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

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.

Study Overview

• Status: Completed
• Conditions: Arteriosclerosis; Atherosclerosis; Vascular Disease
• Intervention / Treatment: Device: Lutonix Catheter; Device: Standard uncoated Balloon Angioplasty Catheter

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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Dendermonde, Belgium
    • Sint Blasius
• Germany
  • Bad Krozingen, Germany
    • Herz Zentrum
  • Berlin, Germany
    • Jewish Hospital
  • Frankfurt, Germany
    • St Katharenen Cardiovascular Center
  • Hamburg, Germany
    • Hamburg Unversity Cardiovascular Center
  • Leipzig, Germany
    • Park Krankenhaus - University of Leipzig
  • Magdeburg, Germany
    • Universitätsklinikum
  • Muenster, Germany
    • St. Franziskus
  • Rosenheim, Germany
    • Klinikum Rosenheim
  • Stuttgart, Germany
    • Katharinenhospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lutonix Catheter; Paclitaxel coated Balloon Catheter	Device: Lutonix Catheter; Paclitaxel Coated Balloon Catheter; Other Names: Drug coated balloon; DCB
Active Comparator: Standard uncoated Balloon Angioplasty Catheter; uncoated angioplasty balloon	Device: Standard uncoated Balloon Angioplasty Catheter; plain, uncoated angioplasty balloon catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	at procedure
Target Lesion Revascularization		6, 12, 24 months
Safety - Device Related Adverse Events		30 days
Primary Patency of Treated Segment		6, 12, 24 months
Target Vessel Revascularization		6, 12, 24 months
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)	at procedure
Change in Ankle-brachial Index		pre-procedure, 6, 12 and 24 months
Change in Walking Impairment Questionnaire (WIQ)		pre-procedure, 6, 12 and 24 months
Change in Rutherford Grade		pre-procedure,6, 12 and 24 months
Serum Paclitaxel Levels - in Subsets of Patients		0, 1, 3 hours and pre-discharge

Collaborators and Investigators

• Sponsor: C. R. Bard

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: June 30, 2009
• First Submitted That Met QC Criteria: June 30, 2009
• First Posted (Estimate): July 2, 2009

Study Record Updates

• Last Update Posted (Estimate): December 21, 2015
• Last Update Submitted That Met QC Criteria: November 17, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: PAD; Angioplasty; Antineoplastic Agents; Paclitaxel; Restenosis; Mitosis Modulators; Drug-coated balloon; Drug coated balloon; Balloon angioplasty; SFA disease; Femoropopliteal disease; Tubulin modulators; Local drug delivery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arterial Occlusive Diseases; Vascular Diseases; Arteriosclerosis; Atherosclerosis
• Other Study ID Numbers: CL0012-01