A Clinical Trial on No-touch Vein Graft (NT-graft) in Coronary Surgery

NCT ID: NCT03501303

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 902 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-20
• Study Completion Date: 2023-11-17

Brief Summary

The primary objective in this study is to investigate if vein grafts harvested and implanted with the non-touch technique are superior to conventional vein graft technique with respect to mid-term patency, in patients undergoing CABG surgery.

Detailed Description

Coronary artery bypass grafting (CABG) is the most common surgical procedure aimed against ischemic heart disease (IHD) in Sweden. Early and late success of CABG is the result of sustained patency of the bypass grafts. The choice of conduit (graft) for CABG has been shown to impact graft patency. The excellent early and late patency of in situ left internal thoracic artery (LITA) has stimulated the use of other arterial grafts, such as the radial artery (RA) and the right internal thoracic artery (RITA). However, target coronary vessels/lesions are limitations for the use of RITA and RA, and concerns regarding postoperative sternal wound infection with increases of early morbidity and mortality are reasons for limited use of bilateral ITA. The saphenous vein grafts (SVG), together with the left internal thoracic artery, are still the most commonly used conduits in CABG surgery.

Vein graft failure is associated with recurrence of angina and one of the primary reasons for reintervention, either by redo CABG or percutaneous coronary intervention (PCI). Early vein graft failure is not uncommon, and it was shown in the PREVENT IV multi-center trial6, that vein graft failure (occluded or stenosed) had occurred in 27% of all vein grafts at one year.

Despite this, SVG remains as an important conduit for most patients in contemporary bypass surgery and every effort should focus on promoting short and long-term patency of SVG. Previous studies by Souza have demonstrated that harvesting the SVG with a pedicle of surrounding tissue and without vein graft distension, the so-called "No touch" technique (NT), significantly improve patency compared with conventional technique i.e. stripping the vein of all adventitial tissue and distension prior to implantation. An international multi center randomized controlled clinical trial, (SUPERIOR SVG, NCT01047449) including 12 centers and 250 patients, was recently presented and showed favorable but not significant results for No touch vein grafts compared to conventional vein grafts. The protocol did not include cardiac computed tomography angiography (CCTA) for every patient which is an important difference compared to our planned study.

The major limitation regarding the putative benefit of NT technique of vein harvesting is that most of the data has all been derived from a single center. The surgical vein graft harvesting technique for NT grafts is more demanding. Therefore, there is a clear clinical equipoise to perform a multi-center randomized clinical trial to validate the excellent single-center results and determine whether the NT technique is reproducible, feasible and generalizable.

Conditions

Ischemic Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No touch

No touch technique. Patients are randomized to no touch vein harvesting. The technique is used as routine in Medical care by some hospitals.

Group Type: EXPERIMENTAL

No touch technique

Intervention Type: PROCEDURE

Veins for CABG is harvested with the no touch technique

Control

Control technique. Patients are randomized to Control vein harvesting. The technique is used as routine in Medical care.

Group Type: OTHER

Control technique

Intervention Type: PROCEDURE

Veins for CABG is harvested with the Control technique.

Interventions

No touch technique

Veins for CABG is harvested with the no touch technique

Intervention Type: PROCEDURE

Control technique

Veins for CABG is harvested with the Control technique.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• first time CABG patients
• age up to 80 years at the time for inclusion
• need for at least one vein graft
• able to provide informed consent and accepted for isolated primary non-emergent CABG.

Exclusion Criteria

• unable to use greater saphenous vein grafts (SVG) due to previous vein stripping or poor vein quality
• allergy to contrast dye
• renal failure with glomerular filtration rate (GFR)<15 ml/min
• coagulation disorders
• excessive risk of wound infection
• participation in other interventional trial on grafts
• any condition that seriously increases the risk of non-compliance or loss of follow-up

• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan James, Professor

Role: PRINCIPAL_INVESTIGATOR

Uppsala University Hospital

Locations

Aarhus

Aarhus, , Denmark

Göteborg

Gothenburg, , Sweden

Karlskrona

Karlskrona, , Sweden

Linköping

Linköping, , Sweden

Lund

Lund, , Sweden

Örebro, Sweden

Örebro, , Sweden

Karolinska Sjukhuset

Stockholm, , Sweden

Umeå

Umeå, , Sweden

Uppsala

Uppsala, , Sweden

Countries

Denmark; Sweden

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: RESULT

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Reference Type: DERIVED

PMID: 32272256 (View on PubMed)

Other Identifiers

U-2015-477

Identifier Type: -

Identifier Source: org_study_id