LEVANT 2 Continued Access Registry

This study is enrolling participants by invitation only.

Sponsor:

Collaborator:

C. R. Bard

Information provided by (Responsible Party):

Lutonix, Inc.

ClinicalTrials.gov Identifier:

NCT01628159

First received: June 19, 2012

Last updated: February 3, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 19, 2012

Last Updated Date

February 3, 2013

Start Date ^ICMJE

June 2012

Estimated Primary Completion Date

June 2018 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01628159 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

LEVANT 2 Continued Access Registry

Official Title ^ICMJE

Continuation Registry of the Moxy Drug Coated Balloon for Treatment of Femoropopliteal Arteries (LEVANT 2 Continued Access Registry)

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Peripheral Artery Disease

Intervention ^ICMJE

Device: Moxy Drug Coated Balloon

Subject will receive treatment with the Moxy Drug Coated Balloon

Study Arm (s)

Experimental: Moxy Drug Coated Balloon

Paclitaxel coated balloon catheter

Intervention: Device: Moxy Drug Coated Balloon

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

975

Estimated Completion Date

June 2018

Estimated Primary Completion Date

June 2018 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Austria, Belgium, Germany, Switzerland

Administrative Information

NCT Number ^ICMJE

NCT01628159

Other Study ID Numbers ^ICMJE

CL0002-09

Has Data Monitoring Committee

Yes

Responsible Party

Lutonix, Inc.

Study Sponsor ^ICMJE

Lutonix, Inc.

Collaborators ^ICMJE

C. R. Bard

Investigators ^ICMJE

Principal Investigator:	Kenneth Rosenfield, MD	Massachusetts General Hospital
Principal Investigator:	Prof. Dierk Scheinert, MD	Park Krankenhaus

Information Provided By

Lutonix, Inc.

Verification Date

February 2013

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

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