No-Touch Versus Conventional Saphenous Vein Harvesting Technique

NCT03126409 | Active Not Recruiting DMC

• 1 other identifier: 20170414
• Study Type: interventional
• Target: 2,655
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Keywords

coronary artery disease; coronary artery bypass graft

Outcome Measures

Primary Outcomes (1)

• Prevalence of graft occlusion

  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.

  3 month after procedure

Secondary Outcomes (8)

• Prevalence of graft occlusion

  1, 3, 5, 7, and 10 years after procedure

• Overall major adverse cardiac or cerebrovascular events (MACCE) rate

  3 month , 1, 3, 5, 7, and 10 years after procedure

• Cardiac death

  3 month , 1, 3, 5, 7, and 10 years after procedure

• Documented non-lethal myocardial infarction

  3 month , 1, 3, 5, 7, and 10 years after procedure

• Stroke

  3 month , 1, 3, 5, 7, and 10 years after procedure

Study Arms (2)

No-Touch vein harvesting technique

EXPERIMENTAL

During saphenous vein harvesting, surrounding tissue of the vein is preserved, and manual distension of the vein graft is avoided

Procedure: No-Touch vein harvesting technique

Conventional vein harvesting

ACTIVE COMPARATOR

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

Procedure: Conventional vein harvesting

Interventions

No-Touch vein harvesting technique PROCEDURE

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.

No-Touch vein harvesting technique

Conventional vein harvesting PROCEDURE

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

Conventional vein harvesting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients receiving first time isolated on-pump/off-pump CABG
• Patients with at least one available saphenous vein graft

You may not qualify if:

• 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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (3)

• Wang X, Tian M, Zheng Z, Gao H, Wang Y, Wang L, Hu S. Rationale and design of a multicenter randomized trial to compare the graft patency between no-touch vein harvesting technique and conventional approach in coronary artery bypass graft surgery. Am Heart J. 2019 Apr;210:75-80. doi: 10.1016/j.ahj.2018.11.011. Epub 2018 Dec 6.

  PMID: 30743210 BACKGROUND

• Tian M, Wang X, Feng W, Wang H, Liu S, Liu Z, Chen Y, Miao Q, Su P, Li X, Wang Y, Lu B, Chen K, Zhang C, Hu S. No-touch versus conventional vein in coronary artery bypass grafting: three year follow-up of multicentre randomised PATENCY trial. BMJ. 2025 Apr 30;389:e082883. doi: 10.1136/bmj-2024-082883.

  PMID: 40306935 DERIVED

• Tian M, Wang X, Sun H, Feng W, Song Y, Lu F, Wang L, Wang Y, Xu B, Wang H, Liu S, Liu Z, Chen Y, Miao Q, Su P, Yang Y, Guo S, Lu B, Sun Z, Liu K, Zhang C, Wu Y, Xu H, Zhao W, Han C, Zhou X, Wang E, Huo X, Hu S. No-Touch Versus Conventional Vein Harvesting Techniques at 12 Months After Coronary Artery Bypass Grafting Surgery: Multicenter Randomized, Controlled Trial. Circulation. 2021 Oct 5;144(14):1120-1129. doi: 10.1161/CIRCULATIONAHA.121.055525. Epub 2021 Sep 13.

  PMID: 34510911 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 24, 2017
• Study Start: May 14, 2017
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)