Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2015 by C. R. Bard

Sponsor:

Collaborator:

Bard Ltd

Information provided by (Responsible Party):

C. R. Bard

ClinicalTrials.gov Identifier:

NCT01870401

First received: May 7, 2013

Last updated: January 16, 2015

Last verified: January 2015

History of Changes

Purpose

To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of stenosis or occlusion of native below-the-knee arteries.

Condition	Intervention	Phase
Critical Limb Ischemia	Device: Lutonix DCB Device: Uncoated PTA Catheter	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Lutonix Drug Coated Balloon Versus Standard Balloon Angioplasty for Treatment of Below-the-Knee (BTK) Arteries(Lutonix BTK Trial)

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty

U.S. FDA Resources

Further study details as provided by C. R. Bard:

Primary Outcome Measures:

Freedom from BTK MALE+POD [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Composite of all-cause death, above-ankle amputation or major reintervention
Limb Salvage [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Freedom from the composite of above ankle amputation
Primary Patency [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Freedom from target vessel occlusion and clinically driven target lesion reintervention

Secondary Outcome Measures:

Wound healing [ Time Frame: 30 days; 6 months, 12 months, 24 months, and 36 months ] [ Designated as safety issue: No ]
Healed or not, if not, improving, stagnant, worsening
Primary Patency [ Time Frame: 30 days and at 6 months, 12 months, 24 months, and 36 months ] [ Designated as safety issue: No ]
Freedom from occlusion without clinically-driven Target Lesion Revascularization (TLR)
Hemodynamic outcome [ Time Frame: 30 days and at 6 months, 12 months, 24 months, and 36 months ] [ Designated as safety issue: No ]
change in toe & ankle pressures
Clinically-driven TLR [ Time Frame: 30 days and at 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
Revascularization performed on all randomized patients who returned with clinical symptoms, and if the subject has a target lesion diameter stenosis ≥ 50%.
Limb salvage in surviving subjects [ Time Frame: 30 days and at 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
No Amputation of target limb


Estimated Enrollment:	480
Study Start Date:	May 2013
Estimated Study Completion Date:	September 2019
Estimated Primary Completion Date:	September 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Lutonix DCB Lutonix Paclitaxel Drug Coated Balloon	Device: Lutonix DCB Other Name: LTX DCB
Active Comparator: PTA Catheter Standard Uncoated Balloon Angioplasty Catheter	Device: Uncoated PTA Catheter Other Name: PTA

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 4-5;
Life expectancy ≥ 1 year;
Significant stenosis (≥70%)
A patent inflow artery;
Target vessel(s) diameter between 2 and 4 mm;
Target vessel(s) reconstitute(s) at or above the ankle

Exclusion Criteria:

Pregnant or planning on becoming pregnant;
History of stroke within 3 months;
History of MI, thrombolysis or angina within 30 days of enrollment;
Prior or planned major amputation;
GFR ≤ 30 ml/min per 1.73m2;
Acute limb ischemia;
In-stent restenosis of target lesion

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: NCT01870401

Contacts


Contact: Robert M Jardin		LutonixResearch@crbard.com

Show 57 Study Locations

Sponsors and Collaborators

C. R. Bard

Bard Ltd

Investigators


Principal Investigator:	Patrick Geraghty, MD	Washington University School of Medicine
Principal Investigator:	Jihad Mustapha, MD	Metro Health Hospital
Principal Investigator:	Marianne Brodmann, MD	Medical University Graz, Austria

More Information

No publications provided


Responsible Party:	C. R. Bard
ClinicalTrials.gov Identifier:	NCT01870401 History of Changes
Other Study ID Numbers:	CL0005-01
Study First Received:	May 7, 2013
Last Updated:	January 16, 2015
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on February 27, 2015

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