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NCT03217006 · ClinicalTrials.gov registry record · NA

Randomization of Single vs Multiple Arterial Grafts

A NA study of Coronary Artery Disease and Heart Diseases, sponsored by Weill Medical College of Cornell University.

Active
Registry status
NA
Development phase
4,300
Enrollment target
20
Study locations

NCT03217006 is a NA study of Coronary Artery Disease and Heart Diseases that is active but no longer recruiting, run by Weill Medical College of Cornell University. The registered enrollment target is 4,300 participants, above the 1,267-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (239% higher). The trial reports 20 study locations across 7 states.

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The verdict

NCT03217006, a NA study of Coronary Artery Disease and Heart Diseases, is active but no longer recruiting, sponsored by Weill Medical College of Cornell University.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
4,300 participants
Enrollment target
20
Study locations

Study Summary

The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG, the use of two or more arterial grafts compared to a single arterial graft is associated with improved survival. Prospective event-driven unblinded randomized multicenter trial of at least 4,300 subjects enrolled in at least 25 international centers. Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG). Patients will be randomized in a 1:1 fashion between the two groups. Permuted block randomization with random blocks stratified by the center and the type of second arterial graft will be used to provide treatment distribution in equal proportion.

Conditions Studied

Coronary Artery Disease Heart Diseases

Interventions

  • PROCEDURE Single arterial graft
  • PROCEDURE Multiple arterial grafting

Study Locations (20)

Other

  • Innsbruck (Medical University) Austria - Innsbruck
  • Krankenhaus Nord Vienna North Hospital - Vienna
  • MU Vienna Austria - Vienna
  • Federal University of Sao Paulo - São Paulo
  • Hamilton General Hospital - Hamilton
  • London Health Sciences Ontario Canada - London
  • University Hospital of Montreal (CHUM) - Montreal
  • University of Ottawa Heart Institute Canada - Ottawa
  • Royal Victoria Hospital (McGill) - Québec

New York

  • NewYork-Presbyterian Brooklyn Methodist Hospital - Brooklyn
  • Icahn School of Medicine, Mount Sinai - New York
  • Weil Cornell Medical College Department of Cardiothoracic Surgery - New York
  • Lenox Hill Hospital (Northwell) - New York
  • NewYork-Presbyterian Queens - New York

Nebraska

  • Nebraska Heart Hospital - Lincoln
  • University of Nebraska Medical Center - Omaha

Colorado

  • University of Colorado - Boulder

Massachusetts

  • Baystate Health - Springfield

Ohio

  • Cleveland Clinic Foundation - Cleveland

Pennsylvania

  • Allegheny General Hospital (Cardiovascular Institute) - Pittsburgh

Trial Details

FieldValue
Enrollment Target 4,300 participants
Start Date 2018-01-07
Est. Completion 2030-01-01
Phase NA

Sponsor

Weill Medical College of Cornell University

701 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03217006

The ClinicalTrials.gov registry entry for NCT03217006 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 4,300 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,267-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (239% higher). The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which Single arterial graft is the first listed.

NCT03217006 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Other, New York, Nebraska.

Frequently Asked Questions

What is clinical trial NCT03217006 about?

NCT03217006 is a clinical study titled "Randomization of Single vs Multiple Arterial Grafts". The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, p...

What is the current status of trial NCT03217006?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 4,300 participants. The study started on 2018-01-07. Estimated completion is 2030-01-01.

What conditions does trial NCT03217006 study?

This clinical trial studies the following conditions: Coronary Artery Disease, Heart Diseases.

What interventions are being tested in trial NCT03217006?

The interventions under investigation include: Single arterial graft (PROCEDURE), Multiple arterial grafting (PROCEDURE).

Who is sponsoring clinical trial NCT03217006?

This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03217006 being conducted?

This trial has 20 study locations across Colorado, Massachusetts, Nebraska, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.