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

Coronary Artery Bypass Clinical Trial

— REQUEST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02385344
• Other study ID #: 1501
• Status: Completed
• Start date: April 2015
• Est. completion date: December 2017

Study information

• Verified date: September 2018
• Source: Medistim ASA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1046
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Bypass

Intervention

Device:
• Medistim device
This registry is intended to document surgical findings, procedural changes, and adverse events occurring prior to discharge

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Germany	University of Duisburg-Essen, Dept. of Cardiothoracic Surgery	Essen
Italy	Clinica Cardiochirurgica	Chieti
Netherlands	Erasmus University Medical Center	Rotterdam
United Kingdom	University of Oxford	Oxford
United States	Mount Sinai Beth Israel	New York	New York
United States	Veterans Affairs Medical Center	Washington DC	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Medistim ASA

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in planned surgical procedure	Identify how often epiaortic scanning With the Medistim Device, leads to a change in the planned surgical procedure and to identify the reason and the procedure change	Day 1 (During Surgery)
Primary	Procedure adaptions	Identify the procedure adaptions made by a surgeon when TTFM and/or Medistim ultrasound imaging identify suboptimal graft function	Day 1 (During surgery)
Secondary	Record number of revisions	Record how many Cardiac bypass patients experience intraoperative graft revision, the type of revision, and the key identifier motivating the revision	Day 1 (During surgery)
Secondary	Record number of events	Record post-surgical major adverse cardiac and cerebral events (MACCE) of all bypass procedure patients entered into the registry and occuring prior to discharge	Day 1-14 (During hospitalization)
Secondary	Incidence rate	To determine the incidence rate of Serious Adverse Events (SAE) and/or Unanticipated Adverse Events (UAE) throughout the registry	2 years (Throughout the study)