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LEVANT 2 Safety Registry

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Bard Ltd
Information provided by (Responsible Party):
Lutonix, Inc.
ClinicalTrials.gov Identifier:
NCT01790243
First received: February 8, 2013
Last updated: February 11, 2013
Last verified: February 2013
History of Changes

February 8, 2013
February 11, 2013
February 2013
September 2018   (final data collection date for primary outcome measure)
Unanticipated device- or drug- related adverse events [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01790243 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
LEVANT 2 Safety Registry
A Prospective, Multicenter, Registry of the Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries (LEVANT 2 Safety Registry)

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
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Peripheral Artery Disease
Device: Lutonix Drug Coated Balloon
Experimental: Single Arm
Intervention: Device: Lutonix Drug Coated Balloon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
100
September 2018
September 2018   (final data collection date for primary outcome measure)

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.)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01790243
CL0006-03
No
Lutonix, Inc.
Lutonix, Inc.
Bard Ltd
Principal Investigator: Kenneth Rosenfield, MD Massachusetts General Hospital
Lutonix, Inc.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP