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

Phase 1

Completed

Interventions: Device: Lutonix Catheter
Device: Standard uncoated Balloon Angioplasty Catheter

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Lutonix Catheter	Lutonix Catheter	Paclitaxel coated Balloon Catheter
Standard uncoated Balloon Angioplasty Catheter	Standard uncoated Balloon Angioplasty Catheter	uncoated angioplasty balloon

Primary Outcome Measures

Name	Time	Method
Angiographic Late Lumen Loss	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 Outcome Measures

Name	Time	Method
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	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	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	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

Locations (10): Sint Blasius
🇧🇪
Dendermonde, Belgium
St Katharenen Cardiovascular Center
🇩🇪
Frankfurt, Germany
Jewish Hospital
🇩🇪
Berlin, Germany
Hamburg Unversity Cardiovascular Center
🇩🇪
Hamburg, Germany
Herz Zentrum
🇩🇪
Bad Krozingen, Germany
Universitätsklinikum
🇩🇪
Magdeburg, Germany
St. Franziskus
🇩🇪
Muenster, Germany
Park Krankenhaus - University of Leipzig
🇩🇪
Leipzig, Germany
Klinikum Rosenheim
🇩🇪
Rosenheim, Germany
Katharinenhospital
🇩🇪
Stuttgart, Germany