NCT03501303

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
902

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

April 20, 2018

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2023

Completed
Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

5.4 years

First QC Date

March 14, 2018

Last Update Submit

September 3, 2025

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Saphenous vein grafts (SVGs) occluded/stenosed

    The proportion of patients with graft failure defined as: SVGs occluded/stenosed \>50% on CCTA or has undergone percutaneous intervention to a vein graft or died within two years after CABG.

    Follow up period is from inclusion and surgery up to at least two years after.

Secondary Outcomes (6)

  • Major adverse cardiac events (MACE) 1

    Follow up period is from inclusion and surgery up to at least two years after.

  • MACE 2

    Follow up period is from inclusion and surgery up to at least two years after.

  • MACE 3

    Follow up period is from inclusion and surgery up to at least two years after.

  • Wound complications

    Follow up period is from inclusion and surgery up to at least two years after.

  • Vein-graft stenosis

    Follow up period is from inclusion and surgery up to at least two years after.

  • +1 more secondary outcomes

Other Outcomes (2)

  • Questions about wound healing

    At 3 months and 2 years after CABG surgery.

  • Questions about Quality of Life

    At 2 years after CABG surgery.

Study Arms (2)

No touch

EXPERIMENTAL

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

Procedure: No touch technique

Control

OTHER

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

Procedure: Control technique

Interventions

No touch techniquePROCEDURE

Veins for CABG is harvested with the no touch technique

No touch
Control techniquePROCEDURE

Veins for CABG is harvested with the Control technique.

Control

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Aarhus

Aarhus, Denmark

Location

Göteborg

Gothenburg, Sweden

Location

Karlskrona

Karlskrona, Sweden

Location

Linköping

Linköping, Sweden

Location

Lund

Lund, Sweden

Location

Örebro, Sweden

Örebro, Sweden

Location

Karolinska Sjukhuset

Stockholm, Sweden

Location

Umeå

Umeå, Sweden

Location

Uppsala

Uppsala, Sweden

Location

Related Publications (13)

  • Loop FD, Lytle BW, Cosgrove DM, Stewart RW, Goormastic M, Williams GW, Golding LA, Gill CC, Taylor PC, Sheldon WC, et al. Influence of the internal-mammary-artery graft on 10-year survival and other cardiac events. N Engl J Med. 1986 Jan 2;314(1):1-6. doi: 10.1056/NEJM198601023140101.

    PMID: 3484393BACKGROUND

  • Desai ND, Cohen EA, Naylor CD, Fremes SE; Radial Artery Patency Study Investigators. A randomized comparison of radial-artery and saphenous-vein coronary bypass grafts. N Engl J Med. 2004 Nov 25;351(22):2302-9. doi: 10.1056/NEJMoa040982.

    PMID: 15564545BACKGROUND

  • Lytle BW, Blackstone EH, Loop FD, Houghtaling PL, Arnold JH, Akhrass R, McCarthy PM, Cosgrove DM. Two internal thoracic artery grafts are better than one. J Thorac Cardiovasc Surg. 1999 May;117(5):855-72. doi: 10.1016/S0022-5223(99)70365-X.

    PMID: 10220677BACKGROUND

  • Parisian Mediastinitis Study Group. Risk factors for deep sternal wound infection after sternotomy: a prospective, multicenter study. J Thorac Cardiovasc Surg. 1996 Jun;111(6):1200-7. doi: 10.1016/s0022-5223(96)70222-2.

    PMID: 8642821BACKGROUND

  • Guru V, Fremes SE, Tu JV. How many arterial grafts are enough? A population-based study of midterm outcomes. J Thorac Cardiovasc Surg. 2006 May;131(5):1021-8. doi: 10.1016/j.jtcvs.2005.09.036. Epub 2006 Apr 25.

    PMID: 16678585BACKGROUND

  • Alexander JH, Hafley G, Harrington RA, Peterson ED, Ferguson TB Jr, Lorenz TJ, Goyal A, Gibson M, Mack MJ, Gennevois D, Califf RM, Kouchoukos NT; PREVENT IV Investigators. Efficacy and safety of edifoligide, an E2F transcription factor decoy, for prevention of vein graft failure following coronary artery bypass graft surgery: PREVENT IV: a randomized controlled trial. JAMA. 2005 Nov 16;294(19):2446-54. doi: 10.1001/jama.294.19.2446.

