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
  Purpose

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 Intervention Phase
Critical Limb Ischemia
Device: Lutonix DCB
Device: Uncoated PTA Catheter
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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)

Resource links provided by NLM:


Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 480
Study Start Date: May 2013
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lutonix DCB
Lutonix Paclitaxel Drug Coated Balloon
Device: Lutonix DCB
Other Name: LTX DCB
Active Comparator: PTA Catheter
Standard Uncoated Balloon Angioplasty Catheter
Device: Uncoated PTA Catheter
Other Name: PTA

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01870401

Contacts
Contact: Robert M Jardin LutonixResearch@crbard.com

  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

No publications provided

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01870401     History of Changes
Other Study ID Numbers: CL0005-01
Study First Received: May 7, 2013
Last Updated: May 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014