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Proximal Versus Distal Segments of No-Touch Saphenous Vein Grafts

Primary Purpose

Leg Wound Complication After No-Touch Harvestingof Veins

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Leg Wound Complication After No-Touch Harvestingof Veins focused on measuring leg wound complication, No-Touch saphenous vein harvesting technique, coronary artery bypass graft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Proximal group

Distal group

Arm 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

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)

Outcomes

Primary Outcome Measures

Major leg wound complication at 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

Major leg wound complication during 3-month follow-up

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

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.

Full Information

NCT ID

NCT04284956

First Posted

February 22, 2020

Last Updated

March 13, 2020

Sponsor

China National Center for Cardiovascular Diseases

1. Study Identification

Unique Protocol Identification Number

NCT04284956

Brief Title

Proximal Versus Distal Segments of No-Touch Saphenous Vein Grafts

Official Title

Major Leg Wound Complications Between the Proximal and Distal Segments of Saphenous Veins Harvested by No-Touch Technique in Coronary Artery Bypass Graft Surgery: a Single-center Randomized Within-subject Controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2020 (Actual)

Primary Completion Date

June 30, 2020 (Anticipated)

Study Completion Date

June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

China National Center for Cardiovascular Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leg Wound Complication After No-Touch Harvestingof Veins

Keywords

leg wound complication, No-Touch saphenous vein harvesting technique, coronary artery bypass graft

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Proximal group

Arm Type

Experimental

Arm 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

Arm Title

Distal group

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Major leg wound complication at 6 days postoperatively

Description

a leg wound that had failed to respond to conservative treatment and required subsequent surgical intervention such as debridement, re-suture, delayed wound closure

Time Frame

6 days postoperatively

Secondary Outcome Measure Information:

Title

Major leg wound complication during 3-month follow-up

Description

a leg wound that had failed to respond to conservative treatment and required subsequent surgical intervention such as debridement, re-suture, delayed wound closure

Time Frame

3 month

Title

Graft vessel occlusion at 3 month and 1 year

Description

Time Frame

3 months and 1 year

Other Pre-specified Outcome Measures:

Title

Major adverse cardiac or cerebrovascular events (MACCE)

Description

including cardiovascular death, non-fatal myocardial infarction (MI), stroke and target vessel revascularization

Time Frame

3 months and 1 year

Title

Individual MACCE

Description

including cardiovascular death, non-fatal myocardial infarction, stroke and target vessel revascularization

Time Frame

3 months and 1 year

Title

Recurrence of angina

Description

Events that fulfill the following definition are to be coded as Angina: i. ischemic chest pain or equivalent (e.g. arm, neck or jaw pain or discomfort thought to be related to cardiac ischemia); and ii. no evidence of MI; and iii. no clear alternative (non-cardiac) explanation (e.g. anemia, arrhythmia)

Time Frame

3 months and 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

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

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100037

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Meice Tian, M.D.

Phone

+8613718863077

tianmeice@fuwaihospital.org

First Name & Middle Initial & Last Name & Degree

Shengshou Hu, M.D.

First Name & Middle Initial & Last Name & Degree

Xianqiang Wang, M.D.

First Name & Middle Initial & Last Name & Degree

Meice Tian, M.D.

12. IPD Sharing Statement

Plan to Share IPD

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Proximal Versus Distal Segments of No-Touch Saphenous Vein Grafts

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