    PMID: 16287955BACKGROUND

  • Souza DS, Dashwood MR, Tsui JC, Filbey D, Bodin L, Johansson B, Borowiec J. Improved patency in vein grafts harvested with surrounding tissue: results of a randomized study using three harvesting techniques. Ann Thorac Surg. 2002 Apr;73(4):1189-95. doi: 10.1016/s0003-4975(02)03425-2.

    PMID: 11996262BACKGROUND

  • Souza DS, Johansson B, Bojo L, Karlsson R, Geijer H, Filbey D, Bodin L, Arbeus M, Dashwood MR. Harvesting the saphenous vein with surrounding tissue for CABG provides long-term graft patency comparable to the left internal thoracic artery: results of a randomized longitudinal trial. J Thorac Cardiovasc Surg. 2006 Aug;132(2):373-8. doi: 10.1016/j.jtcvs.2006.04.002.

    PMID: 16872965BACKGROUND

  • Dashwood MR, Savage K, Dooley A, Shi-Wen X, Abraham DJ, Souza DS. Effect of vein graft harvesting on endothelial nitric oxide synthase and nitric oxide production. Ann Thorac Surg. 2005 Sep;80(3):939-44. doi: 10.1016/j.athoracsur.2005.03.042.

    PMID: 16122459BACKGROUND

  • Dashwood MR, Savage K, Tsui JC, Dooley A, Shaw SG, Fernandez Alfonso MS, Bodin L, Souza DS. Retaining perivascular tissue of human saphenous vein grafts protects against surgical and distension-induced damage and preserves endothelial nitric oxide synthase and nitric oxide synthase activity. J Thorac Cardiovasc Surg. 2009 Aug;138(2):334-40. doi: 10.1016/j.jtcvs.2008.11.060. Epub 2009 Mar 10.

    PMID: 19619776BACKGROUND

  • Samano N, Geijer H, Liden M, Fremes S, Bodin L, Souza D. The no-touch saphenous vein for coronary artery bypass grafting maintains a patency, after 16 years, comparable to the left internal thoracic artery: A randomized trial. J Thorac Cardiovasc Surg. 2015 Oct;150(4):880-8. doi: 10.1016/j.jtcvs.2015.07.027. Epub 2015 Jul 15.

    PMID: 26282605BACKGROUND

  • Thelin S, Modrau IS, Duvernoy O, Dalen M, Dreifaldt M, Ericsson A, Friberg O, Holmgren A, Hostrup Nielsen P, Hultkvist H, Jensevik Eriksson K, Jeppsson A, Liden M, Nozohoor S, Ragnarsson S, Sartipy U, Ternstrom L, Themudo R, Vikholm P, James S. No-touch vein grafts in coronary artery bypass surgery: a registry-based randomized clinical trial. Eur Heart J. 2025 May 7;46(18):1720-1729. doi: 10.1093/eurheartj/ehaf018.

    PMID: 39969129RESULT

  • Ragnarsson S, Janiec M, Modrau IS, Dreifaldt M, Ericsson A, Holmgren A, Hultkvist H, Jeppsson A, Sartipy U, Ternstrom L, Per Vikholm MD, de Souza D, James S, Thelin S. No-touch saphenous vein grafts in coronary artery surgery (SWEDEGRAFT): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial. Am Heart J. 2020 Jun;224:17-24. doi: 10.1016/j.ahj.2020.03.009. Epub 2020 Mar 13.

    PMID: 32272256DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Stefan James, Professor

    Uppsala University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: In an online randomization module the randomization will be performed with permuted block randomization to 1:1 ratio.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2018

First Posted

April 18, 2018

Study Start

April 20, 2018

Primary Completion

September 19, 2023

Study Completion

November 17, 2023

Last Updated

September 10, 2025

Record last verified: 2025-09

Locations

DK(1)SE(8)