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

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ClinicalTrials.gov Identifier: NCT00930813
Recruitment Status : Completed
First Posted : July 2, 2009
Results First Posted : December 21, 2015
Last Update Posted : December 21, 2015
Sponsor:
Information provided by (Responsible Party):
C. R. Bard

Tracking Information
First Submitted Date  ICMJE June 30, 2009
First Posted Date  ICMJE July 2, 2009
Results First Submitted Date  ICMJE August 5, 2014
Results First Posted Date  ICMJE December 21, 2015
Last Update Posted Date December 21, 2015
Study Start Date  ICMJE June 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 30, 2009)
Angiographic Late Lumen Loss [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT00930813 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2013)
  • Safety - Device Related Adverse Events [ Time Frame: 30 days ]
  • Primary Patency of Treated Segment [ Time Frame: 6, 12, 24 months ]
  • Target Lesion Revascularization [ Time Frame: 6, 12, 24 months ]
  • Target Vessel Revascularization [ Time Frame: 6, 12, 24 months ]
  • 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).
  • 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)
  • Change in Ankle-brachial Index [ Time Frame: pre-procedure, 6, 12 and 24 months ]
  • Change in Walking Impairment Questionnaire (WIQ) [ Time Frame: pre-procedure, 6, 12 and 24 months ]
  • Change in Rutherford Grade [ Time Frame: pre-procedure,6, 12 and 24 months ]
  • Serum Paclitaxel Levels - in Subsets of Patients [ Time Frame: 0, 1, 3 hours and pre-discharge ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2009)
  • Safety - Device Related Adverse Events [ Time Frame: 30 days ]
  • Primary Patency of Treated Segment [ Time Frame: 6, 12, 24 months ]
  • Target Lesion Revascularization [ Time Frame: 6, 12, 24 months ]
  • Target Vessel Revascularization [ Time Frame: 6, 12, 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Atherosclerosis
  • Vascular Disease
  • Arteriosclerosis
Intervention  ICMJE
  • Device: Lutonix Catheter
    Paclitaxel Coated Balloon Catheter
    Other Names:
    • DCB
    • Drug coated balloon
  • Device: Standard uncoated Balloon Angioplasty Catheter
    plain, uncoated angioplasty balloon catheter
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2009)
101
Original Estimated Enrollment  ICMJE
 (submitted: June 30, 2009)
100
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00930813
Other Study ID Numbers  ICMJE CL0012-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party C. R. Bard
Study Sponsor  ICMJE C. R. Bard
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account C. R. Bard
Verification Date November 2015

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