Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

LEVANT 2 Safety Registry

This study is ongoing, but not recruiting participants.
Bard Ltd
Information provided by (Responsible Party):
C. R. Bard Identifier:
First received: February 8, 2013
Last updated: November 22, 2013
Last verified: November 2013

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 Phase
Peripheral Artery Disease
Device: Lutonix Drug Coated Balloon
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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)

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, 60 ] [ Designated as safety issue: No ]
    Freedom from death, amputation or limb reintervention; Composite of freedom from all-cause perioperative death.

Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Device: Lutonix Drug Coated Balloon


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

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 identifier: NCT01790243

United States, California
Mission Cardiovascular Research Institute
Fremont, California, United States, 94538
United States, Michigan
Mid-Michigan Heart and Vascular Center, P.C.
Saginaw, Michigan, United States, 48604
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
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
United States, Texas
Mission Research Institute
New Braunfels, Texas, United States, 78130
Sponsors and Collaborators
C. R. Bard
Bard Ltd
Principal Investigator: Kenneth Rosenfield, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: C. R. Bard Identifier: NCT01790243     History of Changes
Other Study ID Numbers: CL0006-03
Study First Received: February 8, 2013
Last Updated: November 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peripheral Arterial Disease
Arterial Occlusive Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Vascular Diseases processed this record on March 03, 2015