Peripheral Artery DiseaseNCT01790243
LEVANT 2 Safety Registry
A study testing Lutonix Drug Coated Balloon and Standard PTA Balloon in people with Peripheral Artery Disease and Femoropopliteal Artery Occlusion, run by C. R. Bard at 8 sites in United States.
Trial summary
The primary objective of the LEVANT 2 Extended Follow-up Post-Approval Study (PAS 1) is to evaluate the long-term performance of the Lutonix Drug Coated Balloon (DCB) versus Percutaneous Transluminal Balloon Angioplasty (PTA) in the treatment of stenosis or occlusion of the femoropopliteal arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis
- What is being tested?
- Lutonix Drug Coated Balloon and Standard PTA Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,189 participants
- Where
- 8 sitesUnited States
- Study dates
- 20 Jul 2011to 1 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
None listed.
Who cannot join
- Patients will be excluded if ANY of the following conditions apply:
- Pregnant or planning on becoming pregnant or men intending to father children;
- Life expectancy of <5 years;
- Patient is currently participating in an investigational drug or other device study or previously enrolled in this study; NOTE: Enrollment in another clinical trial during the follow up period is not allowed.
- History of hemorrhagic stroke within 3 months;
- Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure;
Show all 19Show fewer
- History of MI, thrombolysis or angina within 2 weeks of enrollment;
- Rutherford Class 0, 1, 5 or 6;
- Renal failure or chronic kidney disease with MDRD GFR ≤30 ml/min per 1.73 m2 (or serum creatinine ≥2.5 mg/L within 30 days of index procedure or treated with dialysis);
- Prior vascular surgery of the index limb, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion;
- Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication;
- Anticipated use of IIb/IIIa inhibitor prior to randomization;
- Ipsilateral retrograde access;
- Composite lesion length is >15 cm or there is no normal proximal arterial segment in which duplex flow velocity can be measured;
- Significant inflow disease. Successful treatment of inflow disease allowed prior to target lesion treatment;
- Known inadequate distal outflow (>50 % stenosis of distal popliteal and/or all three tibial vessels), or planned future treatment of vascular disease distal to the target lesion;
- Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel;
- Severe calcification that renders the lesion un-dilatable;
- Use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
TriHealth Heart Institute
Cincinnati, Ohio, 45220
Mission Cardiovascular Research Institute
Fremont, California, 94538
Jackson Heart Clinic/St. Dominic's Hospital
Jackson, Mississippi, 39216
Mission Research Institute
New Braunfels, Texas, 78130
New York Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, 10021
Mercy Hospital
Springfield, Missouri, 65804
Holy Name Medical Center
Teaneck, New Jersey, 07666
Metro Health Hospital
Wyoming, Michigan, 49519
About this study
Official title: A Prospective, Multicenter, Registry of the Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries (LEVANT 2 Safety Registry)
The primary objective of the LEVANT 2 Extended Follow-up Post-Approval Study (PAS 1) is to evaluate the long-term performance of the Lutonix Drug Coated Balloon (DCB) versus Percutaneous Transluminal Balloon Angioplasty (PTA) in the treatment of stenosis or occlusion of the femoropopliteal arteries.
- Being tested
- Lutonix Drug Coated Balloon, Standard PTA 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
Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries.
Standard PTA BalloonDevice
Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries.
| Study group | Role | What they receive |
|---|---|---|
| Lutonix Drug Coated Balloon | Experimental | Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter Receives: Device: Lutonix Drug Coated Balloon |
| Standard Uncoated Angioplasty Balloon | Active comparator | PTA Catheter Receives: Device: Standard PTA Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Unanticipated Device- or Drug-Related Serious Adverse Events at 60 Months Post Index Procedure.
Measured: From index procedure to 60 months Post Index Procedure
Secondary outcomes (9)
Number of Subjects With Freedom From Death, Index-Limb Amputation, and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure
Number of subjects with Freedom from all-cause death, index limb amputation above the ankle and Target Vessel Revascularization (TVR) (VIVA Safety Endpoint)
Measured: 30 days post index procedure
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure
Measured: 1, 6, 12, 24, 36, 48, and 60 months post index procedure (PPI)
Percentage of Participants With Primary Patency of the Target Lesion at 6, 12, and 24 Months Post Index Procedure
Primary Patency is defined as the absence of target lesion restenosis (defined by DUS peak systolic velocity ratio (PSVR) ≥2.5) and freedom from target lesion revascularization (TLR).
Measured: 6, 12, and 24 months post index procedure
Number of Acute Device Success at Time of Index Procedure
Device Success was defined as the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion, without balloon rupture or inflation/deflation abnormalities and a successful withdrawal of the study system.
