Critical Limb IschemiaILLUMENATE-BTKNCT03175744
Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
A study testing Stellarex DCB and PTA Catheter in people with Critical Limb Ischemia, run by Spectranetics Corporation at 21 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- Stellarex DCB and PTA Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 21 sitesin 5 countries
- Study dates
- 24 May 2017to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
21 sites in 5 countries.
21 sites in 5 countries
United States9 sites
Bradenton Cardiology Center
Bradenton, Florida, 34205
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
University Hospitals, Cleveland Medical Center
Cleveland, Ohio, 44106
Greenville Health System
Greenville, South Carolina, 29615
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Cardiovascular Institute of the South
Houma, Louisiana, 70360
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
St. Joseph Hospital
Orange, California, 92868
Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania, 17043
Germany5 sites
Klinikum Hoschsauerland GmbH
Arnsberg
Universitats-Herzzentrum Freiburg-Bad Krozingen
Bad Krozingen
SRH Klinikum Karlsbad
Karlsbad, 76307
Universitatsklink Leipzig
Leipzig
University Hospital of Tuebingen
Tübingen
Belgium3 sites
Imelda Ziekenhuis
Bonheiden
ZOL St. jan
Genk
University Hospital Gent
Ghent
Australia2 sites
Flinders Medical Center
Bedford Park
Sir Charles Gairdner Hospital
Perth
Austria2 sites
LKH Universitatsklinik Graz
Graz
Medizinische Universitat Wien
Vienna
About this study
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
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.
- Conditions
- Critical Limb Ischemia
- Being tested
- Stellarex DCB, PTA Catheter
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellarex DCBDevice
Intervention with the Stellarex DCB
PTA CatheterDevice
Intervention with an uncoated Standard PTA
| Study group | Role | What they receive |
|---|---|---|
| Stellarex DCB | Experimental | Spectranetics Stellarex Drug Coated Balloon Receives: Device: Stellarex DCB |
| PTA Catheter | Active comparator | Standard Uncoated Balloon Angioplasty Catheter Receives: Device: PTA Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Major Adverse Limb Event (MALE)
Composite of major amputation or major reintervention on a per patient basis
Measured: 30 days
Freedom from Perioperative Death (POD)
Death on a per patient basis
Measured: 30 days
Patency
Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis
Measured: 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
Measured: 6 months
Secondary outcomes (3)
Clinically-driven target lesion revascularization
Rate of clinically-driven target lesion revascularization
Measured: 6 months
Major adverse event rates
Composite rate of all-cause death, major amputation and clinically driven target lesion reintervention
Measured: 6 months
Patency rate
Absence of target lesion occlusion and freedom from clinically-driven target lesion reintervention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start24 May 2017
- Primary completion30 Apr 2022
- Study completionOct 2025 (estimated)
Why it stopped: Patient enrollment impacted by COVID-19 pandemic and other business challenges. Patient enrollment discontinued, but follow-ups will continue according to protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectranetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Philips Healthcare
- Responsible party
- Sponsor
- Investigators
- William Gray, MD, Principal investigator, Lankenau Heart InstituteMahmood K Razavi, MD, Principal investigator, Vascular and Interventional Specialists of OrangeDierk Scheinert, MD, Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175744
- Sponsor's protocol ID
- D032150
- Acronym
- ILLUMENATE-BTK
- Status last verified
- Jun 2023
- First submitted
- 10 Mar 2017
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03175744
- Acronym / sponsor ID
- ILLUMENATE-BTK / D032150
- Conditions
- Critical Limb Ischemia
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Patient enrollment impacted by COVID-19 pandemic and other business challenges. Patient enrollment discontinued, but follow-ups will continue according to protocol.
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Spectranetics CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Philips Healthcare
- Study start
- 24 May 2017 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- Oct 2025 (estimated)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stellarex DCB | Experimental | Device: Stellarex DCBSpectranetics Stellarex Drug Coated Balloon |
| PTA Catheter | Active comparator | Device: PTA CatheterStandard Uncoated Balloon Angioplasty Catheter |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Rutherford Clinical Category 4-5
- Life expectancy > 1 year
- Significant stenosis ≥70%
- Patent inflow artery
- Target vessel(s) diameter between 2 and 4 mm
Key exclusion criteria (6 listed)
- Pregnant or planning to become pregnant
- History of stroke within 3 months
- Planned major amputation
- eGFR <30
- Acute limb ischemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stellarex DCBIntervention with the Stellarex DCB | Device | Stellarex DCB |
| PTA CatheterIntervention with an uncoated Standard PTA | Device | PTA Catheter |
Primary outcome
Freedom from Major Adverse Limb Event (MALE)
Time frame: 30 days
Composite of major amputation or major reintervention on a per patient basis
Freedom from Perioperative Death (POD)
Time frame: 30 days
Death on a per patient basis
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
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
3 secondary outcomes
Clinically-driven target lesion revascularization
Time frame: 6 months
Major adverse event rates
Time frame: 6 months
Patency rate
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Gray, MD principal investigator
Lankenau Heart Institute
Mahmood K Razavi, MD principal investigator
Vascular and Interventional Specialists of Orange
Dierk Scheinert, MD principal investigator
University of Leipzig
21 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stellarex DCB and PTA Catheter in people with Critical Limb Ischemia, run by Spectranetics Corporation at 21 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Germany, Belgium, Australia, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from Major Adverse Limb Event (MALE) (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.