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

NCT ID: NCT00930813

Last Updated: 2015-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-12-31

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.

Conditions

Atherosclerosis; Vascular Disease; Arteriosclerosis

Keywords

Drug coated balloon; SFA disease; Femoropopliteal disease; Angioplasty; PAD; Paclitaxel; Tubulin modulators; Antineoplastic Agents; Mitosis Modulators; Balloon angioplasty; Local drug delivery; Restenosis; Drug-coated balloon

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lutonix Catheter

Paclitaxel coated Balloon Catheter

Group Type: EXPERIMENTAL

Lutonix Catheter

Intervention Type: DEVICE

Paclitaxel Coated Balloon Catheter

Standard uncoated Balloon Angioplasty Catheter

uncoated angioplasty balloon

Group Type: ACTIVE_COMPARATOR

Standard uncoated Balloon Angioplasty Catheter

Intervention Type: DEVICE

plain, uncoated angioplasty balloon catheter

Interventions

Lutonix Catheter

Paclitaxel Coated Balloon Catheter

Intervention Type: DEVICE

Standard uncoated Balloon Angioplasty Catheter

plain, uncoated angioplasty balloon catheter

Intervention Type: DEVICE

Other Intervention Names

DCB; Drug coated balloon

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sint Blasius

Dendermonde, , Belgium

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

Münster, , Germany

Klinikum Rosenheim

Rosenheim, , Germany

Katharinenhospital

Stuttgart, , Germany

Countries

Belgium; Germany

References

Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008 Feb 14;358(7):689-99. doi: 10.1056/NEJMoa0706356.

Reference Type: BACKGROUND

PMID: 18272892 (View on PubMed)

Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008 Sep 23;118(13):1358-65. doi: 10.1161/CIRCULATIONAHA.107.735985. Epub 2008 Sep 8.

Reference Type: BACKGROUND

PMID: 18779447 (View on PubMed)

Ouriel K, Adelman MA, Rosenfield K, Scheinert D, Brodmann M, Pena C, Geraghty P, Lee A, White R, Clair DG. Safety of Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease. JACC Cardiovasc Interv. 2019 Dec 23;12(24):2515-2524. doi: 10.1016/j.jcin.2019.08.025. Epub 2019 Sep 28.

Reference Type: DERIVED

PMID: 31575518 (View on PubMed)

Scheinert D, Duda S, Zeller T, Krankenberg H, Ricke J, Bosiers M, Tepe G, Naisbitt S, Rosenfield K. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv. 2014 Jan;7(1):10-9. doi: 10.1016/j.jcin.2013.05.022.

Reference Type: DERIVED

PMID: 24456716 (View on PubMed)

Other Identifiers

CL0012-01

Identifier Type: -

Identifier Source: org_study_id