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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT00930813
First received: June 30, 2009
Last updated: December 18, 2013
Last verified: December 2013

June 30, 2009
December 18, 2013
June 2009
June 2010   (final data collection date for primary outcome measure)
Angiographic late lumen loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00930813 on ClinicalTrials.gov Archive Site
  • Safety - Device related adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Primary patency of treated segment [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Target Lesion Revascularization [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Device Success [ Time Frame: at procedure ] [ Designated as safety issue: No ]
    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 [ Time Frame: at procedure ] [ Designated as safety issue: No ]
    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 [ Time Frame: pre-procedure, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Change in Walking Impairment Questionnaire (WIQ) [ Time Frame: pre-procedure, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Change in Rutherford Grade [ Time Frame: pre-procedure,6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Serum paclitaxel levels - in subsets of patients [ Time Frame: 0, 1, 3 hours and pre-discharge ] [ Designated as safety issue: No ]
  • Safety - Device related adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Primary patency of treated segment [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Target Lesion Revascularization [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropoliteal Restenosis
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.

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

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Atherosclerosis
  • Vascular Disease
  • Arteriosclerosis
  • Device: Lutonix Catheter
    Paclitaxel Coated Balloon Catheter
    Other Names:
    • DCB
    • Drug coated balloon
  • Device: Standard uncoated Balloon Angioplasty Catheter
    plain, uncoated angioplasty balloon catheter
  • Experimental: Lutonix Catheter
    Paclitaxel coated Balloon Catheter
    Intervention: Device: Lutonix Catheter
  • Active Comparator: Standard uncoated Balloon Angioplasty Catheter
    uncoated angioplasty balloon
    Intervention: Device: Standard uncoated Balloon Angioplasty Catheter

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
December 2011
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Belgium
 
NCT00930813
CL0012-01
Yes
C. R. Bard
C. R. Bard
Not Provided
Not Provided
C. R. Bard
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP