Trial record 1 of 1 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 May 2014 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: May 30, 2014
Last verified: May 2014

May 7, 2013
May 30, 2014
May 2013
September 2014   (final data collection date for primary outcome measure)
  • Freedom from BTK MALE+POD [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Composite of all-cause death, above-ankle amputation or major reintervention
  • Limb Salvage [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Freedom from the composite of above ankle amputation
  • Primary Patency [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Freedom from target vessel occlusion and clinically driven target lesion reintervention
Same as current
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    change in toe & ankle pressures
  • Clinically-driven TLR [ Time Frame: 30 days and at 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    No Amputation of target limb
Same as current
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
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Balloon Angioplasty 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
480
September 2019
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or non-pregnant female ≥18 years of age;
  • Rutherford Clinical Category 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;
  • Prior or planned major amputation;
  • GFR ≤ 30 ml/min per 1.73m2;
  • Acute limb ischemia;
  • In-stent restenosis of target lesion
Both
18 Years and older
No
Contact: Robert M Jardin LutonixResearch@crbard.com
United States,   Austria,   Belgium,   Germany,   Japan,   Switzerland
 
NCT01870401
CL0005-01
Yes
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
May 2014

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