LEVANT 2 Safety Registry

NCT01790243 | Completed Results

• 1 other identifier: CL0006-01
• Study Type: interventional
• Target: 1,189
• Locations: 1 country
• Sites: 8

Brief Summary

The primary objective of the LEVANT 2 Extended Follow-up Post-Approval Study (PAS 1) is to evaluate the long-term performance of the Lutonix Drug Coated Balloon (DCB) versus Percutaneous Transluminal Balloon Angioplasty (PTA) in the treatment of stenosis or occlusion of the femoropopliteal arteries.

Conditions

Peripheral Artery Disease; Femoropopliteal Artery Occlusion; Femoropopliteal Stenosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Unanticipated Device- or Drug-Related Serious Adverse Events at 60 Months Post Index Procedure.

  From index procedure to 60 months Post Index Procedure

Secondary Outcomes (9)

• Number of Subjects With Freedom From Death, Index-Limb Amputation, and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure

  30 days post index procedure

• Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure

  1, 6, 12, 24, 36, 48, and 60 months post index procedure (PPI)

• Percentage of Participants With Primary Patency of the Target Lesion at 6, 12, and 24 Months Post Index Procedure

  6, 12, and 24 months post index procedure

• Number of Acute Device Success at Time of Index Procedure

  At time of index procedure

• Number of Participants With Technical and Procedural Success

  At time of index procedure

Study Arms (2)

Lutonix Drug Coated Balloon

EXPERIMENTAL

Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter

Device: Lutonix Drug Coated Balloon

Standard Uncoated Angioplasty Balloon

ACTIVE COMPARATOR

PTA Catheter

Device: Standard PTA Balloon

Interventions

Lutonix Drug Coated Balloon DEVICE

Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries.

Lutonix Drug Coated Balloon

Standard PTA Balloon DEVICE

Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries.

Standard Uncoated Angioplasty Balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant female ≥18 years of age;
• Rutherford Clinical Category 2-4;
• Patient is willing to provide informed consent, is geographically stable and comply with the required follow up visits, testing schedule and medication regimen;
• Length ≤15 cm;
• Up to two focal lesions or segments within the designated 15 cm length of vessel may be treated (e.g. two discrete segments, separated by several cm, but both falling within a composite length of \<15 cm);
• ≥70% stenosis by visual estimate;
• Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the TP trunk;
• De novo lesion(s) or non-stented restenotic lesion(s) \>90 days from prior angioplasty procedure;
• Lesion is located at least 3 cm from any stent, if target vessel was previously stented;
• Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix;
• Successful, uncomplicated (without use of a crossing device) antegrade 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); NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤30% without death or major vascular complication.
• At least one patent native outflow artery to the ankle, free from significant (≥50%) stenosis as confirmed by angiography that has not previously been revascularized (treatment of outflow disease is NOT permitted during the index procedure);
• Contralateral limb lesion(s) cannot be treated within 2 weeks before and/or planned 30 days after the protocol treatment in order to avoid confounding complications;
• No other prior vascular interventions within 2 weeks before and/or planned 30 days after the protocol treatment.

You may not qualify if:

• Patients will be excluded if ANY of the following conditions apply:
• Pregnant or planning on becoming pregnant or men intending to father children;
• Life expectancy of \<5 years;
• Patient is currently participating in an investigational drug or other device study or previously enrolled in this study; NOTE: Enrollment in another clinical trial during the follow up period is not allowed.
• History of hemorrhagic stroke within 3 months;
• Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure;
• History of MI, thrombolysis or angina within 2 weeks of enrollment;
• Rutherford Class 0, 1, 5 or 6;
• Renal failure or chronic kidney disease with MDRD GFR ≤30 ml/min per 1.73 m2 (or serum creatinine ≥2.5 mg/L within 30 days of index procedure or treated with dialysis);
• Prior vascular surgery of the index limb, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion;
• Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication;
• Anticipated use of IIb/IIIa inhibitor prior to randomization;
• Ipsilateral retrograde access;
• Composite lesion length is \>15 cm or there is no normal proximal arterial segment in which duplex flow velocity can be measured;
• Significant inflow disease. Successful treatment of inflow disease allowed prior to target lesion treatment;

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (8)

Mission Cardiovascular Research Institute

Fremont, California, 94538, United States

Location

Metro Health Hospital

Wyoming, Michigan, 49519, United States

Location

Jackson Heart Clinic/St. Dominic's Hospital

Jackson, Mississippi, 39216, United States

Location

Mercy Hospital

Springfield, Missouri, 65804, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

New York Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, 10021, United States

Location

TriHealth Heart Institute

Cincinnati, Ohio, 45220, United States

Location

Mission Research Institute

New Braunfels, Texas, 78130, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Anna Lovas
• Organization: Becton Dickinson

anna.lovas@bd.com

7634452382

Study Officials

• Kenneth Rosenfield, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2013
• First Posted: February 13, 2013
• Study Start: July 20, 2011
• Primary Completion: November 27, 2015
• Study Completion: November 1, 2018
• Last Updated: June 5, 2020
• Results First Posted: June 5, 2020

Record last verified: 2020-05

Locations

US (8)