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

Primary Purpose

Atherosclerosis, Vascular Disease, Arteriosclerosis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Lutonix Catheter
Standard uncoated Balloon Angioplasty Catheter
Sponsored by
C. R. Bard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Sint Blasius
  • Herz Zentrum
  • Jewish Hospital
  • St Katharenen Cardiovascular Center
  • Hamburg Unversity Cardiovascular Center
  • Park Krankenhaus - University of Leipzig
  • Universitätsklinikum
  • St. Franziskus
  • Klinikum Rosenheim
  • Katharinenhospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lutonix Catheter

Standard uncoated Balloon Angioplasty Catheter

Arm Description

Paclitaxel coated Balloon Catheter

uncoated angioplasty balloon

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Safety - Device Related Adverse Events
Primary Patency of Treated Segment
Target Lesion Revascularization
Target Vessel Revascularization
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).
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)
Change in Ankle-brachial Index
Change in Walking Impairment Questionnaire (WIQ)
Change in Rutherford Grade
Serum Paclitaxel Levels - in Subsets of Patients

Full Information

First Posted
June 30, 2009
Last Updated
November 17, 2015
Sponsor
C. R. Bard
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1. Study Identification

Unique Protocol Identification Number
NCT00930813
Brief Title
LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis
Acronym
LEVANT I
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
C. R. Bard

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Vascular Disease, Arteriosclerosis
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lutonix Catheter
Arm Type
Experimental
Arm Description
Paclitaxel coated Balloon Catheter
Arm Title
Standard uncoated Balloon Angioplasty Catheter
Arm Type
Active Comparator
Arm Description
uncoated angioplasty balloon
Intervention Type
Device
Intervention Name(s)
Lutonix Catheter
Other Intervention Name(s)
DCB, Drug coated balloon
Intervention Description
Paclitaxel Coated Balloon Catheter
Intervention Type
Device
Intervention Name(s)
Standard uncoated Balloon Angioplasty Catheter
Intervention Description
plain, uncoated angioplasty balloon catheter
Primary Outcome Measure Information:
Title
Angiographic Late Lumen Loss
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Safety - Device Related Adverse Events
Time Frame
30 days
Title
Primary Patency of Treated Segment
Time Frame
6, 12, 24 months
Title
Target Lesion Revascularization
Time Frame
6, 12, 24 months
Title
Target Vessel Revascularization
Time Frame
6, 12, 24 months
Title
Device Success
Description
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).
Time Frame
at procedure
Title
Procedural Success
Description
Completion of the procedure with less than 30% residual stenosis by QVA of the target lesion (after prolonged dilation and stenting, if necessary)
Time Frame
at procedure
Title
Change in Ankle-brachial Index
Time Frame
pre-procedure, 6, 12 and 24 months
Title
Change in Walking Impairment Questionnaire (WIQ)
Time Frame
pre-procedure, 6, 12 and 24 months
Title
Change in Rutherford Grade
Time Frame
pre-procedure,6, 12 and 24 months
Title
Serum Paclitaxel Levels - in Subsets of Patients
Time Frame
0, 1, 3 hours and pre-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 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
Facility Information:
Facility Name
Sint Blasius
City
Dendermonde
Country
Belgium
Facility Name
Herz Zentrum
City
Bad Krozingen
Country
Germany
Facility Name
Jewish Hospital
City
Berlin
Country
Germany
Facility Name
St Katharenen Cardiovascular Center
City
Frankfurt
Country
Germany
Facility Name
Hamburg Unversity Cardiovascular Center
City
Hamburg
Country
Germany
Facility Name
Park Krankenhaus - University of Leipzig
City
Leipzig
Country
Germany
Facility Name
Universitätsklinikum
City
Magdeburg
Country
Germany
Facility Name
St. Franziskus
City
Muenster
Country
Germany
Facility Name
Klinikum Rosenheim
City
Rosenheim
Country
Germany
Facility Name
Katharinenhospital
City
Stuttgart
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
18272892
Citation
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.
Results Reference
background
PubMed Identifier
18779447
Citation
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. Erratum In: Circulation. 2008 Oct 14;118(16):e670.
Results Reference
background
PubMed Identifier
31575518
Citation
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.
Results Reference
derived
PubMed Identifier
24456716
Citation
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.
Results Reference
derived

Learn more about this trial

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

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