Peripheral Artery DiseaseLEGNCT02043951
Use and Safety of the LUTONIX® Drug Coated Balloon Catheter in Arteries of the Lower Extremity
An observational study of Peripheral Artery Disease, run by C. R. Bard at 8 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Lutonix Drug Coated Balloon Catheter
- Type of treatment
- Medical device
- How many people
- 59 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Jan 2014to Jan 2016
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Real-world patients requiring drug coated balloon treatment.
Who may be able to join
- ≥ 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Malaysia4 sites
Hospital Kuala Lumpur
Kuala Lumpur, 50586
Hospital Universiti Kebangsaan
Kuala Lumpur, 56000
Hospital Universiti Sains Malaysia
Kubang Kerian Kelantan, 16150
Hospital Umum Sarawak
Sarawak, 93586
New Zealand3 sites
Christchurch Hospital
Christchurch, 8140
Wellington Regional Vascular Centre
Newtown, Wellington, 6021
Tauranga Hospital
Tauranga, 3110
About this study
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)
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.
Read the 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.
- Conditions
- Peripheral Artery Disease
- Being tested
- Lutonix Drug Coated Balloon Catheter
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutonix Drug Coated Balloon CatheterDevice
| Study group | Role | What they receive |
|---|---|---|
| Single Arm: Lutonix Drug Coated Balloon | Not described Receives: Device: Lutonix Drug Coated Balloon Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Freedom from target lesion revascularization (TLR)
Measured: 12 months
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.
Measured: 30 Days
Secondary outcomes (3)
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.
Measured: 30 days, 6 and 12 months
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.
Measured: 30 days, 6 and 12 months
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.
Measured: 30 days, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionJan 2016
Why it stopped: Originally 500 patients were planned but only 59 have been enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043951
- Sponsor's protocol ID
- CL0015-01
- Acronym
- LEG
- Status last verified
- Jul 2016
- First submitted
- 17 Jan 2014
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02043951
- Acronym / sponsor ID
- LEG / CL0015-01
- Conditions
- Peripheral Artery Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Originally 500 patients were planned but only 59 have been enrolled
- Enrolment
- 59 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm: Lutonix Drug Coated Balloon | – | Device: Lutonix Drug Coated Balloon Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Real-world patients requiring drug coated balloon treatment.
Key inclusion criteria (5 listed)
- ≥ 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lutonix Drug Coated Balloon Catheter | Device | Single Arm: Lutonix Drug Coated Balloon |
Primary outcome
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.
3 secondary outcomes
Acute Device Success
Time frame: 30 days, 6 and 12 months
Procedural Success
Time frame: 30 days, 6 and 12 months
Freedom separately from each of the following adverse events listed below:
Time frame: 30 days, 6 and 12 months
Results and safety
The study was stopped early (reason given: Originally 500 patients were planned but only 59 have been enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease, run by C. R. Bard at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Malaysia, New Zealand, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Originally 500 patients were planned but only 59 have been enrolled). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: Freedom from target lesion revascularization (TLR) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2016.