Use and Safety of the LUTONIX® Drug Coated Balloon Catheter in Arteries of the Lower Extremity (LEG)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02043951|
Recruitment Status : Terminated (Originally 500 patients were planned but only 59 have been enrolled)
First Posted : January 23, 2014
Last Update Posted : July 13, 2016
|Condition or disease||Intervention/treatment|
|Peripheral Artery Disease||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 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 [Patient Registry]|
|Actual Enrollment :||59 participants|
|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)|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||January 2016|
|Single Arm: Lutonix Drug Coated Balloon||Device: Lutonix Drug Coated Balloon Catheter|
- 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.
- 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)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043951
|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|
|Christchurch, New Zealand, 8140|
|Wellington Regional Vascular Centre|
|Newtown, Wellington, New Zealand, 6021|
|Tauranga, New Zealand, 3110|