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

Primary Purpose

Critical Limb Ischemia

Status
Suspended
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Stellarex DCB
PTA Catheter
Sponsored by
Spectranetics Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Limb Ischemia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • St. Joseph Hospital
  • Bradenton Cardiology Center
  • Cardiovascular Institute of the South
  • Hackensack University Medical Center
  • Icahn School of Medicine at Mount Sinai
  • University Hospitals, Cleveland Medical Center
  • Bryn Mawr Hospital
  • Pinnacle Health Cardiovascular Institute
  • Greenville Health System
  • Flinders Medical Center
  • Sir Charles Gairdner Hospital
  • LKH Universitatsklinik Graz
  • Medizinische Universitat Wien
  • Imelda Ziekenhuis
  • ZOL St. jan
  • University Hospital Gent
  • Klinikum Hoschsauerland GmbH
  • Universitats-Herzzentrum Freiburg-Bad Krozingen
  • SRH Klinikum Karlsbad
  • Universitatsklink Leipzig
  • University Hospital of Tuebingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stellarex DCB

PTA Catheter

Arm Description

Spectranetics Stellarex Drug Coated Balloon

Standard Uncoated Balloon Angioplasty Catheter

Outcomes

Primary Outcome Measures

Freedom from Major Adverse Limb Event (MALE)
Composite of major amputation or major reintervention on a per patient basis
Freedom from Perioperative Death (POD)
Death on a per patient basis
Patency
Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis
Limb Salvage
Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis

Secondary Outcome Measures

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

Full Information

First Posted
March 10, 2017
Last Updated
June 21, 2023
Sponsor
Spectranetics Corporation
Collaborators
Philips Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT03175744
Brief Title
Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
Acronym
ILLUMENATE-BTK
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Suspended
Why Stopped
Patient enrollment impacted by COVID-19 pandemic and other business challenges. Patient enrollment discontinued, but follow-ups will continue according to protocol.
Study Start Date
May 24, 2017 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectranetics Corporation
Collaborators
Philips Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stellarex DCB
Arm Type
Experimental
Arm Description
Spectranetics Stellarex Drug Coated Balloon
Arm Title
PTA Catheter
Arm Type
Active Comparator
Arm Description
Standard Uncoated Balloon Angioplasty Catheter
Intervention Type
Device
Intervention Name(s)
Stellarex DCB
Intervention Description
Intervention with the Stellarex DCB
Intervention Type
Device
Intervention Name(s)
PTA Catheter
Intervention Description
Intervention with an uncoated Standard PTA
Primary Outcome Measure Information:
Title
Freedom from Major Adverse Limb Event (MALE)
Description
Composite of major amputation or major reintervention on a per patient basis
Time Frame
30 days
Title
Freedom from Perioperative Death (POD)
Description
Death on a per patient basis
Time Frame
30 days
Title
Patency
Description
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
Title
Limb Salvage
Description
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 Outcome Measure Information:
Title
Clinically-driven target lesion revascularization
Description
Rate of clinically-driven target lesion revascularization
Time Frame
6 months
Title
Major adverse event rates
Description
Composite rate of all-cause death, major amputation and clinically driven target lesion reintervention
Time Frame
6 months
Title
Patency rate
Description
Absence of target lesion occlusion and freedom from clinically-driven target lesion reintervention
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Gray, MD
Organizational Affiliation
Lankenau Heart Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mahmood K Razavi, MD
Organizational Affiliation
Vascular and Interventional Specialists of Orange
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dierk Scheinert, MD
Organizational Affiliation
University of Leipzig
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph Hospital
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Bradenton Cardiology Center
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Cardiovascular Institute of the South
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University Hospitals, Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Bryn Mawr Hospital
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Pinnacle Health Cardiovascular Institute
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Flinders Medical Center
City
Bedford Park
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Perth
Country
Australia
Facility Name
LKH Universitatsklinik Graz
City
Graz
Country
Austria
Facility Name
Medizinische Universitat Wien
City
Vienna
Country
Austria
Facility Name
Imelda Ziekenhuis
City
Bonheiden
Country
Belgium
Facility Name
ZOL St. jan
City
Genk
Country
Belgium
Facility Name
University Hospital Gent
City
Gent
Country
Belgium
Facility Name
Klinikum Hoschsauerland GmbH
City
Arnsberg
Country
Germany
Facility Name
Universitats-Herzzentrum Freiburg-Bad Krozingen
City
Bad Krozingen
Country
Germany
Facility Name
SRH Klinikum Karlsbad
City
Karlsbad
ZIP/Postal Code
76307
Country
Germany
Facility Name
Universitatsklink Leipzig
City
Leipzig
Country
Germany
Facility Name
University Hospital of Tuebingen
City
Tuebingen
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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