LEVANT 2 Continued Access Registry

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT01628159
First received: June 19, 2012
Last updated: March 10, 2015
Last verified: March 2015
  Purpose

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 Intervention
Peripheral Artery Disease
Device: Lutonix Drug Coated Balloon

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, LEVANT 2 Continuation Registry of the Moxy™ Drug Coated Balloon for Treatment of Femoropopliteal Arteries

Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • Unanticipated device- or drug- related adverse events [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 1, 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: Yes ]
    • 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)

  • Efficacy [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Acute device, technical and procedural success


Enrollment: 675
Study Start Date: June 2012
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01628159

  Hide Study Locations
Locations
United States, California
Good Samaritan Hospital
Los Angeles, California, United States, 90017
North County Radiology Medial Group Inc.
Oceanside, California, United States, 92056
St. Joseph's Hospital
Orange, California, United States, 92868
University of California Davis
Sacramento, California, United States, 95817
United States, Colorado
Medical Center of the Rockies
Loveland, Colorado, United States, 80538
United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Washington Cardiology Center
Washington, District of Columbia, United States, 20010
United States, Florida
Heart and Vascular Institute
Clearwater, Florida, United States, 33756
Interventional Cardiolgists of Gainesville
Gainesville, Florida, United States, 32605
Munroe Regional Medical Center
Ocala, Florida, United States, 34471
United States, Illinois
Cardiovascular Associates
Elk Grove Village, Illinois, United States, 60007
Edward Heart / Midwest Research Foundation
Oak Brook Terrace, Illinois, United States, 60181
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
St. John's Hosptial
Springfield, Illinois, United States, 62710
United States, Indiana
Allen County Cardiology
Fort Wayne, Indiana, United States, 46802
St. Vincent Heart Center of Indianapolis
Indianapolis, Indiana, United States, 46290
United States, Iowa
The Iowa Clinic
West Des Moines, Iowa, United States, 50266
United States, Kansas
Promise Regional Medical Center
Hutchinson, Kansas, United States, 67502
St. Francis Heart & Vascular Center
Topeka, Kansas, United States, 66606
United States, Massachusetts
Massachusetts Genearl Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Detroit Medical Center
Detroit, Michigan, United States, 48201
St. John's Hospital
Detroit, Michigan, United States, 48236
Michigan Heart
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
Mercy Hosptial
Coon Rapids, Minnesota, United States, 55433
United States, Mississippi
Forrest General Hospital
Hattiesburg, Mississippi, United States, 39401
United States, New Jersey
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States, 08015
Our Lady of Lourdes Medical Center
Cherry Hill, New Jersey, United States, 08034
United States, New York
Columbia Universtiy Medical Center
New York, New York, United States, 10032
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, North Carolina
Wake Heart and Vascular
Raleigh, North Carolina, United States, 27610
United States, Ohio
Christ Hospital / The Lindner Clinical Trial Center
Cincinnati, Ohio, United States, 45219
Case Medical Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Mid Ohio Cardiology and Vascular Consultants
Columbus, Ohio, United States, 43214
Jobst Vascular Institute
Toledo, Ohio, United States, 43606
Univesrity of Toledo Medical Center
Toledo, Ohio, United States, 43614
United States, South Carolina
Greenville Memorial Hospital
Greenville, South Carolina, United States, 29615
United States, Tennessee
Wellmont Cardiology Services
Kingsport, Tennessee, United States, 37660
East Tennessee Heart Consultants
Knoxville, Tennessee, United States, 37934
United States, Texas
Austin Heart P.A.
Austin, Texas, United States, 78705
Austria
Medizinishe Univeristaet Graz
Graz, Austria
Klinikum Klagenfurt
Klagenfurt, Austria
Belgium
OLV Zieckenhuis
Aalst, Belgium
Imelda Ziekenhuis
Bonheiden, Belgium
Flanders Medical Research Program
Dendermonde, Belgium
Hospital Oost-Limburg
Genk, Belgium
Ghent University Hospital
Ghent, Belgium
Germany
Herz-Zentrum
Bad Krozingen, Germany
Jewish Hospital
Berlin, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Germany
Diakonissenanstalt zu Flensburg
Flensburg, Germany
Hamburg University Cardiovascular Center
Hamburg, Germany
University Clinical Center Heidelberg
Heidelberg, Germany
Herz-Und Gefasszentrum
Immenstadt, Germany
Practice for Interventional Radiology
Kaiserslautern, Germany
Westpfalz Clinic
Kusen, Germany
University Leipzig
Leipzig, Germany
University Magdeburg
Magdeburg, Germany
Universtiy Clinic Muenster
Muenster, Germany
University of Munich
Munich, Germany
Ernst von Bergham Clinic
Potstdam, Germany
University of Tübingen
Tübingen, Germany
Switzerland
University Hospital
Bern, Switzerland
Canton Hospital Lucerne
Lucerne, Switzerland
University Hospital, Zurich
Zurich, Switzerland
Sponsors and Collaborators
C. R. Bard
Investigators
Principal Investigator: Kenneth Rosenfield, MD Massachusetts General Hospital
Principal Investigator: Prof. Dierk Scheinert, MD University Leipzig
  More Information

No publications provided

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01628159     History of Changes
Other Study ID Numbers: CL0002-09
Study First Received: June 19, 2012
Last Updated: March 10, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 01, 2015