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

Spectranetics

Status: Suspended

Conditions: Critical Limb Ischemia

Treatments: Device: PTA Catheter; Device: Stellarex DCB

Study type: Interventional

Funder types: Industry

Identifiers

NCT03175744

D032150

Details and patient eligibility

About

The purpose is to demonstrate the safety and effectiveness of the Stellarex DCB for the treatment of stenosis or occlusions of below-the-knee arteries.

Enrollment: 82 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Rutherford Clinical Category 4-5
• Life expectancy > 1 year
• Significant stenosis ≥70%
• Patent inflow artery
• Target vessel(s) diameter between 2 and 4 mm
• Target vessel(s) reconstitute(s) at the ankle

Exclusion criteria

• Pregnant or planning to become pregnant
• History of stroke within 3 months
• Planned major amputation
• eGFR <30
• Acute limb ischemia
• Prior stent placement in target lesion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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82 participants in 2 patient groups

Stellarex DCB

Experimental group

Description:

Spectranetics Stellarex Drug Coated Balloon

Treatment:

Device: Stellarex DCB

PTA Catheter

Active Comparator group

Description:

Standard Uncoated Balloon Angioplasty Catheter

Treatment:

Device: PTA Catheter