Measured: At time of index procedure
Number of Participants With Technical and Procedural Success
Technical Success is defined as successful access and deployment of the device and visual estimate of ≤30% diameter residual stenosis during the index procedure without deployment of a bailout stent.
Procedural Success is defined as attainment of ≤30% residual stenosis in the treatment area by independent core lab analysis without serious adverse events during the index procedure.
Measured: At time of index procedure
Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 12, and 24 Months Post Index Procedure
Measured: 6, 12, and 24 months post index procedure
Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure
Percentage of subjects with Alternative Primary Patency based on alternative definitions of duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) <2.0 and <3.0 at 6, 12, and 24 months post index procedure. DUS PSVR was calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.
Measured: 6, 12, and 24 months post index procedure
Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline
The endpoint summarizes the change in index-limb Rutherford Classification of participants from baseline through 24 months. Data is presented as shift from baseline Rutherford Classification data using the following categories: 1) Improvement, 2) Same, and 3) Worsened.
Measured: 6, 12, and 24 months post index procedure
Change in Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Compared to Baseline
Mean change from baseline values. The Ankle Brachial Index (ABI) is defined as a ratio of ankle to brachial (upper arm) artery systolic blood pressure and aims at determining how well the blood is flowing in the legs.
Measured: 6, 12, and 24 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study start20 Jul 2011
- Primary completion27 Nov 2015
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,189 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth Rosenfield, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790243
- Sponsor's protocol ID
- CL0006-01
- Status last verified
- May 2020
- First submitted
- 8 Feb 2013
- Last updated
- 5 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Registry of the Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries (LEVANT 2 Safety Registry)
- ClinicalTrials.gov ID
- NCT01790243
- Acronym / sponsor ID
- CL0006-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,189 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2011 (actual)
- Primary completion
- 27 Nov 2015 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 13 Feb 2013 (estimated)
- Results
- Posted 5 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the LEVANT 2 Extended Follow-up Post-Approval Study (PAS 1) is to evaluate the long-term performance of the Lutonix Drug Coated Balloon (DCB) versus Percutaneous Transluminal Balloon Angioplasty (PTA) in the treatment of stenosis or occlusion of the femoropopliteal arteries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lutonix Drug Coated Balloon | Experimental | Device: Lutonix Drug Coated BalloonFormerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter |
| Standard Uncoated Angioplasty Balloon | Active comparator | Device: Standard PTA BalloonPTA Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (19 listed)
- Pregnant or planning on becoming pregnant or men intending to father children;
- Life expectancy of <5 years;
- Patient is currently participating in an investigational drug or other device study or previously enrolled in this study; NOTE: Enrollment in another clinical trial during the follow up period is not allowed.
- History of hemorrhagic stroke within 3 months;
- Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after 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 BalloonUse of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries. | Device | Lutonix Drug Coated Balloon |
| Standard PTA BalloonUse of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries. | Device | Standard Uncoated Angioplasty Balloon |
Primary outcome
Number of Participants With Unanticipated Device- or Drug-Related Serious Adverse Events at 60 Months Post Index Procedure.
Time frame: From index procedure to 60 months Post Index Procedure
9 secondary outcomes
Number of Subjects With Freedom From Death, Index-Limb Amputation, and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure
Time frame: 30 days post index procedure
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure
Time frame: 1, 6, 12, 24, 36, 48, and 60 months post index procedure (PPI)
Percentage of Participants With Primary Patency of the Target Lesion at 6, 12, and 24 Months Post Index Procedure
Time frame: 6, 12, and 24 months post index procedure
Number of Acute Device Success at Time of Index Procedure
Time frame: At time of index procedure
Number of Participants With Technical and Procedural Success
Time frame: At time of index procedure
Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 12, and 24 Months Post Index Procedure
Time frame: 6, 12, and 24 months post index procedure
Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure
Time frame: 6, 12, and 24 months post index procedure
Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline
Time frame: 6, 12, and 24 months post index procedure
Change in Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Compared to Baseline
Time frame: 6, 12, and 24 months from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kenneth Rosenfield, MD principal investigator
Massachusetts General Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lutonix Drug Coated Balloon and Standard PTA Balloon in people with Peripheral Artery Disease and Femoropopliteal Artery Occlusion, run by C. R. Bard at 8 sites in United States.
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 19 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 5 Jun 2020. 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 United States. 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?
Yes. Results are posted in the registry (first posted 5 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Unanticipated Device- or Drug-Related Serious Adverse Events at 60 Months Post Index Procedure. (time frame: From index procedure to 60 months Post Index Procedure). 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 5 Jun 2020.