Proximal Versus Distal Segments of No-Touch Saphenous Vein Grafts

  • STATUS
    Recruiting
  • days left to enroll
    80
  • participants needed
    100
  • sponsor
    China National Center for Cardiovascular Diseases
Updated on 23 January 2021

Summary

The optimum segment of No-Touch veins for bypassing is still undefined. The purpose of this study is to assess the incidence of leg wound complication after No-Touch harvesting of proximal segment of saphenous veins compared to distal segment of veins in the leg. Graft occlusion rates between the two segments of veins for bypassing will also be compared during follow-up.

Description

This is a prospective, single-center, open-label, randomized within-subject-controlled trial. We aim to randomize 100 patients undergoing isolated coronary artery bypass graft (CABG). We consecutively screen patients during the study enrollment period and seek informed consent from all eligible patients. In each patient, one saphenous vein graft (SVG) will be randomized to be the proximal segment, while another will be the distal segment as control. Healing of leg wounds will be assessed on day 6 post-operatively. Follow-up will be performed via face-to-face interview until at least 1 year after the operation by CT angiography.

Details
Condition Leg Wound Complication After No-Touch Harvestingof Veins, Leg Wound Complication After No-Touch Harvestingof Veins
Treatment Proximal and distal segment of saphenous vein harvested by No-Touch technique
Clinical Study IdentifierNCT04284956
SponsorChina National Center for Cardiovascular Diseases
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Leg Wound Complication After No-Touch Harvestingof Veins?
Do you have any of these conditions: Do you have Leg Wound Complication After No-Touch Harvestingof Veins??
Patients aged 18 or older who undergo primary isolated open-chest CABG with two vein grafts, one to the left coronary territory and the other to the right, with or without cardiopulmonary bypass

Exclusion Criteria

Concomitant cardiac or vascular surgeries (i.e. valve repair or replacement, Maze surgery)
Redo CABG
Emergent CABG (cardiogenic shock, inotropic pressure support, IABP)
Severe vein varicosity as assessed after vein harvesting and before randomization
Use of vascular stapler for anastomosis
Endarterectomy of coronary artery during surgery
Left ventricular repair due to ventricular aneurysm
Concomitant life-threatening disease likely to limit life expectancy to less than two years
Severe renal insufficiency (i.e. creatinine >200 mol/L)
Contraindications for dual antiplatelet therapy, such as active gastroduodenal ulcer
Participant of other ongoing clinical trials
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