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DCR4Contrast: Dynamic Coronary Roadmap for Contrast Reduction

Sponsor
Philips Clinical & Medical Affairs Global (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04085614
Collaborator
(none)
394
Enrollment
6
Locations
2
Arms
41
Anticipated Duration (Months)
65.7
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: PCI with Dynamic Coronary Roadmap
  • Device: PCI without Dynamic Coronary Roadmap
 N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
394 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Dynamic Coronary Roadmap for Contrast Reduction
Actual Study Start Date :
Oct 1, 2019
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dynamic Coronary Roadmap group

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

Device: PCI with Dynamic Coronary Roadmap
Standard of care PCI with Dynamic Coronary Roadmap
Active Comparator: Control group

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

Device: PCI without Dynamic Coronary Roadmap
Standard of care PCI without Dynamic Coronary Roadmap

Outcome Measures

Primary Outcome Measures

  1. Total PCI iodinated contrast volume [During PCI procedure]

    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

  1. Number of angiograms [During PCI procedure]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Colorado Hospital Denver Colorado United States 80045
2 Columbia University Medical Center/NYPH New York New York United States 10032
3 Grand Hôpital de Charleroi Saint-Joseph Charleroi Belgium 6060
4 Hadassah Medical Center Jerusalem Israel
5 San Carlos Hospital Madrid Spain 28040
6 Fuenlabrada University Hospital Madrid Spain

Sponsors and Collaborators

  • Philips Clinical & Medical Affairs Global

Investigators

  • Principal Investigator: Javier Escaned, MD, San Carlos Hospital Madrid

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Philips Clinical & Medical Affairs Global
ClinicalTrials.gov Identifier:
NCT04085614
Other Study ID Numbers:
  • XCY612-130576
First Posted:
Sep 11, 2019
Last Update Posted:
Jun 28, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Coronary Artery Disease

Study Results

No Results Posted as of Jun 28, 2022