Leg Wound Complication After No-Touch Harvestingof Veins Clinical Trial
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
NCT number | NCT04284956 |
Other study ID # | 2019-F06 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2020 |
Est. completion date | June 30, 2021 |
Verified date | March 2020 |
Source | China National Center for Cardiovascular Diseases |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 30, 2021 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Fuwai Hospital Chinese Academay of Medical Science and National Center for Cardiovascular Diseases | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
China National Center for Cardiovascular Diseases |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Major adverse cardiac or cerebrovascular events (MACCE) | including cardiovascular death, non-fatal myocardial infarction (MI), stroke and target vessel revascularization | 3 months and 1 year | |
Other | Individual MACCE | including cardiovascular death, non-fatal myocardial infarction, stroke and target vessel revascularization | 3 months and 1 year | |
Other | Recurrence of angina | 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) |
3 months and 1 year | |
Primary | 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 | 6 days postoperatively | |
Secondary | 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 | 3 month | |
Secondary | 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. | 3 months and 1 year |