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

Completed

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT02026466

Run by

Saint Luke's Health System

People needed

1000

Starts

2013-12-01

Expected to finish

2017-12-01

Last updated by the study team

2021-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Banner Heart Hospital — Mesa, Arizona, United States
• Banner Good Samaritan — Phoenix, Arizona, United States
• Torrance Memorial Medical Center — Torrance, California, 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
• Columbia University Medical Center — New York, New York, United States
• Peace Health Sacred Heart River Bend Medical Center — Springfield, Oregon, United States
• York Hospital — York, Pennsylvania, United States
• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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