Coronary Artery DiseaseDCR4ContrastNCT04085614
Dynamic Coronary Roadmap for Contrast Reduction
A study testing Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap and Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap in people with Coronary Artery Disease, run by Philips Clinical & Medical Affairs Global at 6 sites in 4 countries.
Trial summary
The Dynamic Coronary Roadmap is a commercially available product developed by Philips Medical Systems, a Philips Healthcare company. Dynamic Coronary Roadmap is a software medical device intended to provide a real-time and dynamic angiographic roadmap of coronary arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap and Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 371 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 1 Oct 2019to 9 Feb 2023
- 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
- Subject is undergoing Percutaneous Coronary Intervention (PCI) with a degree of complexity that anticipates the need for more than 25ml of iodinated contrast volume
- Subject has signed informed consent
- Subject is 18 years of age or older, or of legal age to give informed consent per state or national law
Who cannot join
- Subject undergoing emergency Percutaneous Coronary Intervention (PCI)
- Subject with ST-segment Elevation Myocardial Infarction (STEMI)
- Subject with Chronic Total Occlusion (CTO)
- Subject undergoing PCI for isolated ostial disease of Left Main Coronary Artery (LMCA) or Right Coronary Artery (RCA)
- Subject undergoing Percutaneous Coronary Intervention (PCI) with Optical Coherence Tomography (OCT) support
- Subject undergoing Percutaneous Coronary Intervention (PCI) with rotational or orbital atherectomy
Show all 10Show fewer
- Subject with Chronic Kidney Disease (CKD) stage V (estimated Glomerular Filtration Rate (eGFR) < 15 ml/min/1.73 m^2)
- Subject with contrast allergy that cannot be adequately pre-medicated
- Subject participates in a potentially confounding drug or device trial during the course of the study.
- Subject is under 18 years of age, or pregnant woman, or breast feeding woman, or meets an exclusion criteria according to national law
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
United States2 sites
University of Colorado Hospital
Denver, Colorado, 80045
Columbia University Medical Center/NYPH
New York, New York, 10032
Spain2 sites
San Carlos Hospital
Madrid, 28040
Fuenlabrada University Hospital
Madrid
About this study
The Dynamic Coronary Roadmap is a commercially available product developed by Philips Medical Systems, a Philips Healthcare company. Dynamic Coronary Roadmap is a software medical device intended to provide a real-time and dynamic angiographic roadmap of coronary arteries. The angiographic roadmap is automatically generated from previously acquired coronary angiograms during the same procedure. Dynamic Coronary Roadmap overlays the angiographic roadmap on live 2D fluoroscopic images, thereby assisting the physician in navigating devices, e.g. (guide) wires, catheters, through the coronary arteries.
This is a multi-center, prospective, unblinded, stratified 1:1 randomized controlled trial to assess whether using Dynamic Coronary Roadmap reduces the total iodinated contrast volume related to Percutaneous Coronary Intervention (PCI) compared to the control group without Dynamic Coronary Roadmap.
Read the detailed description
Primary objective:
- To assess whether using Dynamic Coronary Roadmap reduces the total iodinated contrast volume related to Percutaneous Coronary Intervention (PCI) compared to the control group without Dynamic Coronary Roadmap.
Secondary objective:
- To assess the total number of contrast enhanced cine angiographic X-ray runs (angiograms) related to Percutaneous Coronary Intervention (PCI) in the Dynamic Coronary Roadmap and control group
- Conditions
- Coronary Artery Disease
- Being tested
- Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap, Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap
- 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.
