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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Critical Limb Ischemia	Device: Lutonix DCB; Device: Uncoated PTA Catheter	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	442 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
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)
Actual Study Start Date :	June 3, 2013
Estimated Primary Completion Date :	July 12, 2018
Estimated Study Completion Date :	June 2020

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Lutonix DCB; Lutonix Paclitaxel Drug Coated Balloon	Device: Lutonix DCB; Other Name: LTX DCB
Active Comparator: PTA Catheter; Standard Uncoated PTA Catheter	Device: Uncoated PTA Catheter; Other Name: PTA

Outcome Measures

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Primary Outcome Measures :

1. Freedom from BTK MALE+POD [ Time Frame: 30 days ]
   Composite of all-cause death, above-ankle amputation or major reintervention
2. Limb Salvage [ Time Frame: 6 months ]
   Freedom from the composite of above ankle amputation
3. Primary Patency [ Time Frame: 6 months ]
   Freedom from target vessel occlusion and clinically driven target lesion reintervention

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Male or non-pregnant female ≥18 years of age;
• Rutherford Clinical Category 3, 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;
• Planned major amputation (of either leg)
• Prior major amputation if amputation occurred less than one year prior to enrollment and if patient is not independently ambulating;
• GFR ≤ 30 ml/min per 1.73m2;
• Acute limb ischemia;
• In-stent restenosis of target lesion

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 53 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	C. R. Bard
ClinicalTrials.gov Identifier:	NCT01870401 History of Changes
Other Study ID Numbers:	CL0005-01
First Posted:	June 6, 2013
Last Update Posted:	February 1, 2018
Last Verified:	January 2018

Additional relevant MeSH terms:

Ischemia; Pathologic Processes