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.

C. R. Bard10 sites in 2 countries101 target enrollmentJune 2009

ConditionsAtherosclerosis Vascular Disease Arteriosclerosis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Atherosclerosis
Sponsor: C. R. Bard
Enrollment: 101
Locations: 10
Primary Endpoint: Angiographic Late Lumen Loss
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

December 2011

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

C. R. Bard

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

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