Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion
This trial is active, not recruiting.
|Condition||coronary artery disease|
|Sponsor||Saint Luke's Health System|
|Collaborator||Boston Scientific Corporation|
|Start date||December 2013|
|End date||December 2017|
|Trial size||1000 participants|
|Trial identifier||NCT02026466, OPEN CTO V1.2|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Mesa, AZ||Banner Heart Hospital||no longer recruiting|
|Phoenix, AZ||Banner Good Samaritan||no longer recruiting|
|Torrance, CA||Torrance Memorial Medical Center||no longer recruiting|
|Elk Grove Village, IL||Alexian Brothers Medical Center||no longer recruiting|
|Columbia, MO||Boone Hospital Center||no longer recruiting|
|Kansas City, MO||Saint Luke's Hospital of Kansas City||no longer recruiting|
|Albuquerque, NM||Presbyterian Health System Hospital||no longer recruiting|
|New York City, NY||Columbia University Medical Center||no longer recruiting|
|Springfield, OR||Peace Health Sacred Heart River Bend Medical Center||no longer recruiting|
|York, PA||York Hospital||no longer recruiting|
|Seattle, WA||University of Washington Medical Center||no longer recruiting|
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.
time frame: One year
Safety and Effectiveness
time frame: One Year
Male or female participants at least 18 years old.
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.
|Official title||Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion (OPEN CTO)|
|Principal investigator||J. Aaron Grantham, MD|
|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.|
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