NCT02385344

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,046

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

Geographic Reach
6 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
21 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 7, 2018

Status Verified

September 1, 2018

Enrollment Period

2.7 years

First QC Date

February 17, 2015

Last Update Submit

September 6, 2018

Conditions

Coronary Artery Bypass

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (3)

  • Record number of revisions

    Day 1 (During surgery)

  • Record number of events

    Day 1-14 (During hospitalization)

  • Incidence rate

    2 years (Throughout the study)

Interventions

Medistim deviceDEVICE

This registry is intended to document surgical findings, procedural changes, and adverse events occurring prior to discharge

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subject has been scheduled for coronary bypass surgery

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Veterans Affairs Medical Center

Washington DC, Maryland, 20422, United States

Location

Mount Sinai Beth Israel

New York, New York, 10003, United States

Location

University of Calgary

Calgary, Alberta, AB T2N 1N4, Canada

Location

University of Duisburg-Essen, Dept. of Cardiothoracic Surgery

Essen, 45122, Germany

Location

Clinica Cardiochirurgica

Chieti, 66100, Italy

Location

Erasmus University Medical Center

Rotterdam, 3015 GD, Netherlands

Location

University of Oxford

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (3)

  • Leviner DB, von Mucke Similon M, Rosati CM, Amabile A, Thuijs DJFM, Giammarco GD, Wendt D, Trachiotis GD, Kieser TM, Kappetein AP, Head SJ, Taggart DP, Puskas JD. Transit time flow measurement of coronary bypass grafts before and after protamine administration. J Cardiothorac Surg. 2021 Jul 9;16(1):195. doi: 10.1186/s13019-021-01575-y.

    PMID: 34243799DERIVED

  • Rosenfeld ES, Trachiotis GD, Napolitano MA, Sparks AD, Wendt D, Kieser TM, Puskas JD, DiGiammarco G, Taggart DP. Intraoperative transit-time flow measurement and high-frequency ultrasound in coronary artery bypass grafting: impact in off versus on-pump, arterial versus venous grafting and cardiac territory grafted. Eur J Cardiothorac Surg. 2021 Dec 27;61(1):204-213. doi: 10.1093/ejcts/ezab239.

    PMID: 34166508DERIVED

  • Rosenfeld ES, Trachiotis GD, Sparks AD, Napolitano MA, Lee KB, Wendt D, Kieser TM, Puskas JD, DiGiammarco G, Taggart DP. Intraoperative surgical strategy changes in patients with chronic and end-stage renal disease undergoing coronary artery bypass grafting. Eur J Cardiothorac Surg. 2021 Jun 14;59(6):1210-1217. doi: 10.1093/ejcts/ezab104.

    PMID: 33675642DERIVED

Study Officials

  • Anne Waaler, MSc Pharm

    Medistim ASA

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2015

First Posted

March 11, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

September 7, 2018

Record last verified: 2018-09

Locations

DE(1)GB(1)CA(1)US(2)IT(1)NL(1)