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Hybrid Revascularization Observational Study

NCT01121263 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 298

Last updated 2014-03-14

Study results available
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Summary

The purpose of the study is to get a better understanding of patients who have multi-vessel coronary artery disease (blockages in more than one vessel bringing blood to the heart) and have either Hybrid Coronary Revascularization \[HCR\] (combination of surgery and catheter procedures to open up clogged heart arteries) or Percutaneous Coronary Intervention \[PCI\] (catheter procedures to open up clogged heart arteries). Participation in the study will last up to 21 months after a patient's heart procedure(s). The study collects information about the medical care patients receive during their planned procedure(s) and how well they do following the procedure(s). No new testing or procedures will be done. Patients will receive only the tests or procedures their doctor already has planned for them. The information collected should help to plan the design of a pivotal comparative effectiveness study of hybrid revascularization.

Conditions

Sponsors & Collaborators

  • International Center for Health Outcomes and Innovation Research

    collaborator OTHER

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Icahn School of Medicine at Mount Sinai

    lead OTHER

Principal Investigators

  • John Puskas, MD, MSc, FACS, FACC · Emory University

  • Deborah Ascheim, MD · Icahn School of Medicine at Mount Sinai (Data Coordinating Center)

  • Joseph J DeRose, MD, FACS · Montefiore Medical Center

  • Michael Argenziano, MD, FACS · Columbia University

  • Mathew Williams, MD · Columbia University

  • John G. Byrne, MD · Vanderbilt University Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-08-31
Completion
2013-08-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01121263 on ClinicalTrials.gov