NCT04127461

Brief Summary

This is a retrospective data collection looking at patients who received either an endoscopic vessel harvesting procedure versus the conventional open procedure. Besides looking at cost variables in the 2 groups, other outcomes of interest include length of hospital stay, rates of infection, medication use, re-admissions and compilations.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
773

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

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

Study Start

First participant enrolled

September 3, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 15, 2019

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

2.3 years

First QC Date

September 24, 2019

Last Update Submit

October 11, 2019

Conditions

Coronary Bypass StenosisGraft Infection

Outcome Measures

Primary Outcomes (1)

  • cost analysis

    economic cost of open versus endoscopic vessel harvesting

    6 months

Secondary Outcomes (2)

  • Length of stay

    2 days

  • infection

    6 months

Study Arms (2)

Open vessel harvesting

ACTIVE COMPARATOR

Arm 1 is the conventional procedure

Device: Medtronic endoscope

Medtronic endoscope

EXPERIMENTAL

Arm 2 - is the minimally invasive procedure

Device: Medtronic endoscope

Interventions

Medtronic endoscopeDEVICE

The endoscope is a minimally invasive tool used to remove veins from the leg traditionally used for CABG.

Medtronic endoscopeOpen vessel harvesting

Eligibility Criteria

Age19 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • any patient at the KHSC undergoing a CABG procedure requiring a vein graft.

You may not qualify if:

  • undergoing a simultaneous procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
retrospective data collection
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Department of Surgery, Queen's University

Study Record Dates

First Submitted

September 24, 2019

First Posted

October 15, 2019

Study Start

September 3, 2016

Primary Completion

December 20, 2018

Study Completion

December 31, 2018

Last Updated

October 15, 2019

Record last verified: 2019-10