Proximal Versus Distal Segments of No-Touch Saphenous Vein Grafts (NCT04284956) | Clinical Trial Compass
UnknownNot Applicable
Proximal Versus Distal Segments of No-Touch Saphenous Vein Grafts
China100 participantsStarted 2020-03-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Major leg wound complication at 6 days postoperatively
Timeframe: 6 days postoperatively
Trial details
NCT IDNCT04284956
SponsorChina National Center for Cardiovascular Diseases