 days and at 6, 12, 24, and 36 months ]
    No Amputation of target limb
  • Wound healing [ Time Frame: 30 days; 6 months, 12 months, 24 months, and 36 months ]
    Healed or not, if not, improving, stagnant, worsening
  • Primary Patency [ Time Frame: 30 days and at 6 months, 12 months, 24 months, and 36 months ]
    Freedom from occlusion without clinically-driven Target Lesion Revascularization (TLR)
  • Hemodynamic outcome [ Time Frame: 30 days and at 6 months, 12 months, 24 months, and 36 months ]
    change in toe & ankle pressures
  • Clinically-driven TLR [ Time Frame: 30 days and at 6, 12, 24, 36, 48 and 60 months ]
    Revascularization performed on all randomized patients who returned with clinical symptoms, and if the subject has a target lesion diameter stenosis ≥ 50%.
  • Limb salvage in surviving subjects [ Time Frame: 30 days and at 6, 12, 24, 36, 48 and 60 months ]
    No Amputation of target limb
Not Provided
Not Provided
 
Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Lutonix Drug Coated Balloon Versus Standard Balloon Angioplasty for Treatment of Below-the-Knee (BTK) Arteries(Lutonix BTK Trial)
To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of stenosis or occlusion of native below-the-knee arteries.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Treatment
Critical Limb Ischemia
  • Device: Lutonix DCB
    Other Name: LTX DCB
  • Device: Uncoated PTA Catheter
    Other Name: PTA
  • Experimental: Lutonix DCB
    Lutonix Paclitaxel Drug Coated Balloon
    Intervention: Device: Lutonix DCB
  • Active Comparator: PTA Catheter
    Standard Uncoated PTA Catheter
    Intervention: Device: Uncoated PTA Catheter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
June 2020
December 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or non-pregnant female ≥18 years of age;
  • Rutherford Clinical Category 3, 4 & 5;
  • Life expectancy ≥ 1 year;
  • Significant stenosis (≥70%)
  • A patent inflow artery;
  • Target vessel(s) diameter between 2 and 4 mm;
  • Target vessel(s) reconstitute(s) at or above the ankle

Exclusion Criteria:

  • Pregnant or planning on becoming pregnant;
  • History of stroke within 3 months;
  • History of MI, thrombolysis or angina within 30 days of enrollment;
  • Planned major amputation (of either leg)
  • Prior major amputation if amputation occurred less than one year prior to enrollment and if patient is not independently ambulating;
  • GFR ≤ 30 ml/min per 1.73m2;
  • Acute limb ischemia;
  • In-stent restenosis of target lesion
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Kelly Erickson kelly.erickson@crbard.com
United States,   Austria,   Belgium,   Canada,   Germany,   Italy,   Japan,   Switzerland
 
 
NCT01870401
CL0005-01
Yes
Not Provided
Not Provided
Not Provided
C. R. Bard
C. R. Bard
Bard Ltd
Principal Investigator: Patrick Geraghty, MD Washington University School of Medicine
Principal Investigator: Jihad Mustapha, MD Metro Health Hospital
Principal Investigator: Marianne Brodmann, MD Medical University Graz, Austria
C. R. Bard
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP