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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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)
Secondary ID [1] 0 0
CL0015-01
Universal Trial Number (UTN)
Trial acronym
LEG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Lutonix Drug Coated Balloon Catheter

Single Arm: Lutonix Drug Coated Balloon -


Treatment: Devices: Lutonix Drug Coated Balloon Catheter


Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy: Freedom from target lesion revascularization (TLR)
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Safety - 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.
Timepoint [2] 0 0
30 Days
Secondary outcome [1] 0 0
Acute Device Success - 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.
Timepoint [1] 0 0
30 days, 6 and 12 months
Secondary outcome [2] 0 0
Procedural Success - 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.
Timepoint [2] 0 0
30 days, 6 and 12 months
Secondary outcome [3] 0 0
Freedom separately from each of the following adverse events listed below: - 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.
Timepoint [3] 0 0
30 days, 6 and 12 months

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Malaysia
State/province [2] 0 0
Kuala Lumpur
Country [3] 0 0
Malaysia
State/province [3] 0 0
Kubang Kerian Kelantan
Country [4] 0 0
Malaysia
State/province [4] 0 0
Sarawak
Country [5] 0 0
New Zealand
State/province [5] 0 0
Christchurch
Country [6] 0 0
New Zealand
State/province [6] 0 0
Newtown, Wellington
Country [7] 0 0
New Zealand
State/province [7] 0 0
Tauranga

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
C. R. Bard
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02043951
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02043951