Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Chronic Total Occlusion
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.
Detailed 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.
Interventions
None listed
Sponsors
Boston Scientific Corporation
Saint Luke's Health System
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Safety and Effectiveness | One Year | Describe safety and effectiveness among patients receiving CTO-PCI |
Countries
United States
Outcome results
None listed