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

Prospective, Randomized, Multi-Center Study to Evaluate Treatment of Subjects With Occlusive Disease With a Novel Paclitaxel-Coated Angioplasty Balloon in Below-The-Knee (BTK) Arteries

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 Overview

• Status: Suspended
• Conditions: Critical Limb Ischemia
• Intervention / Treatment: Device: Stellarex DCB; Device: PTA Catheter

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Bedford Park, Australia
    • Flinders Medical Center
  • Perth, Australia
    • Sir Charles Gairdner Hospital
• Austria
  • Graz, Austria
    • LKH Universitatsklinik Graz
  • Vienna, Austria
    • Medizinische Universität Wien
• Belgium
  • Bonheiden, Belgium
    • Imelda Ziekenhuis
  • Genk, Belgium
    • ZOL St. jan
  • Gent, Belgium
    • University Hospital Gent
• Germany
  • Arnsberg, Germany
    • Klinikum Hoschsauerland GmbH
  • Bad Krozingen, Germany
    • Universitäts-Herzzentrum Freiburg-Bad Krozingen
  • Karlsbad, Germany, 76307
    • SRH Klinikum Karlsbad
  • Leipzig, Germany
    • Universitatsklink Leipzig
  • Tuebingen, Germany
    • University Hospital of Tuebingen
• United States
  • California
    • Orange, California, United States, 92868
      • St. Joseph Hospital
  • Florida
    • Bradenton, Florida, United States, 34205
      • Bradenton Cardiology Center
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Cardiovascular Institute of the South
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals, Cleveland Medical Center
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Bryn Mawr Hospital
    • Wormleysburg, Pennsylvania, United States, 17043
      • Pinnacle Health Cardiovascular Institute
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Greenville Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PTA Catheter; Standard Uncoated Balloon Angioplasty Catheter	Device: PTA Catheter; Intervention with an uncoated Standard PTA
Experimental: Stellarex DCB; Spectranetics Stellarex Drug Coated Balloon	Device: Stellarex DCB; Intervention with the Stellarex DCB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from Major Adverse Limb Event (MALE)	Composite of major amputation or major reintervention on a per patient basis	30 days
Freedom from Perioperative Death (POD)	Death on a per patient basis	30 days
Patency	Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis	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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically-driven target lesion revascularization	Rate of clinically-driven target lesion revascularization	6 months
Major adverse event rates	Composite rate of all-cause death, major amputation and clinically driven target lesion reintervention	6 months
Patency rate	Absence of target lesion occlusion and freedom from clinically-driven target lesion reintervention	6 months

Collaborators and Investigators

• Sponsor: Spectranetics Corporation
• Collaborators: Philips Healthcare
• Investigators: Principal Investigator: William Gray, MD, Lankenau Heart Institute; Principal Investigator: Mahmood K Razavi, MD, Vascular and Interventional Specialists of Orange; Principal Investigator: Dierk Scheinert, MD, University of Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2017
• Primary Completion (Actual): April 30, 2022
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: June 1, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease Attributes; Atherosclerosis; Peripheral Vascular Diseases; Chronic Disease; Peripheral Arterial Disease; Ischemia; Chronic Limb-Threatening Ischemia
• Other Study ID Numbers: D032150

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes