Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion (OPEN-CTO)

October 14, 2021 updated by: Saint Luke's Health System

Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion (OPEN CTO)

This is an observational registry, sponsored by Saint Luke's Hospital. This study is to be conducted according to DHHS Guidelines, applicable state regulations, and local IRB policies and procedures. The overall objective is to address current gaps in knowledge regarding CTO-PCI, as a prospective, multi-center, single-arm study of 1,000 participants.

Study Overview

Status

Completed

Conditions

Detailed Description

  • 1,000 participants will be enrolled into the OPEN CTO study.
  • Study coordinators will screen both men and women over the age of 18 who are admitted for an elective CTO-PCI procedure.
  • Study coordinators will be trained by the Coordinating Center at Saint Luke's Hospital of Kansas City.
  • Participants will be screened for Eligibility, and Informed Consent will be obtained.
  • Participants will also be asked to sign a Medical Records Release form, and a Billing Records Release form.
  • Detailed procedural data will be obtained by the Study Coordinator and local Principal Investigator.
  • Participants will undergo a Baseline interview.
  • These data will be entered into the electronic data capture system, Velos, which has stringent protections and quality controls.
  • Participants will have telephone follow-up interviews conducted by the centralized Follow-up Center at Saint Luke's Hospital.

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Banner Heart Hospital
      • Phoenix, Arizona, United States, 85006
        • Banner Good Samaritan
    • California
      • Torrance, California, United States, 90505
        • Torrance Memorial Medical Center
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Alexian Brothers Medical Center
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Boone Hospital Center
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Presbyterian Health System Hospital
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
    • Oregon
      • Springfield, Oregon, United States, 94777
        • Peace Health Sacred Heart River Bend Medical Center
    • Pennsylvania
      • York, Pennsylvania, United States, 17405
        • York Hospital
    • Washington
      • Seattle, Washington, United States, 91895
        • University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

18 or older with CAD and at least one chronic total occluded vessel.

Description

Inclusion Criteria:

  • Subject is scheduled for a PCI procedure for at least one chronic total occlusion with TIMI antegrade flow of zero.
  • Subject is ≥ 18 years of age at the time of consent.

Exclusion Criteria:

  • The CTO segment is in a graft
  • Female subjects with a positive quantitative or qualitative pregnancy test, in accordance with hospital policy.
  • Non-English speaking
  • Too hard of hearing to do follow-up by telephone.
  • Previously enrolled in OPEN CTO Registry
  • Currently a prisoner
  • Dementia
  • Subjects with no way contact by telephone for follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
CAD with CTO
Subjects will have Coronary Artery Disease with a diagnosed Chronic Total Occlusion: a coronary artery with TIMI flow of zero(no flow) for at least three months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Status
Time Frame: One year
Quantify the baseline health status effects of CTO among patients selected for CTO-PCI and quantify the changes associated with CTO-PCI using the Hybrid Approach.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Effectiveness
Time Frame: One Year
Describe safety and effectiveness among patients receiving CTO-PCI
One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Luke's Health System

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: J. Aaron Grantham, MD, Saint Luke's Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

November 26, 2013

First Submitted That Met QC Criteria

December 31, 2013

First Posted (Estimate)

January 3, 2014

Study Record Updates

Last Update Posted (Actual)

October 19, 2021

Last Update Submitted That Met QC Criteria

October 14, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPEN CTO V1.2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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