Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by C. R. Bard
Information provided by (Responsible Party):
C. R. Bard Identifier:
First received: January 17, 2014
Last updated: February 2, 2015
Last verified: February 2015

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 2 years.

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: 2 Years
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 ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    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, 12, and 24 months ] [ Designated as safety issue: No ]
    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, 12, and 24 months ] [ Designated as safety issue: No ]
    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, 12, and 24 months ] [ Designated as safety issue: No ]
    • All-cause death
    • Device- and procedure-related mortality
    • Unexpected device or drug-related AEs
    • Unplanned 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 and 24 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.

Estimated Enrollment: 500
Study Start Date: January 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (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 2 years.

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
Genders Eligible for Study:   Both
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
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 identifier: NCT02043951

Contact: Rudy Padua

Scarborough Hospital Recruiting
Ontario, Canada, M1P 2V5
Principal Investigator: Sanjoy Kundu, MD         
Hospital Universiti Sains Malaysia Recruiting
Kelantan, Malaysia, 16150
Principal Investigator: Shafie Abdullah, MD         
Hospital Kuala Lumpur Recruiting
Kuala Lumpur, Malaysia, 50586
Principal Investigator: Zainal Ariffin Azizi, MD         
Hospital Universiti Kebangsaan Recruiting
Kuala Lumpur, Malaysia, 56000
Principal Investigator: Rozman Zakaria, MD         
Hospital Umum Sarawak Recruiting
Sarawak, Malaysia, 93586
Principal Investigator: Luk Thieng Loong, MD         
New Zealand
Christchurch Hospital Recruiting
Addington, New Zealand, 8011
Principal Investigator: Martin Krauss, MD         
Wellington Regional Vascular Centre Recruiting
Newtown, Wellington, New Zealand, 6021
Principal Investigator: Kes Wicks, MD         
Bay Radiology Ltd Tauranga Recruiting
Tauranga, New Zealand
Principal Investigator: Gerard Eagar, MD         
Sponsors and Collaborators
C. R. Bard
  More Information

No publications provided

Responsible Party: C. R. Bard Identifier: NCT02043951     History of Changes
Other Study ID Numbers: CL0015-01
Study First Received: January 17, 2014
Last Updated: February 2, 2015
Health Authority: Malaysia: Ministry of Health

Additional relevant MeSH terms:
Peripheral Arterial Disease
Arterial Occlusive Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Vascular Diseases processed this record on March 03, 2015