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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: November 19, 2013
Last verified: November 2013
  Purpose

The purpose of the study is to collect additional safety and efficacy information on the Moxy Drug Coated Balloon for treatment of stenosis or occlusion of the femoral and popliteal arteries.


Condition Intervention Phase
Peripheral Artery Disease
Device: Moxy Drug Coated Balloon
Phase 2

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

Resource links provided by NLM:


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: No ]
    Freedom from death, amputation or limb reintervention; Composite of freedom from all-cause perioperative death amputation, re-intervention, and limb-related death

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


Estimated Enrollment: 975
Study Start Date: June 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Moxy Drug Coated Balloon
Paclitaxel coated balloon catheter
Device: Moxy Drug Coated Balloon
Subject will receive treatment with the Moxy Drug Coated Balloon

  Eligibility

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

Inclusion Criteria:

  • 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
  • ≥ 70% stenosis by visual estimate
  • de novo lesion(s) or non-stented restenotic lesion(s) > 90 days from prior angioplasty procedure
  • Target vessel diameter between ≥ 4 and ≤ 6 mm
  • Successful, uncomplicated (without use of a crossing device) antegrade wire crossing of lesion
  • No other prior vascular interventions within 2 weeks before and/or planned 30 days after the protocol treatment

Exclusion Criteria:

  • 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
  • History of hemorrhagic stroke within 3 months
  • Renal failure or chronic kidney disease
  • 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
  • Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel
  • 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
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
United States, Iowa
Methodist Medical Center
Des Moins, Iowa, United States, 50309
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
New York University Medical Center
New York, New York, United States, 10010
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
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Case Medical Center
Cleveland, Ohio, United States, 44106
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
Baptist DeSoto in Southaven
Memphis, Tennessee, United States, 38120
United States, Texas
Austin Heart P.A.
Austin, Texas, United States, 78705
Austria
Medizinishe Univeristaet Graz
Graz, Austria
Universtiy Medical Center Vienna
Vienna, 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
Practice for Interventional Radiology
Kaiserslautern, Germany
Westpfalz Clinic
Kusen, Germany
Heart Center Leipzig/Park Hospital
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
Regional Hospital of Lugano
Lugano, 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 Park Krankenhaus
  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: November 19, 2013
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 November 25, 2014