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

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)

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.

Study Overview

• Status: Terminated
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5R 1J3
      • The Vein Institute of Toronto
• Malaysia
  • Kuala Lumpur, Malaysia, 50586
    • Hospital Kuala Lumpur
  • Kuala Lumpur, Malaysia, 56000
    • Hospital Universiti Kebangsaan
  • Kubang Kerian Kelantan, Malaysia, 16150
    • Hospital Universiti Sains Malaysia
  • Sarawak, Malaysia, 93586
    • Hospital Umum Sarawak
• New Zealand
  • Christchurch, New Zealand, 8140
    • ChristChurch Hospital
  • Newtown, Wellington, New Zealand, 6021
    • Wellington Regional Vascular Centre
  • Tauranga, New Zealand, 3110
    • Tauranga Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Real-world patients requiring drug coated balloon treatment.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single Arm: Lutonix Drug Coated Balloon	Device: Lutonix Drug Coated Balloon Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy: Freedom from target lesion revascularization (TLR)		12 months
Safety	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.	30 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Device Success	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.	30 days, 6 and 12 months
Procedural Success	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.	30 days, 6 and 12 months
Freedom separately from each of the following adverse events listed below:	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.	30 days, 6 and 12 months

Collaborators and Investigators

• Sponsor: C. R. Bard

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: January 17, 2014
• First Submitted That Met QC Criteria: January 21, 2014
• First Posted (Estimate): January 23, 2014

Study Record Updates

• Last Update Posted (Estimate): July 13, 2016
• Last Update Submitted That Met QC Criteria: July 12, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: CL0015-01