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Pedicled "no-touch" SVG harvesting for Coronary Artery Disease

Phase 1
Waitlist Available
Led By Stephen Fremes, MD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months postoperatively
Awards & highlights

Summary

The purpose of this study is to compare saphenous veins harvested using the atraumatic pedicled ("no-touch") technique to saphenous veins harvested using the conventional open technique in patients undergoing isolated coronary artery bypass surgery. Investigators will compare the biological structure of the saphenous veins harvested using these two techniques. There is some evidence that saphenous veins harvested using the "no-touch" technique may allow for better patency up to 8 years following bypass surgery. We may be able to detect early differences in vascular structure, observed at the time of conduit harvest.

Eligible Conditions
  • Coronary Artery Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Biological Properties
Secondary study objectives
Leg wound Healing and Leg Functional Outcome

Side effects data

From 2020 Phase 4 trial • 777 Patients • NCT01985360
19%
Death from any cause or Initiation of dialysis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Invasive Strategy
Conservative Strategy

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pedicled "no-touch" SVG harvestingExperimental Treatment1 Intervention
Saphenous vein harvested with a pedicle of surrounding fat and distension with heparinized blood at arterial pressure. No manual distention.
Group II: Conventional open SVG harvestingActive Control2 Interventions
Saphenous vein is harvested with an open technique, stripped of adventitia, and manually distended with crystalloid solution.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Coronary Artery Bypass Graft Surgery
2010
Completed Phase 4
~800

Find a Location

Who is running the clinical trial?

Unity Health TorontoOTHER
556 Previous Clinical Trials
454,391 Total Patients Enrolled
6 Trials studying Coronary Artery Disease
5,998 Patients Enrolled for Coronary Artery Disease
Sunnybrook Health Sciences CentreLead Sponsor
672 Previous Clinical Trials
1,565,822 Total Patients Enrolled
11 Trials studying Coronary Artery Disease
4,182 Patients Enrolled for Coronary Artery Disease
Stephen Fremes, MDPrincipal InvestigatorSunnybrook Health Sciences Centre
3 Previous Clinical Trials
6,550 Total Patients Enrolled
3 Trials studying Coronary Artery Disease
6,550 Patients Enrolled for Coronary Artery Disease
~1 spots leftby Oct 2025
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