LEVANT 2 Safety Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01790243
Recruitment Status : Active, not recruiting
First Posted : February 13, 2013
Last Update Posted : November 17, 2017
Information provided by (Responsible Party):
C. R. Bard

Brief Summary:
The purpose of the study is to collect additional safety and efficacy information on the Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the femoral and popliteal arteries.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Device: Lutonix Drug Coated Balloon Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Registry of the Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries (LEVANT 2 Safety Registry)
Study Start Date : February 2013
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Experimental: Lutonix Drug Coated Balloon
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

Primary Outcome Measures :
  1. Unanticipated device- or drug- related adverse events [ Time Frame: 60 months ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: 1, 6, 12, 24, 36, 48, 60 ]
    • Composite of freedom from all-cause perioperative (≤ 30 day) death and freedom from the following at 1, 6, 12, 24, 36, 48, and 60 months: index limb amputation, index limb re-intervention, and index-limb-related death
    • Freedom at 30 days from all-cause death, index limb amputation above the ankle and target vessel revascularization (TVR) (VIVA Safety Endpoint)

  2. Efficacy [ Time Frame: 6, 12 and 24 months ]
    Acute device, technical and procedural success

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Clinical Inclusion Criteria:

  1. Male or non-pregnant female ≥18 years of age;
  2. Rutherford Clinical Category 2-4;
  3. Patient is willing to provide informed consent, is geographically stable and comply with the required follow up visits, testing schedule and medication regimen;

    Angiographic Lesion Inclusion Criteria:

  4. Length ≤15 cm;
  5. 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);
  6. ≥70% stenosis by visual estimate;
  7. 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;
  8. de novo lesion(s) or non-stented restenotic lesion(s) >90 days from prior angioplasty procedure;
  9. Lesion is located at least 3 cm from any stent, if target vessel was previously stented;
  10. Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix;
  11. Successful, uncomplicated (without use of a crossing device) antegrade wire crossing of lesion;
  12. 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.
  13. 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);
  14. 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;
  15. No other prior vascular interventions within 2 weeks before and/or planned 30 days after the protocol treatment.

Exclusion Criteria:

Patients will be excluded if ANY of the following conditions apply:

  1. Pregnant or planning on becoming pregnant or men intending to father children;
  2. Life expectancy of <5 years;
  3. 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.
  4. History of hemorrhagic stroke within 3 months;
  5. Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure;
  6. History of MI, thrombolysis or angina within 2 weeks of enrollment;
  7. Rutherford Class 0, 1, 5 or 6;
  8. 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);
  9. 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;
  10. Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication;
  11. Anticipated use of IIb/IIIa inhibitor prior to randomization;
  12. Ipsilateral retrograde access;
  13. Composite lesion length is >15 cm or there is no normal proximal arterial segment in which duplex flow velocity can be measured;
  14. Significant inflow disease. Successful treatment of inflow disease allowed prior to target lesion treatment;
  15. Known inadequate distal outflow (>50 % stenosis of distal popliteal and/or all three tibial vessels), or planned future treatment of vascular disease distal to the target lesion;
  16. Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel;
  17. Severe calcification that renders the lesion un-dilatable;
  18. Use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01790243

United States, California
Mission Cardiovascular Research Institute
Fremont, California, United States, 94538
United States, Michigan
Metro Health Hospital
Wyoming, Michigan, United States, 49519
United States, Mississippi
Jackson Heart Clinic/St. Dominic's Hospital
Jackson, Mississippi, United States, 39216
United States, Missouri
Mercy Hospital
Springfield, Missouri, United States, 65804
United States, New Jersey
Holy Name Medical Center
Teaneck, New Jersey, United States, 07666
United States, New York
New York Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States, 10021
United States, Ohio
TriHealth Heart Institute
Cincinnati, Ohio, United States, 45220
United States, Texas
Mission Research Institute
New Braunfels, Texas, United States, 78130
Sponsors and Collaborators
C. R. Bard
Principal Investigator: Kenneth Rosenfield, MD Massachusetts General Hospital

Responsible Party: C. R. Bard Identifier: NCT01790243     History of Changes
Other Study ID Numbers: CL0006-01
First Posted: February 13, 2013    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Peripheral Arterial Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases