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

Spectranetics Corporation82 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Critical Limb Ischemia

Interventions

Stellarex DCBDEVICE

Intervention with the Stellarex DCB

PTA CatheterDEVICE

Intervention with an uncoated Standard PTA

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (21)

St. Joseph Hospital

Orange, California, United States

Bradenton Cardiology Center

Bradenton, Florida, United States

Outcomes

Primary Outcomes

Freedom from Major Adverse Limb Event (MALE)

Composite of major amputation or major reintervention on a per patient basis

Time frame: 30 days

Freedom from Perioperative Death (POD)

Death on a per patient basis

Time frame: 30 days

Patency

Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis

Time frame: 6 months

Limb Salvage

Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis

Time frame: 6 months

Secondary Outcomes

Clinically-driven target lesion revascularization

Rate of clinically-driven target lesion revascularization

Time frame: 6 months

Major adverse event rates

Composite rate of all-cause death, major amputation and clinically driven target lesion reintervention

Time frame: 6 months

Patency rate

Absence of target lesion occlusion and freedom from clinically-driven target lesion reintervention

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.