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Ischemic Heart DiseaseSWEDEGRAFTNCT03501303

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

A study testing No touch technique in people with Ischemic Heart Disease, run by Uppsala University at 9 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 80 years
Conditions the study is for
Ischemic Heart Disease
What is being tested?
No touch technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
902 participants
Where
9 sitesin 2 countries
Study dates
20 Apr 2018to 17 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

Sweden8 sites

  • Göteborg

    Gothenburg

  • Karlskrona

    Karlskrona

  • Linköping

    Linköping

  • Lund

    Lund

  • Örebro, Sweden

    Örebro

  • Karolinska Sjukhuset

    Stockholm

  • Umeå

    Umeå

  • Uppsala

    Uppsala

Other trials in Sweden

Denmark1 site

  • Aarhus

    Aarhus

Other trials in Denmark

About this study

Official title: A Nordic, Multicentre, Prospective, Randomized, Register Based, Clinical Trial on No-touch Vein Graft (NT-graft) in Coronary Surgery

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.

Read the 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.

Being tested
No touch technique, Control technique
Medical subject headings
Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No touch techniqueProcedure or surgery

    Veins for CABG is harvested with the no touch technique

  • Control techniqueProcedure or surgery

    Veins for CABG is harvested with the Control technique.

Study groups in NCT03501303
Study groupRoleWhat they receive
No touchExperimentalNo touch technique. Patients are randomized to no touch vein harvesting. The technique is used as routine in Medical care by some hospitals.
Receives: Procedure: No touch technique
ControlOtherControl technique. Patients are randomized to Control vein harvesting. The technique is used as routine in Medical care.
Receives: Procedure: Control technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (6)

  1. Major adverse cardiac events (MACE) 1

    The frequency of incidence of all cause death

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

  2. MACE 2

    The frequency of myocardial infarction

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

  3. MACE 3

    The frequency of repeated revascularization

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

  4. Wound complications

    The frequency of incidence of postoperative leg wound complications from the harvesting site.

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

  5. Vein-graft stenosis

    The frequency of non-significant vein graft stenosis (20-50%)

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

  6. Perivascular inflammation

    Perivascular fat attenuation index (FAIPVAT) around right coronary artery, no-touch saphenous vein grafts, and left internal mammary artery grafts

    Measured: Follow-up period is from inclusion and surgery up to at least 2 years after.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2018
  2. Study start20 Apr 2018
  3. Primary completion19 Sep 2023
  4. Study completion17 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
In an online randomization module the randomization will be performed with permuted block randomization to 1:1 ratio.
Masking
None (open label)
Enrolment
902 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03501303
Sponsor's protocol ID
U-2015-477
Acronym
SWEDEGRAFT
Status last verified
Sep 2025
First submitted
14 Mar 2018
Last updated
10 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 3484393

  • 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.

    PubMed 15564545

  • 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.

    PubMed 10220677

  • 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.

    PubMed 8642821

  • 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.

    PubMed 16678585

  • 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.

    PubMed 16287955

  • 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.

    PubMed 11996262

  • 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.

    PubMed 16872965

  • 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.

    PubMed 16122459

  • 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.

    PubMed 19619776

  • 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.

    PubMed 26282605

  • 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.

    PubMed 39969129

  • Dalen M, Modrau IS, Jeppsson A, Dreifaldt M, Duvernoy O, Ericsson A, Friberg O, Holmgren A, El-Akkawi AI, Hultkvist H, Jensevik Eriksson K, Liden M, Nozohoor S, Ragnarsson S, Ternstrom L, Themudo R, Vikholm P, Thelin S, James S, Sartipy U. No-Touch vs Conventional Vein Grafts in Coronary Surgery: Seven-Year Clinical Outcomes of the SWEDEGRAFT Randomized Clinical Trial. JAMA Cardiol. 2026 Sep 30:e264222. doi: 10.1001/jamacardio.2026.4222. Online ahead of print.

    PubMed 42814420

  • Unosson H, Dalen M, Jensevik Eriksson K, Hultkvist H, James S, Jeppsson A, Kimose HH, Modrau IS, Ragnarsson S, Sartipy U, Thelin S, Vikholm P, Friberg O. Risk Factors for Leg Wound Infection After Conventional and No-Touch Vein Harvesting: Insights From a Multicentre Randomised Trial. Scand Cardiovasc J. 2026 Sep 7:1-23. doi: 10.1080/14017431.2026.2730710. Online ahead of print.

    PubMed 42704302

  • 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.

    PubMed 32272256

Questions about this trial

What is this clinical trial studying?

A study testing No touch technique in people with Ischemic Heart Disease, run by Uppsala University at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Sweden, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Saphenous vein grafts (SVGs) occluded/stenosed (time frame: Follow up period is from inclusion and surgery up to at least two years after.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03501303, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.

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