Proximal Versus Distal Segments of No-Touch Saphenous Vein Grafts

Not Applicable

• Conditions: Leg Wound Complication After No-Touch Harvestingof Veins
• Interventions: Procedure: Proximal and distal segment of saphenous vein harvested by No-Touch technique

• Registration Number: NCT04284956
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-02-22
• Study First Submitted QC: 2020-02-25
• Study First Posted: 2020-02-26
• Status Verified: 2020-03
• Study Start: 2020-03-01
• Last Update Submitted: 2020-03-13
• Last Update Posted: 2020-03-17
• Primary Completion: 2020-06-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Distal group	Proximal and distal segment of saphenous vein harvested by No-Touch technique	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)
Proximal group	Proximal and distal segment of saphenous vein harvested by No-Touch technique	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

Primary Outcome Measures

Name	Time	Method
Major leg wound complication at 6 days postoperatively	6 days postoperatively	a leg wound that had failed to respond to conservative treatment and required subsequent surgical intervention such as debridement, re-suture, delayed wound closure

Secondary Outcome Measures

Name	Time	Method
Major leg wound complication during 3-month follow-up	3 month	a leg wound that had failed to respond to conservative treatment and required subsequent surgical intervention such as debridement, re-suture, delayed wound closure
Graft vessel occlusion at 3 month and 1 year	3 months and 1 year	Graft occlusion is detected by multislice computed tomography angiography (MSCTA). Graft assessment is conducted according to the FitzGibbon criteria. Each graft is graded as A (excellent), B (fair), or O (occluded). Contrast filling of the grafts, anastomoses, and coronary arteries beyond the graft are considered in each assessment. Grade A indicates that the graft is patent with ≤50% stenosis. Grade B indicates that graft stenosis is \>50% but not occluded. When a conduit does not fill with contrast at all, it is considered Grade O and included with string sign found in any segment (including proximal anastomotic site, distal anastomotic site, and main trunk). Both of these latter findings are considered together and referred to as occlusion in the analysis.

Trial Locations

Locations (1)

Fuwai Hospital Chinese Academay of Medical Science and National Center for Cardiovascular Diseases; 🇨🇳 Beijing, Beijing, China