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Use and Safety of the LUTONIX® Drug Coated Balloon Catheter in Arteries of the Lower Extremity (LEG)

This study has been terminated.
(Originally 500 patients were planned but only 59 have been enrolled)
Information provided by (Responsible Party):
C. R. Bard Identifier:
First received: January 17, 2014
Last updated: July 12, 2016
Last verified: July 2016
The registry will enroll patients with claudication or critical limb ischemia and angiographically significant lesion(s) in arteries of the lower extremity. Subjects will be treated with the Lutonix® Drug Coated Balloon Catheter for approved indications according to the current country-specific Instructions for Use (IFU) and followed clinically for 1 year.

Condition Intervention Phase
Peripheral Artery Disease
Device: Lutonix Drug Coated Balloon Catheter
Phase 3

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: A Prospective, Multicenter, Single Arm, Post-Market, Real-World Global Registry Assessing the Clinical Use and Safety of the LUTONIX Drug Coated Balloon Catheter in Arteries of the Lower Extremity (LUTONIX® Lower Extremity Global (LEG) Registry)

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

Primary Outcome Measures:
  • Efficacy: Freedom from target lesion revascularization (TLR) [ Time Frame: 12 months ]
  • Safety [ Time Frame: 30 Days ]
    Freedom from the composite endpoint of target vessel revascularization (TVR), major amputation and major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of index limb and device- and procedure-related death.

Secondary Outcome Measures:
  • Acute Device Success [ Time Frame: 30 days, 6 and 12 months ]
    Device success is defined as, a per device basis, the achievement of successful delivery and deployment of the registry device(s) as intended at the intended target lesion, without balloon rupture or inflation/deflation abnormalities and a successful withdrawal of the registry system. If a device is inserted into the subject but not used due to user error (e.g. inappropriate balloon length or transit time too long) this device will not be included in the device success assessment.

  • Procedural Success [ Time Frame: 30 days, 6 and 12 months ]
    Attainment of ≤30% residual stenosis by visual estimate in the treatment area above the knee and attainment of ≤50% residual stenosis by visual estimate in the treatment area below the knee without major adverse events during the index procedure.

  • Freedom separately from each of the following adverse events listed below: [ Time Frame: 30 days, 6 and 12 months ]
    • All-cause death
    • Device- and procedure-related mortality
    • Unexpected device or drug-related AEs
    • Index limb amputation (major and minor reported separately)
    • Reintervention for treatment of thrombosis of the target vessel
    • Reintervention for embolization to its distal vasculature
    • TLR (at 6 months)
    • TVR
    • Composite of all-cause perioperative (≤30 day) death and from the following: index limb amputation, index limb reintervention, and index-limb-related death
    • Major amputation and major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of index limb.

Enrollment: 59
Study Start Date: January 2014
Study Completion Date: January 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Single Arm: Lutonix Drug Coated Balloon Device: Lutonix Drug Coated Balloon Catheter

Detailed Description:

This post-market registry is intended to assess the clinical use and safety of the Lutonix® Drug Coated Balloon Catheter in a heterogeneous patient population in real world clinical practice. Up to 500 patients will be enrolled in order to allow identification and assessment of rare adverse events (AEs) as well as outcomes in subpopulations defined by subject and lesion characteristics. All subjects will be followed for 1 year.

This registry is performed with marketed devices within the indications for use. There are no additional treatments or exams that will take place within this registry.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Real-world patients requiring drug coated balloon treatment.

Inclusion Criteria:

  1. ≥ 18 years of age;
  2. Rutherford Clinical Category ≤ 5;
  3. Patient or Legally Authorized Representative is willing to provide informed consent and comply with the required follow up;
  4. Stenotic or obstructive vascular lesions in artery(s) of the lower extremity;
  5. Lesion(s) can be treated with available LUTONIX Drug Coated Balloon Catheter device size matrix per current country-specific IFU.

Exclusion Criteria:

  1. Patient is currently participating in an active phase of another investigational drug or device study;
  2. Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast.
  Contacts and Locations
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Please refer to this study by its identifier: NCT02043951

Canada, Ontario
The Vein Institute of Toronto
Toronto, Ontario, Canada, M5R 1J3
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia, 50586
Hospital Universiti Kebangsaan
Kuala Lumpur, Malaysia, 56000
Hospital Universiti Sains Malaysia
Kubang Kerian Kelantan, Malaysia, 16150
Hospital Umum Sarawak
Sarawak, Malaysia, 93586
New Zealand
Christchurch Hospital
Christchurch, New Zealand, 8140
Wellington Regional Vascular Centre
Newtown, Wellington, New Zealand, 6021
Tauranga Hospital
Tauranga, New Zealand, 3110
Sponsors and Collaborators
C. R. Bard
  More Information

Responsible Party: C. R. Bard Identifier: NCT02043951     History of Changes
Other Study ID Numbers: CL0015-01
Study First Received: January 17, 2014
Last Updated: July 12, 2016

Additional relevant MeSH terms:
Peripheral Arterial Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases processed this record on April 28, 2017