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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00930813
Recruitment Status : Completed
First Posted : July 2, 2009
Results First Posted : December 21, 2015
Last Update Posted : December 21, 2015
Information provided by (Responsible Party):
C. R. Bard

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.

Condition or disease Intervention/treatment Phase
Atherosclerosis Vascular Disease Arteriosclerosis Device: Lutonix Catheter Device: Standard uncoated Balloon Angioplasty Catheter Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : June 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Lutonix Catheter
Paclitaxel coated Balloon Catheter
Device: Lutonix Catheter
Paclitaxel Coated Balloon Catheter
Other Names:
  • DCB
  • Drug coated balloon

Active Comparator: Standard uncoated Balloon Angioplasty Catheter
uncoated angioplasty balloon
Device: Standard uncoated Balloon Angioplasty Catheter
plain, uncoated angioplasty balloon catheter

Primary Outcome Measures :
  1. Angiographic Late Lumen Loss [ Time Frame: 6 months ]
    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 :
  1. Safety - Device Related Adverse Events [ Time Frame: 30 days ]
  2. Primary Patency of Treated Segment [ Time Frame: 6, 12, 24 months ]
  3. Target Lesion Revascularization [ Time Frame: 6, 12, 24 months ]
  4. Target Vessel Revascularization [ Time Frame: 6, 12, 24 months ]
  5. Device Success [ Time Frame: at procedure ]
    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).

  6. Procedural Success [ Time Frame: at procedure ]
    Completion of the procedure with less than 30% residual stenosis by QVA of the target lesion (after prolonged dilation and stenting, if necessary)

  7. Change in Ankle-brachial Index [ Time Frame: pre-procedure, 6, 12 and 24 months ]
  8. Change in Walking Impairment Questionnaire (WIQ) [ Time Frame: pre-procedure, 6, 12 and 24 months ]
  9. Change in Rutherford Grade [ Time Frame: pre-procedure,6, 12 and 24 months ]
  10. Serum Paclitaxel Levels - in Subsets of Patients [ Time Frame: 0, 1, 3 hours and pre-discharge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00930813

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Sint Blasius
Dendermonde, Belgium
Herz Zentrum
Bad Krozingen, Germany
Jewish Hospital
Berlin, Germany
St Katharenen Cardiovascular Center
Frankfurt, Germany
Hamburg Unversity Cardiovascular Center
Hamburg, Germany
Park Krankenhaus - University of Leipzig
Leipzig, Germany
Magdeburg, Germany
St. Franziskus
Muenster, Germany
Klinikum Rosenheim
Rosenheim, Germany
Stuttgart, Germany
Sponsors and Collaborators
C. R. Bard

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: C. R. Bard Identifier: NCT00930813     History of Changes
Other Study ID Numbers: CL0012-01
First Posted: July 2, 2009    Key Record Dates
Results First Posted: December 21, 2015
Last Update Posted: December 21, 2015
Last Verified: November 2015
Keywords provided by C. R. Bard:
Drug coated balloon
SFA disease
Femoropopliteal disease
Tubulin modulators
Antineoplastic Agents
Mitosis Modulators
Balloon angioplasty
Local drug delivery
Drug-coated balloon
Additional relevant MeSH terms:
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Vascular Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action