Peripheral Artery DiseaseNCT02278991
Bard LifeStent and Lutonix DCB for Treatment of Long Lesions in Femoropopliteal Arteries
An observational study of Peripheral Artery Disease, run by C. R. Bard at 12 sites in 3 countries.
Trial summary
Objective of this study is to evaluate the safety and efficacy of Lutonix 035 Drug Coated Dilatation PTA Catheter with Bard LifeStent Vascular Stent (hereinafter referred to as LifeStent) for treatment of long (10-24 cm) lesions in the SFA and/or proximal popliteal artery. 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
- 149 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Oct 2014to 2 Oct 2018
- 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
Who may be able to join
None listed.
Who cannot join
- Pregnant, lactating, or planning on becoming pregnant or men intending to father children;
- Contraindication to Lutonix DCB or LifeStent® per current IFU;
- Life expectancy of <1 year;
- Inability to take required antiplatelet/anticoagulant medications per the LifeStent® and Lutonix DCB IFU, or known contraindication (including allergic reaction) or sensitivity to contrast media, nickel, titanium or tantalum that cannot be adequately managed with pre- and post-procedure medication;
- Intended treatment of outflow disease during the index procedure;
- Intended use of laser, atherectomy or cryoplasty during index procedure;
Show all 12Show fewer
- Sudden symptom onset, acute vessel occlusion, or acute or subacute thrombus in target vessel;
- History of stroke within 3 months;
- History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment;
- Participation in an investigational drug or another investigational device study until this study's (Lutonix LifeStent® Study) primary endpoint is reached or previous enrollment in this study;
- Another medical condition, which, in the opinion of the Investigator, may cause the patient to be noncompliant with the CIP or confound data interpretation;
- Target vessel and/or lesion involves a previously placed stent.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Germany10 sites
Klinikum Arnsberg
Arnsberg, 59755
Herz- und Gefäßzentrum Bad Bevensen
Bad Bevensen, 29549
Universitäts-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, 79189
Angiologikum Hamburg
Hamburg, 22527
Klinik Immenstadt
Immenstadt im Allgäu, 87509
Klinikum Kassel
Kassel, 34125
UKSH - Campus Lübeck
Lübeck, 23538
RoMed Klinikum Rosenheim
Rosenheim, 83022
Gefäßzentrum Sonneberg
Sonneberg, 96515
Klinikum Weiden
Weiden, 92637
About this study
Official title: A Prospective, Multicenter, Single-Arm, Post-Market Study Using the Lutonix Drug Coated Balloon for Post-Dilatation of the Bard LifeStent Vascular Stent for Treatment of Long Lesions in Femoropopliteal Arteries
Objective of this study is to evaluate the safety and efficacy of Lutonix 035 Drug Coated Dilatation PTA Catheter with Bard LifeStent Vascular Stent (hereinafter referred to as LifeStent) for treatment of long (10-24 cm) lesions in the SFA and/or proximal popliteal artery.
Read the detailed description
The study will observe subjects presenting with claudication or ischemic rest pain (Rutherford category 2-4) and long (10-24 cm in length) native lesions in the infra-inguinal segment (superficial femoral artery [SFA] and/or proximal popliteal artery) who are candidates for stenting and pre-/post-dilatation with Drug Coated Balloon (DCB).
- 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 balloon catheter Receives: Device: Lutonix Drug Coated Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency at 12 months.
Primary patency is defined as the absence of target lesion restenosis and freedom from target lesion revascularization.
Measured: 12 months
Freedom from the composite endpoint of death, index limb amputation, and target vessel revascularization at 30 days.
Freedom from the composite endpoint of death, index limb amputation, and target vessel revascularization at 30 days.
Measured: 30 days
Secondary outcomes (10)
Procedural success
Defined as attainment of ≤30% residual stenosis by quantitative angiography immediately after intervention in the absence of peri-procedural complications.
Measured: Immediately after Intervention
Technical success
Defined as attainment of ≤30% residual stenosis by quantitative angiography.
Measured: Immediately after intervention
Device success
Defined as successful delivery of the DCB to the target lesion and performance when used according to the clinical investigational plan.
Measured: Immediately after intervention
Freedom from Target Lesion Revascularization after 30 days, and 6, 12 and 24 months post-index procedure.
Absence of Target Lesion Revascularization.
Measured: 30 days, 6, 12 and 24 months
Freedom from TVR after 30 days, and 6, 12 and 24 months post-index procedure.
Absence of Target Vessel Revascularization.
Measured: 30 days, 6, 12 and 24 months
Change in resting ankle brachial index (ABI) from baseline to 30 days, and 6, 12 and 24 months post-index procedure
The ABI values will be recorded and compared to the baseline values. The ABI is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. A ratio of 0.9-1.3 is in the normal range. Lower ratios indicate bad blood perfusion of the leg.
