AzTrials
AzTrials

AtherosclerosisPhase 1/2LEVANT INCT00930813

LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis

A Phase 1/2 study testing Lutonix Catheter and Standard uncoated Balloon Angioplasty Catheter in people with Atherosclerosis and Vascular Disease, run by C. R. Bard at 10 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the study is to assess the safety and efficacy of the Lutonix Catheter for treatment of stenosis of the femoropopliteal arteries by direct comparison to standard balloon angioplasty. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lutonix Catheter and Standard uncoated Balloon Angioplasty Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
10 sitesin 2 countries
Study dates
Jun 2009to Dec 2011
Phase
Phase 1/2
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

  • Clinical Criteria
  • Male or non-pregnant female ≥18 years of age.
  • Rutherford Clinical Category 2-5
  • Patient is willing to provide informed consent and comply with the required follow up visits, testing schedule, and medication regimen Angiographic Criteria
  • A single de novo or restenotic atherosclerotic lesion >70% in the SFA or popliteal artery that is ≥4 cm and ≤15 cm in total length.
  • Reference vessel diameter ≥4 mm and ≤ 6mm
  • Successful wire crossing of lesion
  • A patent inflow artery free from significant lesion (>50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of inflow artery lesions)

Who cannot join

  • Pregnant or planning on becoming pregnant in < 2yrs
  • Live expectancy of <2 years
  • Patient actively participating in another investigational device or drug study
  • History of hemorrhagic stroke within 3 months
  • Previous or planned surgical or interventional procedure within 30 days of index procedure
  • Chronic renal insufficiency with creatinine >2.5 mg/L
Show all 17Show fewer
  • Prior surgery of the target lesion
  • Inability to take required study medications
  • Anticipated use of IIb/IIIa inhibitor prior to randomization
  • Lesion length is <4 cm or >15 cm or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured
  • Known inadequate distal outflow
  • Significant inflow disease
  • Acute or sub-acute thrombus in target vessel
  • Severe lesion calcification
  • Acute vessel occlusion or sudden symptom onset
  • Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.)
  • Prior participation in the current study

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

Germany9 sites

  • Herz Zentrum

    Bad Krozingen

  • Jewish Hospital

    Berlin

  • St Katharenen Cardiovascular Center

    Frankfurt

  • Hamburg Unversity Cardiovascular Center

    Hamburg

  • Park Krankenhaus - University of Leipzig

    Leipzig

  • Universitätsklinikum

    Magdeburg

  • St. Franziskus

    Münster

  • Klinikum Rosenheim

    Rosenheim

  • Katharinenhospital

    Stuttgart

Other trials in Germany

Belgium1 site

  • Sint Blasius

    Dendermonde

Other trials in Belgium

About this study

Official title: A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Lutonix Catheter vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries With and Without Stenting.

The purpose of the study is to assess the safety and efficacy of the Lutonix Catheter for treatment of stenosis of the femoropopliteal arteries by direct comparison to standard balloon angioplasty.

Read the detailed description

The LEVANT I trial will enroll patients presenting with clinical evidence of claudication or critical limb ischemia and an angiographically significant lesion in the femoropopliteal arteries. Patients will be randomized to treatment with either the Lutonix Catheter or standard balloon angioplasty after predilation.

Being tested
Lutonix Catheter, Standard uncoated Balloon Angioplasty Catheter
Keywords
Drug coated balloon, SFA disease, Femoropopliteal disease, Angioplasty, PAD, Paclitaxel, Tubulin modulators, Antineoplastic Agents, Mitosis Modulators, Balloon angioplasty, Local drug delivery, Restenosis, Drug-coated balloon
Medical subject headings
Atherosclerosis, Vascular Diseases, Arteriosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lutonix CatheterDevice

    Also called DCB, Drug coated balloon

    Paclitaxel Coated Balloon Catheter

  • Standard uncoated Balloon Angioplasty CatheterDevice

    plain, uncoated angioplasty balloon catheter

Study groups in NCT00930813
Study groupRoleWhat they receive
Lutonix CatheterExperimentalPaclitaxel coated Balloon Catheter
Receives: Device: Lutonix Catheter
Standard uncoated Balloon Angioplasty CatheterActive comparatoruncoated angioplasty balloon
Receives: Device: Standard uncoated Balloon Angioplasty Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Angiographic Late Lumen Loss

    Loss in analysis segment (the treated segment including 10mm distal and proximal) minimal lumen diameter from post-procedure through follow-up angiography at 6 months.

    Measured: 6 months

Secondary outcomes (10)

  1. Safety - Device Related Adverse Events

    Measured: 30 days

  2. Primary Patency of Treated Segment

    Measured: 6, 12, 24 months

  3. Target Lesion Revascularization

    Measured: 6, 12, 24 months

  4. Target Vessel Revascularization

    Measured: 6, 12, 24 months

  5. Device Success

    Successful delivery and deployment of the first inserted study device (in overlapping setting a successful delivery and deployment of the first and second study device) at the intended target lesion and successful withdrawal of the study device with attainment of final residual stenosis of less than 30% of the target lesion by quantitative vessel angiography (QVA).

    Measured: at procedure

  6. Procedural Success

    Completion of the procedure with less than 30% residual stenosis by QVA of the target lesion (after prolonged dilation and stenting, if necessary)

    Measured: at procedure

  7. Change in Ankle-brachial Index

    Measured: pre-procedure, 6, 12 and 24 months

  8. Change in Walking Impairment Questionnaire (WIQ)

    Measured: pre-procedure, 6, 12 and 24 months

  9. Change in Rutherford Grade

    Measured: pre-procedure,6, 12 and 24 months

  10. Serum Paclitaxel Levels - in Subsets of Patients

    Measured: 0, 1, 3 hours and pre-discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionJun 2010
  4. Study completionDec 2011

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00930813
Sponsor's protocol ID
CL0012-01
Acronym
LEVANT I
Status last verified
Nov 2015
First submitted
30 Jun 2009
Last updated
21 Dec 2015
Data monitoring committee
Yes

Publications

  • Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008 Feb 14;358(7):689-99. doi: 10.1056/NEJMoa0706356.

    PubMed 18272892

  • Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008 Sep 23;118(13):1358-65. doi: 10.1161/CIRCULATIONAHA.107.735985. Epub 2008 Sep 8.

    PubMed 18779447

  • Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.

    PubMed 42573020

  • Ouriel K, Adelman MA, Rosenfield K, Scheinert D, Brodmann M, Pena C, Geraghty P, Lee A, White R, Clair DG. Safety of Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease. JACC Cardiovasc Interv. 2019 Dec 23;12(24):2515-2524. doi: 10.1016/j.jcin.2019.08.025. Epub 2019 Sep 28.

    PubMed 31575518

  • Scheinert D, Duda S, Zeller T, Krankenberg H, Ricke J, Bosiers M, Tepe G, Naisbitt S, Rosenfield K. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv. 2014 Jan;7(1):10-9. doi: 10.1016/j.jcin.2013.05.022.

    PubMed 24456716

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lutonix Catheter and Standard uncoated Balloon Angioplasty Catheter in people with Atherosclerosis and Vascular Disease, run by C. R. Bard at 10 sites in 2 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 8 inclusion and 17 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 21 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany, Belgium. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Dec 2015). 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?

Angiographic Late Lumen Loss (time frame: 6 months). 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 NCT00930813, which also lists 5 linked publications.

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 21 Dec 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in