OPEN-CTO: Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion
Study Details
Study Description
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 | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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1,000 participants will be enrolled into the OPEN CTO study.
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Study coordinators will screen both men and women over the age of 18 who are admitted for an elective CTO-PCI procedure.
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Study coordinators will be trained by the Coordinating Center at Saint Luke's Hospital of Kansas City.
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Participants will be screened for Eligibility, and Informed Consent will be obtained.
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Participants will also be asked to sign a Medical Records Release form, and a Billing Records Release form.
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Detailed procedural data will be obtained by the Study Coordinator and local Principal Investigator.
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Participants will undergo a Baseline interview.
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These data will be entered into the electronic data capture system, Velos, which has stringent protections and quality controls.
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Participants will have telephone follow-up interviews conducted by the centralized Follow-up Center at Saint Luke's Hospital.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
Primary Outcome Measures
- Health Status [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
- Safety and Effectiveness [One Year]
Describe safety and effectiveness among patients receiving CTO-PCI
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is scheduled for a PCI procedure for at least one chronic total occlusion with TIMI antegrade flow of zero.
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Subject is ≥ 18 years of age at the time of consent.
Exclusion Criteria:
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The CTO segment is in a graft
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Female subjects with a positive quantitative or qualitative pregnancy test, in accordance with hospital policy.
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Non-English speaking
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Too hard of hearing to do follow-up by telephone.
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Previously enrolled in OPEN CTO Registry
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Currently a prisoner
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Dementia
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Subjects with no way contact by telephone for follow-up.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Banner Heart Hospital | Mesa | Arizona | United States | 85206 |
| 2 | Banner Good Samaritan | Phoenix | Arizona | United States | 85006 |
| 3 | Torrance Memorial Medical Center | Torrance | California | United States | 90505 |
| 4 | Alexian Brothers Medical Center | Elk Grove Village | Illinois | United States | 60007 |
| 5 | Boone Hospital Center | Columbia | Missouri | United States | 65201 |
| 6 | Saint Luke's Hospital of Kansas City | Kansas City | Missouri | United States | 64111 |
| 7 | Presbyterian Health System Hospital | Albuquerque | New Mexico | United States | 87106 |
| 8 | Columbia University Medical Center | New York | New York | United States | 10032 |
| 9 | Peace Health Sacred Heart River Bend Medical Center | Springfield | Oregon | United States | 94777 |
| 10 | York Hospital | York | Pennsylvania | United States | 17405 |
| 11 | University of Washington Medical Center | Seattle | Washington | United States | 91895 |
Sponsors and Collaborators
- Saint Luke's Health System
- Boston Scientific Corporation
Investigators
- Principal Investigator: J. Aaron Grantham, MD, Saint Luke's Health System
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OPEN CTO V1.2