Proximal Versus Distal Segments of No-Touch Saphenous Vein Grafts

NCT ID: NCT04284956

Last Updated: 2020-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2021-06-30

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.

Conditions

Leg Wound Complication After No-Touch Harvestingof Veins

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Proximal group

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

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

two longitudinal incisions are made on the thigh and shank from unilateral lower limb (for harvesting of proximal segment of saphenous vein, incision is started from about 3 or 4cms inferolateral to the pubic tubercle and then extended downward). As previous reported. the adventitia and perivascular tissue are carefully kept intact to avoid damage. Then a margin of about 5 mm from both sides of the vein is created to include the fat pedicle using electrocautery, and all visible side branches are ligated with 4-0 silk or by metal clipping (branches are divided at the pedicle margin rather than the vein trunk). The saphenous vein is then separated from its bed using scissors and electrocautery, together with surrounding tissue.

Distal group

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)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

two longitudinal incisions are made on the thigh and shank from unilateral lower limb (for harvesting of proximal segment of saphenous vein, incision is started from about 3 or 4cms inferolateral to the pubic tubercle and then extended downward). As previous reported. the adventitia and perivascular tissue are carefully kept intact to avoid damage. Then a margin of about 5 mm from both sides of the vein is created to include the fat pedicle using electrocautery, and all visible side branches are ligated with 4-0 silk or by metal clipping (branches are divided at the pedicle margin rather than the vein trunk). The saphenous vein is then separated from its bed using scissors and electrocautery, together with surrounding tissue.

Interventions

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

two longitudinal incisions are made on the thigh and shank from unilateral lower limb (for harvesting of proximal segment of saphenous vein, incision is started from about 3 or 4cms inferolateral to the pubic tubercle and then extended downward). As previous reported. the adventitia and perivascular tissue are carefully kept intact to avoid damage. Then a margin of about 5 mm from both sides of the vein is created to include the fat pedicle using electrocautery, and all visible side branches are ligated with 4-0 silk or by metal clipping (branches are divided at the pedicle margin rather than the vein trunk). The saphenous vein is then separated from its bed using scissors and electrocautery, together with surrounding tissue.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fuwai Hospital Chinese Academay of Medical Science and National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Meice Tian, M.D.

Role: primary

tianmeice@fuwaihospital.org

+8613718863077

Other Identifiers

2019-F06

Identifier Type: -

Identifier Source: org_study_id