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

June 21, 2023 updated by: Spectranetics Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Freedom from Major Adverse Limb Event (MALE)
Time Frame: 30 days
Composite of major amputation or major reintervention on a per patient basis
30 days
Freedom from Perioperative Death (POD)
Time Frame: 30 days
Death on a per patient basis
30 days
Patency
Time Frame: 6 months
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
Time Frame: 6 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinically-driven target lesion revascularization
Time Frame: 6 months
Rate of clinically-driven target lesion revascularization
6 months
Major adverse event rates
Time Frame: 6 months
Composite rate of all-cause death, major amputation and clinically driven target lesion reintervention
6 months
Patency rate
Time Frame: 6 months
Absence of target lesion occlusion and freedom from clinically-driven target lesion reintervention
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Spectranetics Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Philips Healthcare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 24, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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