Percutaneous Coronary Intervention (PCI) with Dynamic Coronary RoadmapDevice
Standard of care Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap
Percutaneous Coronary Intervention (PCI) without Dynamic Coronary RoadmapDevice
Standard of care Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap
| Study group | Role | What they receive |
|---|---|---|
| Dynamic Coronary Roadmap group | Experimental | Patients will be treated via standard of care for Percutaneous Coronary Intervention (PCI) with navigation support of Dynamic Coronary Roadmap. Receives: Device: Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap |
| Control group | Active comparator | Patients will be treated via standard of care for Percutaneous Coronary Intervention (PCI) without navigation support of Dynamic Coronary Roadmap. Receives: Device: Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Percutaneous Coronary Intervention (PCI) Iodinated Contrast Volume
Average total undiluted contrast volume (in ml, measured by an automatic contrast injector) per Percutaneous Coronary Intervention (PCI), where the start of the PCI is marked by the moment the interventional guiding catheter is positioned in a stable coronary position and the end of the PCI is marked by time of the last PCI check exposure run (angiogram).
Measured: During Percutaneous Coronary Intervention (PCI) procedure
Secondary outcomes (1)
Number of Angiograms
Average total number of contrast enhanced cine angiographic X-ray runs (angiograms) per Percutaneous Coronary Intervention (PCI) (from start of PCI marked by the moment the interventional guiding catheter is positioned in a stable coronary position till the end of the PCI marked by the time of the last PCI check exposure run, i.e., angiogram) determined via visual assessment (e.g., on the Philips X-ray system).
Measured: During Percutaneous Coronary Intervention (PCI) procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start1 Oct 2019
- Primary completion9 Feb 2023
- Study completion9 Feb 2023
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Javier Escaned, MD, Principal investigator, San Carlos Hospital Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085614
- Sponsor's protocol ID
- XCY612-130576
- Acronym
- DCR4Contrast
- Status last verified
- Jan 2024
- First submitted
- 9 Sep 2019
- Last updated
- 8 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hennessey B, Danenberg H, De Vroey F, Kirtane AJ, Parikh M, Karmpaliotis D, Messenger JC, Strobel A, Curcio A, van Mourik MS, Eshuis P, Escaned J. Dynamic Coronary Roadmap versus standard angiography for percutaneous coronary intervention: the randomised, multicentre DCR4Contrast trial. EuroIntervention. 2024 Feb 5;20(3):e198-e206. doi: 10.4244/EIJ-D-23-00460.
PubMed 38343370Hennessey B, Messenger JC, Kirtane AJ, Parikh M, Danenberg H, De Vroey F, Curcio A, Eshuis P, Escaned J. Rationale and design of the Dynamic Coronary Roadmap for Contrast Reduction (DCR4Contrast) in PCI randomized controlled trial. Am Heart J. 2023 Sep;263:151-158. doi: 10.1016/j.ahj.2023.04.004. Epub 2023 Apr 9.
PubMed 37040861
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Coronary Roadmap for Contrast Reduction
- ClinicalTrials.gov ID
- NCT04085614
- Acronym / sponsor ID
- DCR4Contrast / XCY612-130576
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 9 Feb 2023 (actual)
- First posted
- 11 Sep 2019 (actual)
- Results
- Posted 8 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Dynamic Coronary Roadmap is a commercially available product developed by Philips Medical Systems, a Philips Healthcare company. Dynamic Coronary Roadmap is a software medical device intended to provide a real-time and dynamic angiographic roadmap of coronary arteries. The angiographic roadmap is automatically generated from previously acquired coronary angiograms during the same procedure. Dynamic Coronary Roadmap overlays the angiographic roadmap on live 2D fluoroscopic images, thereby assisting the physician in navigating devices, e.g. (guide) wires, catheters, through the coronary arteries.
This is a multi-center, prospective, unblinded, stratified 1:1 randomized controlled trial to assess whether using Dynamic Coronary Roadmap reduces the total iodinated contrast volume related to Percutaneous Coronary Intervention (PCI) compared to the control group without Dynamic Coronary Roadmap.
Detailed description
Primary objective:
- To assess whether using Dynamic Coronary Roadmap reduces the total iodinated contrast volume related to Percutaneous Coronary Intervention (PCI) compared to the control group without Dynamic Coronary Roadmap.
