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

  Show 66 Study Locations
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
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014