Proximal Versus Distal Segments of No-Touch Saphenous Vein Grafts

National Center for Cardiovascular Diseases

Status: Unknown

Conditions: Leg Wound Complication After No-Touch Harvestingof Veins

Treatments: Procedure: Proximal and distal segment of saphenous vein harvested by No-Touch technique

Study type: Interventional

Funder types: Other

Identifiers

NCT04284956

2019-F06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 μmol/L)
• Contraindications for dual antiplatelet therapy, such as active gastroduodenal ulcer
• Participant of other ongoing clinical trials

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Proximal group

Experimental group

Description:

Proximal segment of saphenous veins are harvested from the thigh by No-Touch technique and randomized to bypass the left or right territory of coronary system

Treatment:

Procedure: Proximal and distal segment of saphenous vein harvested by No-Touch technique

Distal group

Active Comparator group

Description:

Distal segment of saphenous veins are harvested from the shank of the ipsilateral leg by No-Touch technique and used to bypass the right or left territory of coronary system (depending on the randomizing result of the proximal segments)

Treatment:

Procedure: Proximal and distal segment of saphenous vein harvested by No-Touch technique