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 : May 4, 2018
|Condition or disease|
|Coronary Artery Disease|
- 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 [Patient Registry]|
|Actual Enrollment :||1000 participants|
|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|
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.
- 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.
- Safety and Effectiveness [ Time Frame: One Year ]Describe safety and effectiveness among patients receiving CTO-PCI
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
|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, Pennsylvania, United States, 17405|
|United States, Washington|
|University of Washington Medical Center|
|Seattle, Washington, United States, 91895|
|Principal Investigator:||J. Aaron Grantham, MD||Saint Luke's Health System|