NCT04085614

Brief 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. 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
371

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
4 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2023

Completed
11 months until next milestone

Results Posted

Study results publicly available

January 8, 2024

Completed
Last Updated

January 8, 2024

Status Verified

January 1, 2024

Enrollment Period

3.4 years

First QC Date

September 9, 2019

Results QC Date

November 21, 2023

Last Update Submit

January 5, 2024

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • 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).

    During Percutaneous Coronary Intervention (PCI) procedure

Secondary Outcomes (1)

  • Number of Angiograms

    During Percutaneous Coronary Intervention (PCI) procedure

Study Arms (2)

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.

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.

Device: Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap

Interventions

Percutaneous Coronary Intervention (PCI) with Dynamic Coronary RoadmapDEVICE

Standard of care Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap

Dynamic Coronary Roadmap group
Percutaneous Coronary Intervention (PCI) without Dynamic Coronary RoadmapDEVICE

Standard of care Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Colorado Hospital

Denver, Colorado, 80045, United States

Location

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

Location

Grand Hôpital de Charleroi Saint-Joseph

Charleroi, 6060, Belgium

Location

Hadassah Medical Center

Jerusalem, Israel

Location

San Carlos Hospital

Madrid, 28040, Spain

Location

Fuenlabrada University Hospital

Madrid, Spain

Location

Related Publications (2)

  • 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.

    PMID: 38343370DERIVED

  • Hennessey 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.

    PMID: 37040861DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Results Point of Contact

Title
Peter Eshuis
Organization
Philips Medical Systems Nederland B.V.
peter.g.eshuis@philips.com
+31628739280

Study Officials

  • Javier Escaned, MD

    San Carlos Hospital Madrid

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2019

First Posted

September 11, 2019

Study Start

October 1, 2019

Primary Completion

February 9, 2023

Study Completion

February 9, 2023

Last Updated

January 8, 2024

Results First Posted

January 8, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)BE(1)US(2)ES(2)