Use and Safety of the LUTONIX® Drug Coated Balloon Catheter in Arteries of the Lower Extremity (LEG)
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.
Peripheral Artery Disease
Device: Lutonix Drug Coated Balloon Catheter
|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)|
- 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.
- 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)
- 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.
|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)|
|Single Arm: Lutonix Drug Coated Balloon||Device: Lutonix Drug Coated Balloon Catheter|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02043951
|Contact: Rudy Padua||Rudy.Padua@crbard.com|
|Bay Radiology Ltd Tauranga||Recruiting|
|Tauranga, New Zealand|
|Principal Investigator: Gerard Eagar, MD|