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)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Peripheral Artery Disease
- Sponsor
- C. R. Bard
- Enrollment
- 59
- Locations
- 8
- Primary Endpoint
- Efficacy: Freedom from target lesion revascularization (TLR)
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •≥ 18 years of age;
- •Rutherford Clinical Category ≤ 5;
- •Patient or Legally Authorized Representative is willing to provide informed consent and comply with the required follow up;
- •Stenotic or obstructive vascular lesions in artery(s) of the lower extremity;
- •Lesion(s) can be treated with available LUTONIX Drug Coated Balloon Catheter device size matrix per current country-specific IFU.
Exclusion Criteria
- •Patient is currently participating in an active phase of another investigational drug or device study;
- •Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast.
Outcomes
Primary Outcomes
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 Outcomes
- Procedural Success(30 days, 6 and 12 months)
- Freedom separately from each of the following adverse events listed below:(30 days, 6 and 12 months)
- Acute Device Success(30 days, 6 and 12 months)