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Dynamic Coronary Roadmap for Contrast Reduction (DCR4Contrast)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PCI with Dynamic Coronary Roadmap
PCI without Dynamic Coronary Roadmap
Sponsored by
Philips Clinical & Medical Affairs Global
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Subject undergoing emergency 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 PCI with Optical Coherence Tomography (OCT) support
  • Subject undergoing PCI with rotational or orbital atherectomy
  • Subject with Chronic Kidney Disease (CKD) stage V (eGFR < 15 ml/min/1.73 m2)
  • 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

Sites / Locations

  • University of Colorado Hospital
  • Columbia University Medical Center/NYPH
  • Grand Hôpital de Charleroi Saint-Joseph
  • Hadassah Medical Center
  • San Carlos Hospital
  • Fuenlabrada University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dynamic Coronary Roadmap group

Control group

Arm Description

Patients will be treated via standard of care for PCI with navigation support of Dynamic Coronary Roadmap.

Patients will be treated via standard of care for PCI without navigation support of Dynamic Coronary Roadmap.

Outcomes

Primary Outcome Measures

Total PCI iodinated contrast volume
Average total undiluted iodinated contrast volume (in ml) used per PCI (from first positioning the interventional guiding catheter in stable coronary position till end of PCI procedure) measured by an automatic contrast injector.

Secondary Outcome Measures

Number of angiograms
Average total number of contrast enhanced cine angiographic X-ray runs (angiograms) per PCI (from first positioning the interventional guiding catheter in stable coronary position till end of PCI procedure) determined via visual assessment (e.g., on the Philips X-ray system)

Full Information

First Posted
September 9, 2019
Last Updated
March 6, 2023
Sponsor
Philips Clinical & Medical Affairs Global
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1. Study Identification

Unique Protocol Identification Number
NCT04085614
Brief Title
Dynamic Coronary Roadmap for Contrast Reduction
Acronym
DCR4Contrast
Official Title
Dynamic Coronary Roadmap for Contrast Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
February 9, 2023 (Actual)
Study Completion Date
February 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Clinical & Medical Affairs Global

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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 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 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 PCI in the Dynamic Coronary Roadmap and control group

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
371 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dynamic Coronary Roadmap group
Arm Type
Experimental
Arm Description
Patients will be treated via standard of care for PCI with navigation support of Dynamic Coronary Roadmap.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients will be treated via standard of care for PCI without navigation support of Dynamic Coronary Roadmap.
Intervention Type
Device
Intervention Name(s)
PCI with Dynamic Coronary Roadmap
Intervention Description
Standard of care PCI with Dynamic Coronary Roadmap
Intervention Type
Device
Intervention Name(s)
PCI without Dynamic Coronary Roadmap
Intervention Description
Standard of care PCI without Dynamic Coronary Roadmap
Primary Outcome Measure Information:
Title
Total PCI iodinated contrast volume
Description
Average total undiluted iodinated contrast volume (in ml) used per PCI (from first positioning the interventional guiding catheter in stable coronary position till end of PCI procedure) measured by an automatic contrast injector.
Time Frame
During PCI procedure
Secondary Outcome Measure Information:
Title
Number of angiograms
Description
Average total number of contrast enhanced cine angiographic X-ray runs (angiograms) per PCI (from first positioning the interventional guiding catheter in stable coronary position till end of PCI procedure) determined via visual assessment (e.g., on the Philips X-ray system)
Time Frame
During PCI procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Subject undergoing emergency 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 PCI with Optical Coherence Tomography (OCT) support Subject undergoing PCI with rotational or orbital atherectomy Subject with Chronic Kidney Disease (CKD) stage V (eGFR < 15 ml/min/1.73 m2) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Escaned, MD
Organizational Affiliation
San Carlos Hospital Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Columbia University Medical Center/NYPH
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Grand Hôpital de Charleroi Saint-Joseph
City
Charleroi
ZIP/Postal Code
6060
Country
Belgium
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
Facility Name
San Carlos Hospital
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Fuenlabrada University Hospital
City
Madrid
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Dynamic Coronary Roadmap for Contrast Reduction

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