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

Atherosclerosis Clinical Trial

— LEVANT I  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930813
• Other study ID #: CL0012-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 30, 2009
• Last updated: November 17, 2015
• Start date: June 2009
• Est. completion date: December 2011

Study information

• Verified date: November 2015
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriosclerosis
• Atherosclerosis
• Vascular Disease
• Vascular Diseases

Intervention

Device:
• Lutonix Catheter
Paclitaxel Coated Balloon Catheter
• Standard uncoated Balloon Angioplasty Catheter
plain, uncoated angioplasty balloon catheter

Locations

Country	Name	City	State
Belgium	Sint Blasius	Dendermonde
Germany	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	Muenster
Germany	Klinikum Rosenheim	Rosenheim
Germany	Katharinenhospital	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Countries where clinical trial is conducted

Belgium,  Germany, 

References & Publications (2)

Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwälder 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. — View 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. Erratum in: Circulation. 2008 Oct 14;118(16):e670. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic Late Lumen Loss	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.	6 months	No
Secondary	Safety - Device Related Adverse Events		30 days	Yes
Secondary	Primary Patency of Treated Segment		6, 12, 24 months	No
Secondary	Target Lesion Revascularization		6, 12, 24 months	No
Secondary	Target Vessel Revascularization		6, 12, 24 months	No
Secondary	Device Success	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).	at procedure	No
Secondary	Procedural Success	Completion of the procedure with less than 30% residual stenosis by QVA of the target lesion (after prolonged dilation and stenting, if necessary)	at procedure	No
Secondary	Change in Ankle-brachial Index		pre-procedure, 6, 12 and 24 months	No
Secondary	Change in Walking Impairment Questionnaire (WIQ)		pre-procedure, 6, 12 and 24 months	No
Secondary	Change in Rutherford Grade		pre-procedure,6, 12 and 24 months	No
Secondary	Serum Paclitaxel Levels - in Subsets of Patients		0, 1, 3 hours and pre-discharge	No