Measured: 30 days, 6, 12 and 24 months
Change in Rutherford Classification from baseline to 30 days, and 6, 12 and 24 months post-index procedure
Patients are enrolled with a Rutherford grade of 2-4 for their target leg. The Rutherford scale is an indicator for the severity of Peripheral Vascular Disease: 0 = no symptoms, 6 = functional foot is no longer salvageable (leading to foot amputation).
Measured: 30 days, 6, 12 and 24 months
All-cause death
Death by any cause will be counted.
Measured: 30 days, 6, 12 and 24 months
Amputation (above the ankle)-free survival
Amputations above the ankle of the target leg will be counted.
Measured: 30 days, 6, 12 and 24 months
Target limb reintervention for treatment of thrombosis of target vessel or embolization to its distal vasculature
Thrombosis in the target vessel and embolizations below the target lesion will be analazed separately from other stenoses.
Measured: 30 days, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2017
- Study completion2 Oct 2018
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
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Zeller, Prof., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278991
- Sponsor's protocol ID
- CL0022-01
- Status last verified
- Oct 2019
- First submitted
- 28 Oct 2014
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-Arm, Post-Market Study Using the Lutonix Drug Coated Balloon for Post-Dilatation of the Bard LifeStent Vascular Stent for Treatment of Long Lesions in Femoropopliteal Arteries
- ClinicalTrials.gov ID
- NCT02278991
- Acronym / sponsor ID
- CL0022-01
- Conditions
- Peripheral Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Oct 2014 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- 2 Oct 2018 (actual)
- First posted
- 30 Oct 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.
Objective of this study is to evaluate the safety and efficacy of Lutonix 035 Drug Coated Dilatation PTA Catheter with Bard LifeStent Vascular Stent (hereinafter referred to as LifeStent) for treatment of long (10-24 cm) lesions in the SFA and/or proximal popliteal artery.
Detailed description
The study will observe subjects presenting with claudication or ischemic rest pain (Rutherford category 2-4) and long (10-24 cm in length) native lesions in the infra-inguinal segment (superficial femoral artery [SFA] and/or proximal popliteal artery) who are candidates for stenting and pre-/post-dilatation with Drug Coated Balloon (DCB).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lutonix Drug Coated Balloon | – | Device: Lutonix Drug Coated BalloonPaclitaxel coated balloon catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital Patients
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- Pregnant, lactating, or planning on becoming pregnant or men intending to father children;
- Contraindication to Lutonix DCB or LifeStent® per current IFU;
- Life expectancy of <1 year;
- Inability to take required antiplatelet/anticoagulant medications per the LifeStent® and Lutonix DCB IFU, or known contraindication (including allergic reaction) or sensitivity to contrast media, nickel, titanium or tantalum that cannot be adequately managed with pre- and post-procedure medication;
- Intended treatment of outflow disease during the index procedure;
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
Primary patency at 12 months.
Time frame: 12 months
Primary patency is defined as the absence of target lesion restenosis and freedom from target lesion revascularization.
Freedom from the composite endpoint of death, index limb amputation, and target vessel revascularization at 30 days.
Time frame: 30 days
Freedom from the composite endpoint of death, index limb amputation, and target vessel revascularization at 30 days.
10 secondary outcomes
Procedural success
Time frame: Immediately after Intervention
Technical success
Time frame: Immediately after intervention
Device success
Time frame: Immediately after intervention
Freedom from Target Lesion Revascularization after 30 days, and 6, 12 and 24 months post-index procedure.
Time frame: 30 days, 6, 12 and 24 months
Freedom from TVR after 30 days, and 6, 12 and 24 months post-index procedure.
Time frame: 30 days, 6, 12 and 24 months
Change in resting ankle brachial index (ABI) from baseline to 30 days, and 6, 12 and 24 months post-index procedure
Time frame: 30 days, 6, 12 and 24 months
Change in Rutherford Classification from baseline to 30 days, and 6, 12 and 24 months post-index procedure
Time frame: 30 days, 6, 12 and 24 months
All-cause death
Time frame: 30 days, 6, 12 and 24 months
Amputation (above the ankle)-free survival
Time frame: 30 days, 6, 12 and 24 months
Target limb reintervention for treatment of thrombosis of target vessel or embolization to its distal vasculature
Time frame: 30 days, 6, 12 and 24 months
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 9 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Thomas Zeller, Prof. principal investigator
12 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 12 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 0 inclusion and 12 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 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Greece, Poland. 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?
Primary patency at 12 months. (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 9 Oct 2019.