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

C. R. Bard

Status and phase

Completed

Phase 2

Phase 1

Conditions

Vascular Disease

Arteriosclerosis

Atherosclerosis

Treatments

Device: Lutonix Catheter

Device: Standard uncoated Balloon Angioplasty Catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT00930813

CL0012-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

101 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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