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
  Purpose

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 Intervention Phase
Atherosclerosis
Vascular Disease
Arteriosclerosis
Device: Lutonix Catheter
Device: Standard uncoated Balloon Angioplasty Catheter
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:


Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • Angiographic late lumen loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 101
Study Start Date: June 2009
Study Completion Date: December 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 femropopliteal arteries. Patients will be randomized to treatment with either the Lutonix Catheter or standard balloon angioplasty after predilation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930813

Locations
Belgium
Sint Blasius
Dendermonde, Belgium
Germany
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
Universitätsklinikum
Magdeburg, Germany
St. Franziskus
Muenster, Germany
Klinikum Rosenheim
Rosenheim, Germany
Katharinenhospital
Stuttgart, Germany
Sponsors and Collaborators
C. R. Bard
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT00930813     History of Changes
Other Study ID Numbers: CL0012-01
Study First Received: June 30, 2009
Last Updated: December 18, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by C. R. Bard:
Drug coated balloon
SFA disease
Femoropopliteal disease
Angioplasty
PAD
Paclitaxel
Tubulin modulators
Antineoplastic Agenents
Mitosis Modulators
Balloon angioplasty
Local drug delivery
Restenosis
Drug-coated balloon

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Vascular Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014