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

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT02026466
• Lead Sponsor: Saint Luke's Health System

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.

Study Timeline

• Study First Submitted: 2013-11-26
• Study Start: 2013-12
• Study First Submitted QC: 2013-12-31
• Study First Posted: 2014-01-03
• Primary Completion: 2017-09
• Study Completion: 2017-12
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Safety and Effectiveness	One Year	Describe safety and effectiveness among patients receiving CTO-PCI

Trial Locations

Locations (11)

Torrance Memorial Medical Center; 🇺🇸 Torrance, California, United States

Banner Good Samaritan; 🇺🇸 Phoenix, Arizona, United States

York Hospital; 🇺🇸 York, Pennsylvania, United States

Banner Heart Hospital; 🇺🇸 Mesa, Arizona, United States

Alexian Brothers Medical Center; 🇺🇸 Elk Grove Village, Illinois, United States

Boone Hospital Center; 🇺🇸 Columbia, Missouri, United States

Saint Luke's Hospital of Kansas City; 🇺🇸 Kansas City, Missouri, United States

Presbyterian Health System Hospital; 🇺🇸 Albuquerque, New Mexico, United States

Peace Health Sacred Heart River Bend Medical Center; 🇺🇸 Springfield, Oregon, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States