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

Saint Luke's Health System

Status: Completed

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02026466

OPEN CTO V1.2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 1 patient group

CAD with CTO

Description:

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.