Registry for Quality Assessment With Ultrasound Imaging and TTFM in Cardiac Bypass Surgery (REQUEST)

Medistim

Status: Completed

Conditions: Coronary Artery Bypass

Treatments: Device: Medistim device

Study type: Observational

Funder types: Industry

Identifiers

NCT02385344

1501

Details and patient eligibility

About

The purpose of the registry is to collect information regarding the number and type of coronary artery bypass (CAB) surgical procedure changes that are made based on intraoperative guidance information using transit time flow measurements (TTFM) and ultrasound image capabilities provided with the Medistim device.

Enrollment: 1,046 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has been scheduled for coronary bypass surgery
• Subject understands the nature of the procedure and has signed the subject informed consent prior to the procedure
• Subject has been diagnosed with 2-3 vessel disease

Exclusion criteria

• Subject is scheduled for other surgical procedures during the bypass surgery (valve replacement/repair, carotid endarterectomy, etc.)
• Subject is known to be suffering from any psychological, developmental, physical, or emotional disorder that the investigator feels would interfere with surgery or follow-up testing
• Subject is undergoing an emergency cardiac bypass surgery
• Subject has history or presence of muscle disease (i.e. myopathy, myalgia, myasthenia, rhabdomyolysis) with or without concomitant CK-elevation > 5 ULN that cannot be ascribed to any other medical condition (e.g. myocardial infarction)
• Subject has any condition that the investigator believes should exclude him/her from this registry