Peripheral Artery DiseaseNCT01864278
Lutonix Global SFA Registry
An observational study of Peripheral Artery Disease, run by C. R. Bard at 23 sites in 10 countries.
Trial summary
The registry will enroll patients with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects will be treated with the LUTONIX Drug Coated PTA Dilatation Catheter carrying the CE Mark per current Instructions for Use(IFU) and followed… 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
- Type of treatment
- Medical device
- How many people
- 691 participants
- Where
- 23 sitesin 10 countries
- Study dates
- Dec 2012to Sep 2016
- How long will I take part?
- 2 Years
- 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: Hospital patients (global registry)
Who may be able to join
- Male or non-pregnant female ≥18 years of age;
- Rutherford Clinical Category ≤ 4;
- Patient is willing to provide 5-year informed consent and comply with the required follow up;
- Stenotic or obstructive vascular lesions of the femoropopliteal artery;
- Lesion(s) can be treated with available LUTONIX Drug Coated PTA Dilatation Catheter device size matrix per current IFU;
- At least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is NOT permitted; treatment of in-flow disease is permitted prior to treatment with the LUTONIX Drug Coated PTA Dilatation Catheter).
Who cannot join
- Patient is currently participating in an investigational drug or device study;
- Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast;
- Pregnant or planning on becoming pregnant or men intending to father a child;
- Rutherford Class > 4
- Known inadequate distal outflow or planned future treatment of vascular disease distal to the target lesion
Trial locations and contacts
23 sites in 10 countries.
23 sites in 10 countries
Germany5 sites
Karolinen Hospital Huesten
Arnsberg, 59759
Diakoniewerk Muenchen
München, 80331
Medinos Kliniken Sonneberg
Sonneberg, 96515
Kreiskrankenhaus Viechtach
Viechtach, 94234
Klinikum Weiden
Weiden, 92637
United Kingdom5 sites
Royal Liverpool
Liverpool, L7 8XP
St Thomas' Hospital
London, SE1 7EH
Manchester Royal Infirmary
Manchester, M13 9WL
Wythenshawe Hospital
Manchester, M23 9LT
Freeman Hospital
Newcastle upon Tyne, WE7 7DN
Italy4 sites
AO Cardinal Massaia
Asti, 14100
IRCCS Policlinico San Donato
San Donato Milanese, 20097
Azienda Ospedaliera della Valtellina e dalla Valchiavenna
Sondalo, 23035
AO Ordine Mauriziano
Torino
Poland3 sites
Szpital Uniwersytecki nr 2 im. Biziel
Bydgoszcz, 85-168
Szpital Kliniczny Przemienienia Panskiego
Poznan, 61-848
Voivodship Specialist Hospital
Torun, 87-100
About this study
Official title: A Prospective, Global Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the LUTONIX Drug Coated PTA Dilatation Catheter
The registry will enroll patients with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects will be treated with the LUTONIX Drug Coated PTA Dilatation Catheter carrying the CE Mark per current Instructions for Use(IFU) and followed clinically for a minimum of 2 years.
- Conditions
- Peripheral Artery Disease
- Being tested
- Lutonix Drug Coated Balloon
- 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 BalloonDevice
Subject will receive treatment with the Lutonix Drug Coated Balloon
| Study group | Role | What they receive |
|---|---|---|
| Lutonix Drug Coated Balloon | Paclitaxel coated ballooncatheter Receives: Device: Lutonix Drug Coated Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Target Lesion Revascularization (TLR)
Efficacy: Freedom from TLR at 12 months.
Measured: 12 months
Freedom from Target Vessel Revascularization(TVR), major index limb amputation, and device- and procedure-related death
Safety: Freedom at 30 days from TVR, major index limb amputation, and device- and procedure-related death
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startDec 2012
- Primary completionJul 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 691 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bard Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864278
- Sponsor's protocol ID
- CL0004-01
- Status last verified
- Nov 2016
- First submitted
- 21 May 2013
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Thieme M, Von Bilderling P, Paetzel C, Karnabatidis D, Perez Delgado J, Lichtenberg M; Lutonix Global SFA Registry Investigators. The 24-Month Results of the Lutonix Global SFA Registry: Worldwide Experience With Lutonix Drug-Coated Balloon. JACC Cardiovasc Interv. 2017 Aug 28;10(16):1682-1690. doi: 10.1016/j.jcin.2017.04.041. Epub 2017 Aug 2.
PubMed 28780030
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Global Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the LUTONIX Drug Coated PTA Dilatation Catheter
- ClinicalTrials.gov ID
- NCT01864278
- Acronym / sponsor ID
- CL0004-01
- Conditions
- Peripheral Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 691 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Collaborators
- Bard Ltd
- Study start
- Dec 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 May 2013 (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 ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects will be treated with the LUTONIX Drug Coated PTA Dilatation Catheter carrying the CE Mark per current Instructions for Use(IFU) and followed clinically for a minimum of 2 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lutonix Drug Coated Balloon | – | Device: Lutonix Drug Coated BalloonPaclitaxel coated ballooncatheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital patients (global registry)
Key inclusion criteria (6 listed)
- Male or non-pregnant female ≥18 years of age;
- Rutherford Clinical Category ≤ 4;
- Patient is willing to provide 5-year informed consent and comply with the required follow up;
- Stenotic or obstructive vascular lesions of the femoropopliteal artery;
- Lesion(s) can be treated with available LUTONIX Drug Coated PTA Dilatation Catheter device size matrix per current IFU;
Key exclusion criteria (5 listed)
- Patient is currently participating in an investigational drug or device study;
- Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast;
- Pregnant or planning on becoming pregnant or men intending to father a child;
- Rutherford Class > 4
- Known inadequate distal outflow or planned future treatment of vascular disease distal to the target lesion
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 BalloonSubject will receive treatment with the Lutonix Drug Coated Balloon | Device | Lutonix Drug Coated Balloon |
Primary outcome
Freedom from Target Lesion Revascularization (TLR)
Time frame: 12 months
Efficacy: Freedom from TLR at 12 months.
Freedom from Target Vessel Revascularization(TVR), major index limb amputation, and device- and procedure-related death
Time frame: 30 days
Safety: Freedom at 30 days from TVR, major index limb amputation, and device- and procedure-related death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Derived from this study: PubMed 28780030Thieme M, Von Bilderling P, Paetzel C, Karnabatidis D, Perez Delgado J, Lichtenberg M; Lutonix Global SFA Registry Investigators. The 24-Month Results of the Lutonix Global SFA Registry: Worldwide Experience With Lutonix Drug-Coated Balloon. JACC Cardiovasc Interv. 2017 Aug 28;10(16):1682-1690. doi: 10.1016/j.jcin.2017.04.041. Epub 2017 Aug 2.
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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.
23 sites in 10 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 23 sites in 10 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Germany, United Kingdom, Italy, Poland, Austria and 5 more countries. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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?
On the ClinicalTrials.gov record for NCT01864278, which also lists 1 linked publication.
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 8 Nov 2016; AzTrials last refreshed its copy on 30 Oct 2026.