Clinical trial NCT00930813: LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
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
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2009-07-02
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Angiographic Late Lumen Loss
timeFrame: 6 months
Secondary outcomes:
measure: Safety - Device Related Adverse Events
timeFrame: 30 days
measure: Primary Patency of Treated Segment
timeFrame: 6, 12, 24 months
measure: Target Lesion Revascularization
timeFrame: 6, 12, 24 months
measure: Target Vessel Revascularization
timeFrame: 6, 12, 24 months
measure: Device Success
timeFrame: at procedure
measure: Procedural Success
timeFrame: at procedure
measure: Change in Ankle-brachial Index
timeFrame: pre-procedure, 6, 12 and 24 months
measure: Change in Walking Impairment Questionnaire (WIQ)
timeFrame: pre-procedure, 6, 12 and 24 months
measure: Change in Rutherford Grade
timeFrame: pre-procedure,6, 12 and 24 months
measure: Serum Paclitaxel Levels - in Subsets of Patients
timeFrame: 0, 1, 3 hours and pre-discharge
Other outcomes:
Locations:
city: Dendermonde
country: Belgium
facility: Sint Blasius
city: Bad Krozingen
country: Germany
facility: Herz Zentrum
city: Berlin
country: Germany
facility: Jewish Hospital
city: Frankfurt
country: Germany
facility: St Katharenen Cardiovascular Center
city: Hamburg
country: Germany
facility: Hamburg Unversity Cardiovascular Center
city: Leipzig
country: Germany
facility: Park Krankenhaus - University of Leipzig
city: Magdeburg
country: Germany
facility: Universitätsklinikum
city: Muenster
country: Germany
facility: St. Franziskus
city: Rosenheim
country: Germany
facility: Klinikum Rosenheim
city: Stuttgart
country: Germany
facility: Katharinenhospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.