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

C. R. Bard

Status: Completed

Conditions: Critical Limb Ischemia

Treatments: Device: Lutonix DCB; Device: Uncoated PTA Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT01870401

CL0005-01

Details and patient eligibility

About

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.

Enrollment: 442 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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442 participants in 2 patient groups

Lutonix DCB

Experimental group

Description:

Lutonix Paclitaxel Drug Coated Balloon

Treatment:

Device: Lutonix DCB

PTA Catheter

Active Comparator group

Description:

Standard Uncoated PTA Catheter

Treatment:

Device: Uncoated PTA Catheter