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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.
* 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Banner Heart Hospital
Mesa, Arizona, United States
Banner Good Samaritan
Phoenix, Arizona, United States
Torrance Memorial Medical Center
Torrance, California, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
Boone Hospital Center
Columbia, Missouri, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Presbyterian Health System Hospital
Albuquerque, New Mexico, United States
Columbia University Medical Center
New York, New York, United States
Peace Health Sacred Heart River Bend Medical Center
Springfield, Oregon, United States
York Hospital
York, Pennsylvania, United States
Start Date
December 1, 2013
Primary Completion Date
September 1, 2017
Completion Date
December 1, 2017
Last Updated
October 19, 2021
1,000
ACTUAL participants
Lead Sponsor
Saint Luke's Health System
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT01311323