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ACTIVE NOT RECRUITING NA

Randomization of Single vs Multiple Arterial Grafts

NCT03217006 · View on ClinicalTrials.gov ↗

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.

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

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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 4,300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 679 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03217006 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, New York, Nebraska. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03217006?

The interventions under investigation include: Single arterial graft (PROCEDURE), Multiple arterial grafting (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03217006?

This trial is sponsored by Weill Medical College of Cornell University, which has 679 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial