Clinical trial NCT04284956: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Leg Wound Complication After No-Touch Harvestingof Veins
Keywords: leg wound complication
No-Touch saphenous vein harvesting technique
coronary artery bypass graft
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2020-02-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Major leg wound complication at 6 days postoperatively
timeFrame: 6 days postoperatively
Secondary outcomes:
measure: Major leg wound complication during 3-month follow-up
timeFrame: 3 month
measure: Graft vessel occlusion at 3 month and 1 year
timeFrame: 3 months and 1 year
Other outcomes:
measure: Major adverse cardiac or cerebrovascular events (MACCE)
timeFrame: 3 months and 1 year
measure: Individual MACCE
timeFrame: 3 months and 1 year
measure: Recurrence of angina
timeFrame: 3 months and 1 year
Locations:
city: Beijing
country: China
facility: Fuwai Hospital Chinese Academay of Medical Science and National Center for Cardiovascular Diseases
state: Beijing
Study officials:
References: