No-Touch Versus Conventional Saphenous Vein Harvesting Technique

NCT03126409 · tracked via the Priya Life Science China tracker

Sponsor

China National Center for Cardiovascular Diseases

Phase

Not applicable

Started

2017-05-14

Last updated

2024-10-04

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

No-Touch vein harvesting techniqueConventional vein harvesting

No-Touch vein harvesting technique: The No-Touch technique focuses on saphenous vein graft harvesting, featured by preserving the surrounding tissue of the vein while at the same time avoiding manual distension.

Conventional vein harvesting: During saphenous vein harvesting, surrounding tissue of the vein is stripped off, and manual distension is routinely performed

Study summary

This study evaluates the short-term patency of vein graft harvested by the No-Touch technique compared to that by the conventional approach in patients undergoing isolated on-pump/off-pump coronary artery bypass graft (CABG) surgery. a total of at least 2000 patients undergoing isolated on-pump/off-pump CABG will be consecutively recruited from 7 hospitals across China and randomly assigned to receive No-Touch saphenous vein harvesting or conventional approach. All participants will be invited for clinical follow-up and 64-slice multislice computed tomography angiography (MSCTA) analysis at 3 months post-operatively.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patients receiving first time isolated on-pump/off-pump CABG * Patients with at least one available saphenous vein graft Exclusion Criteria: * Need for a concomitant cardiac or vascular surgeries (i.e. valve repair or replacement, Maze surgery) * Redo-CABG * Emergent CABG * Using vascular stapler for anastomosis * Endarterectomy of coronary artery during surgery * Left ventricular repair due to ventricular aneurysm * Combined with malignant tumor or other severe systemic conditions * Severe renal insufficiency (i.e. creatinine \>200 μmol/L) * Contraindications for dual antiplatelet therapy, such as active gastroduodenal ulcer * Participants of another ongoing clinical trials

Primary outcome measure(s)

Prevalence of graft occlusion — 3 month after procedure
All participants will be invited to return to their operating hospitals for 64-slice multi-slice computed tomography angiography to determine patencies of the graft vessels.

Trial sites (1)

Facility	City	Region	Status
Fuwai Hospital Chinese Academay of Medical Science and National Center for Cardiovascular Diseases	Beijing	Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03126409 on ClinicalTrials.gov ↗ ← All trials in China