Overview

This trial is active, not recruiting.

Condition coronary artery disease
Sponsor Saint Luke's Health System
Collaborator Boston Scientific Corporation
Start date December 2013
End date December 2017
Trial size 1000 participants
Trial identifier NCT02026466, OPEN CTO V1.2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.

Primary Outcomes

Measure
Health Status
time frame: One year

Secondary Outcomes

Measure
Safety and Effectiveness
time frame: One Year

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion (OPEN CTO)
Principal investigator J. Aaron Grantham, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Saint Luke's Health System.