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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02043951
Registration number
NCT02043951
Ethics application status
Date submitted
17/01/2014
Date registered
23/01/2014
Date last updated
13/07/2016
Titles & IDs
Public title
Use and Safety of the LUTONIX® Drug Coated Balloon Catheter in Arteries of the Lower Extremity
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Scientific 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)
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Secondary ID [1]
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CL0015-01
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Universal Trial Number (UTN)
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Trial acronym
LEG
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Peripheral Artery Disease
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Single Arm: Lutonix Drug Coated Balloon -
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Efficacy: Freedom from target lesion revascularization (TLR)
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Assessment method [1]
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Timepoint [1]
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12 months
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Primary outcome [2]
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Safety
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Assessment method [2]
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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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Timepoint [2]
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30 Days
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Secondary outcome [1]
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Acute Device Success
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Assessment method [1]
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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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Timepoint [1]
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30 days, 6 and 12 months
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Secondary outcome [2]
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Procedural Success
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Assessment method [2]
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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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Timepoint [2]
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30 days, 6 and 12 months
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Secondary outcome [3]
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Freedom separately from each of the following adverse events listed below:
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Assessment method [3]
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* 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.
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Timepoint [3]
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30 days, 6 and 12 months
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2016
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Sample size
Target
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Accrual to date
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Final
59
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Ontario
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Country [2]
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Malaysia
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State/province [2]
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Kuala Lumpur
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Country [3]
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Malaysia
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State/province [3]
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Kubang Kerian Kelantan
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Country [4]
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Malaysia
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State/province [4]
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Sarawak
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Country [5]
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New Zealand
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State/province [5]
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Christchurch
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Country [6]
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New Zealand
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State/province [6]
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Newtown, Wellington
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Country [7]
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New Zealand
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State/province [7]
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Tauranga
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
C. R. Bard
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02043951
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02043951
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