Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CAD with CTO<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Status | 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 | Describe safety and effectiveness among patients receiving CTO-PCI | One Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Chronic Total Occlusion