Chronic Kidney DiseaseNCT03715452
DyeVert™ Plus Contrast Reduction System Multicenter Observational Study
An observational study of Chronic Kidney Disease, run by Osprey Medical, Inc at 8 sites in United States.
Trial summary
This is a prospective, single arm, multi-center, observational clinical study of the DyeVert Plus System. The DyeVert Plus System is an FDA-cleared device designed to reduce contrast media volume delivered during angiography and permit real-time contrast media volume monitoring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- DyeVert Plus Contrast Reduction System
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 114 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Jul 2017to 30 Mar 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects undergoing diagnostic coronary angiography (CAG) and/or percutaneous coronary interventional (PCI) procedures performed with manual injections
Who may be able to join
- Scheduled to undergo CAG and/or PCI
- Baseline estimated glomerular filtration rate (eGFR) of ≥20 and ≤60 mL/ min/1.73 m2
Who cannot join
- Acute ST-elevation myocardial infarction or known coronary artery fistulas
- Body mass index (BMI) >40
- Currently pregnant
- Undergoing a chronic total occlusion procedure or optical coherence tomography analysis
- Planning to undergo transcatheter aortic valve replacement within 72 hr of the index procedure
- A condition known to require large volumes of contrast (>10 mL) for each injection
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Atlanta VA Medical Center, Emory University School of Medicine
Atlanta, Georgia, 30308
University of Chicago Medical Center
Chicago, Illinois, 60637
Christ Hospital, Heart and Vascular Center, Lindner Research Center
Cincinnati, Ohio, 45219
WakeMed Heart and Vascular
Raleigh, North Carolina, 27518
William Beaumont Hospital
Royal Oak, Michigan, 48073
Washington University School of Medicine
St Louis, Missouri, 63110
Harbor UCLA Medical Center
Torrance, California, 90509
North Mississippi Medical Center
Tupelo, Mississippi, 38801
About this study
Official title: Minimizing Radiographic Contrast Administration During Coronary Angiography Using a Novel Contrast Reduction System: A Multicenter Observational Study of the DyeVert™ Plus Contrast Reduction System
This is a prospective, single arm, multi-center, observational clinical study of the DyeVert Plus System. The DyeVert Plus System is an FDA-cleared device designed to reduce contrast media volume delivered during angiography and permit real-time contrast media volume monitoring.
Read the detailed description
The purpose of this observational study is to evaluate the amount of contrast media saved using DyeVert Plus in coronary angiographic and/or interventional procedures performed with manual injection and evaluate the impact of predetermined thresholds and real-time monitoring.
- Conditions
- Chronic Kidney Disease
- Being tested
- DyeVert Plus Contrast Reduction System
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DyeVert Plus Contrast Reduction SystemDevice
The DyeVert Plus System interfaces with standard manifold systems to provide real-time contrast monitoring and reduce the amount of contrast used in catheterization procedures while maintaining fluoroscopic image quality. System components include a disposable, single-use, sterile DyeVert Plus Disposable Kit that contains a Smart Syringe and DyeVert Plus Module, which is connected to a standard manifold and provides fluid pathway resistance modulation via a dedicated diversion valve. The diversion valve self-adjusts to the manual injection pressure to divert some of the contrast media into the reservoir chamber within the module. This diverted volume of contrast media does not enter the patient.
| Study group | Role | What they receive |
|---|---|---|
| DyeVert Plus Contrast Reduction System | DyeVert Plus Contrast Reduction System Receives: Device: DyeVert Plus Contrast Reduction System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Contrast Media Volume Saved
The percentage of contrast media volume saved (diverted) over the total procedure as reported on the DyeVert Plus display at the end of each case.
Measured: At the time of the coronary angiography (CAG) or percutaneous coronary interventional (PCI) procedure
Secondary outcomes (1)
Evaluation of Adverse Events Through Discharge (From the Index Procedure)
An adverse event is defined as "any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device." DyeVert Plus System-related adverse events will be collected. Additionally, contrast media-related adverse events, such as acute kidney injury and anaphylactic shock, will be collected.
Measured: From the time of the procedure through discharge (from the index procedure, approximately 0 - 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 Jul 2017
- Primary completion31 Jan 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osprey Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715452
- Sponsor's protocol ID
- TP-6579
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2018
- Last updated
- 19 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimizing Radiographic Contrast Administration During Coronary Angiography Using a Novel Contrast Reduction System: A Multicenter Observational Study of the DyeVert™ Plus Contrast Reduction System
- ClinicalTrials.gov ID
- NCT03715452
- Acronym / sponsor ID
- TP-6579
- Conditions
- Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Osprey Medical, IncIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Posted 19 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single arm, multi-center, observational clinical study of the DyeVert Plus System. The DyeVert Plus System is an FDA-cleared device designed to reduce contrast media volume delivered during angiography and permit real-time contrast media volume monitoring.
Detailed description
The purpose of this observational study is to evaluate the amount of contrast media saved using DyeVert Plus in coronary angiographic and/or interventional procedures performed with manual injection and evaluate the impact of predetermined thresholds and real-time monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DyeVert Plus Contrast Reduction System | – | Device: DyeVert Plus Contrast Reduction SystemDyeVert Plus Contrast Reduction System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects undergoing diagnostic coronary angiography (CAG) and/or percutaneous coronary interventional (PCI) procedures performed with manual injections
Key inclusion criteria (2 listed)
- Scheduled to undergo CAG and/or PCI
- Baseline estimated glomerular filtration rate (eGFR) of ≥20 and ≤60 mL/ min/1.73 m2
Key exclusion criteria (6 listed)
- Acute ST-elevation myocardial infarction or known coronary artery fistulas
- Body mass index (BMI) >40
- Currently pregnant
- Undergoing a chronic total occlusion procedure or optical coherence tomography analysis
- Planning to undergo transcatheter aortic valve replacement within 72 hr of the index procedure
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 |
|---|---|---|
| DyeVert Plus Contrast Reduction SystemThe DyeVert Plus System interfaces with standard manifold systems to provide real-time contrast monitoring and reduce the amount of contrast used in catheterization procedures while maintaining fluoroscopic image quality. System components include a disposable, single-use, sterile DyeVert Plus Disposable Kit that contains a Smart Syringe and DyeVert Plus Module, which is connected to a standard manifold and provides fluid pathway resistance modulation via a dedicated diversion valve. The diversion valve self-adjusts to the manual injection pressure to divert some of the contrast media into the reservoir chamber within the module. This diverted volume of contrast media does not enter the patient. | Device | DyeVert Plus Contrast Reduction System |
Primary outcome
Percentage of Contrast Media Volume Saved
Time frame: At the time of the coronary angiography (CAG) or percutaneous coronary interventional (PCI) procedure
The percentage of contrast media volume saved (diverted) over the total procedure as reported on the DyeVert Plus display at the end of each case.
1 secondary outcome
Evaluation of Adverse Events Through Discharge (From the Index Procedure)
Time frame: From the time of the procedure through discharge (from the index procedure, approximately 0 - 3 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Osprey Medical, Inc at 8 sites in United States.
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 2 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: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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?
Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Contrast Media Volume Saved (time frame: At the time of the coronary angiography (CAG) or percutaneous coronary interventional (PCI) procedure). 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 19 Oct 2020.