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Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries

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ClinicalTrials.gov Identifier: NCT01870401
Recruitment Status : Active, not recruiting
First Posted : June 6, 2013
Last Update Posted : February 1, 2018
Sponsor:
Collaborator:
Bard Ltd
Information provided by (Responsible Party):
C. R. Bard

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Device: Lutonix DCB Device: Uncoated PTA Catheter Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 442 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : June 3, 2013
Estimated Primary Completion Date : July 12, 2018
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lutonix DCB
Lutonix Paclitaxel Drug Coated Balloon
 Device: Lutonix DCB
Other Name: LTX DCB
Active Comparator: PTA Catheter
Standard Uncoated PTA Catheter
 Device: Uncoated PTA Catheter
Other Name: PTA


Outcome Measures
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Primary Outcome Measures :
  1. Freedom from BTK MALE+POD [ Time Frame: 30 days ]
    Composite of all-cause death, above-ankle amputation or major reintervention

  2. Limb Salvage [ Time Frame: 6 months ]
    Freedom from the composite of above ankle amputation

  3. Primary Patency [ Time Frame: 6 months ]
    Freedom from target vessel occlusion and clinically driven target lesion reintervention


Secondary Outcome Measures :
  1. Wound healing [ Time Frame: 30 days; 6 months, 12 months, 24 months, and 36 months ]
    Healed or not, if not, improving, stagnant, worsening

  2. 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)

  3. Hemodynamic outcome [ Time Frame: 30 days and at 6 months, 12 months, 24 months, and 36 months ]
    change in toe & ankle pressures

  4. 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%.

  5. Limb salvage in surviving subjects [ Time Frame: 30 days and at 6, 12, 24, and 36 months ]
    No Amputation of target limb


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT01870401


  Show 53 Study Locations
Sponsors and Collaborators
C. R. Bard
Bard Ltd
Investigators
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
More Information
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Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01870401     History of Changes
Other Study ID Numbers: CL0005-01
First Posted: June 6, 2013    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Ischemia
Pathologic Processes