Coronary AngiographyNCT02606734
DyeVert Pilot Trial
A study testing Coronary Angiography in people with Coronary Angiography, run by Osprey Medical, Inc at 2 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the usability characteristics of DyeVert™ during normal clinical use and to understand the amount of contrast media (CM) diverted from the subject and saved over a total angiographic procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Angiography
- What is being tested?
- Coronary Angiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2015to Dec 2015
- Phase
- Interventional
- 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
Who may be able to join
- The subject is indicated for a coronary angiogram or percutaneous coronary procedure
- The subject is ≥ 18 years of age
- The subject (or subject's legal representative) is willing and able to provide appropriate informed consent.
Who cannot join
- Subject is undergoing a STEMI procedure
- The subject is female and currently pregnant
- In the investigator's opinion, the subject is not considered to be a suitable candidate
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The purpose of this study is to evaluate the usability characteristics of DyeVert™ during normal clinical use and to understand the amount of contrast media (CM) diverted from the subject and saved over a total angiographic procedure.
- Conditions
- Coronary Angiography
- Being tested
- Coronary Angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary AngiographyDevice
The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Other | All subjects enrolled in the trial will use the DyeVert System. Receives: Device: Coronary Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume (Percentage) of Contrast Media (CM) Diverted (Saved) in a Total Procedure
The subject is exited from the study once they are discharged.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionDec 2015
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 Coronary AngiographyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 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
- NCT02606734
- Sponsor's protocol ID
- TP-6463
- Status last verified
- Sep 2016
- First submitted
- 28 Oct 2015
- Last updated
- 26 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DyeVert Pilot Trial
- ClinicalTrials.gov ID
- NCT02606734
- Acronym / sponsor ID
- TP-6463
- Conditions
- Coronary Angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Osprey Medical, IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Nov 2015 (estimated)
- Results
- Posted 8 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the usability characteristics of DyeVert™ during normal clinical use and to understand the amount of contrast media (CM) diverted from the subject and saved over a total angiographic procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Other | Device: Coronary AngiographyAll subjects enrolled in the trial will use the DyeVert System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subject is indicated for a coronary angiogram or percutaneous coronary procedure
- The subject is ≥ 18 years of age
- The subject (or subject's legal representative) is willing and able to provide appropriate informed consent.
Key exclusion criteria (3 listed)
- Subject is undergoing a STEMI procedure
- The subject is female and currently pregnant
- In the investigator's opinion, the subject is not considered to be a suitable candidate
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 |
|---|---|---|
| Coronary AngiographyThe DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases. | Device | Treatment Arm |
Primary outcome
Volume (Percentage) of Contrast Media (CM) Diverted (Saved) in a Total Procedure
Time frame: 1 Day
The subject is exited from the study once they are discharged.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Angiography in people with Coronary Angiography, run by Osprey Medical, Inc at 2 sites in 2 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 3 inclusion and 3 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 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Germany. 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 8 Aug 2016). 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?
Volume (Percentage) of Contrast Media (CM) Diverted (Saved) in a Total Procedure (time frame: 1 Day). 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 26 Oct 2016.