- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02043951
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)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5R 1J3
- The Vein Institute of Toronto
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Kuala Lumpur, Malaysia, 50586
- Hospital Kuala Lumpur
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Kuala Lumpur, Malaysia, 56000
- Hospital Universiti Kebangsaan
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Kubang Kerian Kelantan, Malaysia, 16150
- Hospital Universiti Sains Malaysia
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Sarawak, Malaysia, 93586
- Hospital Umum Sarawak
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Christchurch, New Zealand, 8140
- Christchurch Hospital
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Newtown, Wellington, New Zealand, 6021
- Wellington Regional Vascular Centre
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Tauranga, New Zealand, 3110
- Tauranga Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Single Arm: Lutonix Drug Coated Balloon
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy: Freedom from target lesion revascularization (TLR)
Time Frame: 12 months
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12 months
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Safety
Time Frame: 30 Days
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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.
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30 Days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute Device Success
Time Frame: 30 days, 6 and 12 months
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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.
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30 days, 6 and 12 months
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Procedural Success
Time Frame: 30 days, 6 and 12 months
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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.
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30 days, 6 and 12 months
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Freedom separately from each of the following adverse events listed below:
Time Frame: 30 days, 6 and 12 months
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30 days, 6 and 12 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CL0015-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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