Secondary objective:
- To assess the total number of contrast enhanced cine angiographic X-ray runs (angiograms) related to Percutaneous Coronary Intervention (PCI) in the Dynamic Coronary Roadmap and control group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic Coronary Roadmap group | Experimental | Device: Percutaneous Coronary Intervention (PCI) with Dynamic Coronary RoadmapPatients will be treated via standard of care for Percutaneous Coronary Intervention (PCI) with navigation support of Dynamic Coronary Roadmap. |
| Control group | Active comparator | Device: Percutaneous Coronary Intervention (PCI) without Dynamic Coronary RoadmapPatients will be treated via standard of care for Percutaneous Coronary Intervention (PCI) without navigation support of Dynamic Coronary Roadmap. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is undergoing Percutaneous Coronary Intervention (PCI) with a degree of complexity that anticipates the need for more than 25ml of iodinated contrast volume
- Subject has signed informed consent
- Subject is 18 years of age or older, or of legal age to give informed consent per state or national law
Key exclusion criteria (10 listed)
- Subject undergoing emergency Percutaneous Coronary Intervention (PCI)
- Subject with ST-segment Elevation Myocardial Infarction (STEMI)
- Subject with Chronic Total Occlusion (CTO)
- Subject undergoing PCI for isolated ostial disease of Left Main Coronary Artery (LMCA) or Right Coronary Artery (RCA)
- Subject undergoing Percutaneous Coronary Intervention (PCI) with Optical Coherence Tomography (OCT) support
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 |
|---|---|---|
| Percutaneous Coronary Intervention (PCI) with Dynamic Coronary RoadmapStandard of care Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap | Device | Dynamic Coronary Roadmap group |
| Percutaneous Coronary Intervention (PCI) without Dynamic Coronary RoadmapStandard of care Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap | Device | Control group |
Primary outcome
Total Percutaneous Coronary Intervention (PCI) Iodinated Contrast Volume
Time frame: During Percutaneous Coronary Intervention (PCI) procedure
Average total undiluted contrast volume (in ml, measured by an automatic contrast injector) per Percutaneous Coronary Intervention (PCI), where the start of the PCI is marked by the moment the interventional guiding catheter is positioned in a stable coronary position and the end of the PCI is marked by time of the last PCI check exposure run (angiogram).
1 secondary outcome
Number of Angiograms
Time frame: During Percutaneous Coronary Intervention (PCI) procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38343370Hennessey B, Danenberg H, De Vroey F, Kirtane AJ, Parikh M, Karmpaliotis D, Messenger JC, Strobel A, Curcio A, van Mourik MS, Eshuis P, Escaned J. Dynamic Coronary Roadmap versus standard angiography for percutaneous coronary intervention: the randomised, multicentre DCR4Contrast trial. EuroIntervention. 2024 Feb 5;20(3):e198-e206. doi: 10.4244/EIJ-D-23-00460.
- Derived from this study: PubMed 37040861Hennessey B, Messenger JC, Kirtane AJ, Parikh M, Danenberg H, De Vroey F, Curcio A, Eshuis P, Escaned J. Rationale and design of the Dynamic Coronary Roadmap for Contrast Reduction (DCR4Contrast) in PCI randomized controlled trial. Am Heart J. 2023 Sep;263:151-158. doi: 10.1016/j.ahj.2023.04.004. Epub 2023 Apr 9.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruiting
GOT VOICE Feasibility With In-Person Group Singing
Elderly, Coronary Arterial Disease (CAD)
RecruitingObservational study
Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry
Cardiovascular Diseases
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
Coronary Artery Disease, Coronary Artery Stenoses
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.
Javier Escaned, MD principal investigator
San Carlos Hospital Madrid
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap and Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap in people with Coronary Artery Disease, run by Philips Clinical & Medical Affairs Global at 6 sites in 4 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 10 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 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Spain, Belgium, Israel. 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 Jan 2024). 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?
Total Percutaneous Coronary Intervention (PCI) Iodinated Contrast Volume (time frame: During Percutaneous Coronary Intervention (PCI) procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04085614, which also lists 2 linked publications.
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 8 Jan 2024.