Chronic Total Occlusion of Coronary ArteryREDUCeNCT03118544
REduction of Contrast Via DyeVert Used in CTO Procedures
An observational study of Chronic Total Occlusion of Coronary Artery, run by Minneapolis Heart Institute Foundation at 3 sites in United States.
Trial summary
The is an observational, prospective study to evaluate the effect of the DyeVert System on contrast volume administration in patients undergoing clinically-indicated chronic total occlusion (CTO) percutaneous coronary intervention (PCI) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Total Occlusion of Coronary Artery
- What is being tested?
- DyeVert System
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Mar 2017to 2 Feb 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing clinically-indicated chronic total occlusion (CTO) percutaneous coronary intervention (PCI)
Who may be able to join
- Subjects undergoing CTO PCI at each of the participating centers.
- Contrast volume recorded during CTO PCI
- Subjects included in the "Multicenter Registry of Chronic Total Occlusion Interventions" study (Allina IRB approval # 948134-1)
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
About this study
Official title: REduction of Contrast Via DyeVert Used in CTO Procedures (REDUCe)
The is an observational, prospective study to evaluate the effect of the DyeVert System on contrast volume administration in patients undergoing clinically-indicated chronic total occlusion (CTO) percutaneous coronary intervention (PCI)
Read the detailed description
The DyeVert System is a disposable, FDA-approved device that interfaces with standard manifold systems to reduce the amount of contrast used in catheterization procedures, while maintaining fluoroscopic image opacity.
No study has assessed use of the system in CTO PCI. It would be expected that savings in CTO procedures may be less than non-CTO procedures due to catheter sizing and number of open guide injections required. Open guide injections through larger catheters do not provide for the as much resistance, therefore decreasing the need for contrast to be diverted
- Being tested
- DyeVert System
- Keywords
- Chronic Total Occlusion, Coronary Artery Disease, Percutaneous Coronary Intervention, CTO, PCI
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DyeVert SystemDevice
The DyeVert System (Osprey Medical, Inc) consists of a Contrast Monitoring Wireless Display (CMW) and the DyeVert Plus Disposable Kit which is inclusive of a disposable single-use sterile Smart Syringe and DyeVert Plus Module.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing CTO PCI | Evaluates the effect of the DyeVert System on contrast volume administration in patients undergoing clinically-indicated CTO PCI. The system allows monitoring and display of contrast volumes that are manually injected during the procedure which will be compared to physician entered contrast usage thresholds during angiographic procedures. Receives: Device: DyeVert System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast volume administration during CTO PCI
The hypothesis of the study is that use of the DyeVert System will result in lower contrast volume, determined through real-time monitoring with the DyeVert System.
Measured: During the CTO PCI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start26 Mar 2017
- Primary completion2 Feb 2018
- Study completion2 Feb 2018
Why it stopped: Competing clinical trial priorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total Occlusion of Coronary ArteryStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Minneapolis Heart Institute Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Osprey Medical, Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118544
- Sponsor's protocol ID
- MinneapolisHIF
- Acronym
- REDUCe
- Status last verified
- May 2018
- First submitted
- 13 Apr 2017
- Last updated
- 17 May 2018
- Results posted
- No
- 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 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REduction of Contrast Via DyeVert Used in CTO Procedures (REDUCe)
- ClinicalTrials.gov ID
- NCT03118544
- Acronym / sponsor ID
- REDUCe / MinneapolisHIF
- Keywords
- Chronic Total Occlusion, Coronary Artery Disease, Percutaneous Coronary Intervention, CTO, PCI
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Competing clinical trial priorities
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Minneapolis Heart Institute FoundationUniversity, hospital or other
- Collaborators
- Osprey Medical, Inc
- Study start
- 26 Mar 2017 (actual)
- Primary completion
- 2 Feb 2018 (actual)
- Study completion
- 2 Feb 2018 (actual)
- First posted
- 18 Apr 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 is an observational, prospective study to evaluate the effect of the DyeVert System on contrast volume administration in patients undergoing clinically-indicated chronic total occlusion (CTO) percutaneous coronary intervention (PCI)
Detailed description
The DyeVert System is a disposable, FDA-approved device that interfaces with standard manifold systems to reduce the amount of contrast used in catheterization procedures, while maintaining fluoroscopic image opacity.
No study has assessed use of the system in CTO PCI. It would be expected that savings in CTO procedures may be less than non-CTO procedures due to catheter sizing and number of open guide injections required. Open guide injections through larger catheters do not provide for the as much resistance, therefore decreasing the need for contrast to be diverted
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing CTO PCI | – | Device: DyeVert SystemEvaluates the effect of the DyeVert System on contrast volume administration in patients undergoing clinically-indicated CTO PCI. The system allows monitoring and display of contrast volumes that are manually injected during the procedure which will be compared to physician entered contrast usage thresholds during angiographic procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing clinically-indicated chronic total occlusion (CTO) percutaneous coronary intervention (PCI)
Key inclusion criteria (3 listed)
- Subjects undergoing CTO PCI at each of the participating centers.
- Contrast volume recorded during CTO PCI
- Subjects included in the "Multicenter Registry of Chronic Total Occlusion Interventions" study (Allina IRB approval # 948134-1)
Key exclusion criteria (1 listed)
- None
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 SystemThe DyeVert System (Osprey Medical, Inc) consists of a Contrast Monitoring Wireless Display (CMW) and the DyeVert Plus Disposable Kit which is inclusive of a disposable single-use sterile Smart Syringe and DyeVert Plus Module. | Device | Patients undergoing CTO PCI |
Primary outcome
Contrast volume administration during CTO PCI
Time frame: During the CTO PCI procedure
The hypothesis of the study is that use of the DyeVert System will result in lower contrast volume, determined through real-time monitoring with the DyeVert System.
Results and safety
The study was stopped early (reason given: Competing clinical trial priorities). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- 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.
3 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 Total Occlusion of Coronary Artery, run by Minneapolis Heart Institute Foundation at 3 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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study was stopped early (reason given: Competing clinical trial priorities). 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?
Contrast volume administration during CTO PCI (time frame: During the CTO 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 17 May 2018.