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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02026466
Recruitment Status : Completed
First Posted : January 3, 2014
Last Update Posted : October 19, 2021
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Saint Luke's Health System

Study Description
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Brief Summary:
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.

Condition or disease
Coronary Artery Disease

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 Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion (OPEN CTO)
Actual Study Start Date : December 2013
Actual Primary Completion Date : September 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Safety and Effectiveness [ Time Frame: One Year ]
    Describe safety and effectiveness among patients receiving CTO-PCI


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
18 or older with CAD and at least one chronic total occluded vessel.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02026466


Locations
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United States, Arizona
Banner Heart Hospital
Mesa, Arizona, United States, 85206
Banner Good Samaritan
Phoenix, Arizona, United States, 85006
United States, California
Torrance Memorial Medical Center
Torrance, California, United States, 90505
United States, Illinois
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States, 60007
United States, Missouri
Boone Hospital Center
Columbia, Missouri, United States, 65201
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
United States, New Mexico
Presbyterian Health System Hospital
Albuquerque, New Mexico, United States, 87106
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Oregon
Peace Health Sacred Heart River Bend Medical Center
Springfield, Oregon, United States, 94777
United States, Pennsylvania
York Hospital
York, Pennsylvania, United States, 17405
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 91895
Sponsors and Collaborators
Saint Luke's Health System
Boston Scientific Corporation
Investigators
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Principal Investigator: J. Aaron Grantham, MD Saint Luke's Health System
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Saint Luke's Health System
ClinicalTrials.gov Identifier: NCT02026466    
Other Study ID Numbers: OPEN CTO V1.2
First Posted: January 3, 2014    Key Record Dates
Last Update Posted: October 19, 2021
Last Verified: October 2021
Keywords provided by Saint Luke's Health System:
Coronary Artery Disease
Chronic Total Occlusion
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases