NCT01686100

Brief Summary

Coronary artery surgery (CABG) is necessary to improve blood circulation in many patients with coronary artery disease. This is done by using alternative blood vessels (grafts) to bypass the stenosed coronary arteries. In CABG, vein grafts are traditionally used where surrounding tissue is removed, this may damage the vessel and influence its patency. The "no-touch" technique was developed by Professor Domingos Souza at the Department of Cardiovascular and Thoracic Surgery, Örebro University Hospital. This technique includes taking out the vein with its surrounding tissue and by this way the vessel is less damaged. The first two follow ups have shown that no-touch grafts had better patency than conventionally extracted graft at 18 months and 8.5 years. This long term follow up is a continuation of the randomized trial started in 1993 where the patency and incidence of stenoses in the no touch and conventional vein grafts has been studied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jun 2010

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

June 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 17, 2012

Completed
Last Updated

September 19, 2012

Status Verified

September 1, 2012

Enrollment Period

1.4 years

First QC Date

September 12, 2012

Last Update Submit

September 18, 2012

Conditions

Coronary Artery Disease

Keywords

Coronary artery bypass graftingSaphenous vein grafts

Outcome Measures

Primary Outcomes (1)

  • Patency of the grafts

    Mean time of 15 years.

Secondary Outcomes (1)

  • Stenosis in the grafts.

    Mean time of 15 years.

Study Arms (2)

No touch vein grafts

ACTIVE COMPARATOR

The grafts were harvested with there surrounding tissues.

Procedure: No touch technique

Conventional vein grafts.

ACTIVE COMPARATOR

The grafts were stripped from surrounding tissue.

Procedure: Conventional technique

Interventions

No touch techniquePROCEDURE

The vein graft is harvested with its surronding tissues.

No touch vein grafts
Conventional techniquePROCEDURE

The vein graft is stripped from its surrounding tissues.

Conventional vein grafts.

Eligibility Criteria

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

You may qualify if:

  • First time coronary artery bypass grafting with either conventional or no touch vein grafts performed by Dr.Souza between 1993-1997.
  • Included in the previous follow up studies
  • Signed and dated consent.

You may not qualify if:

  • Allergy to contrast
  • Renal failure
  • Uncontrolled diabetes
  • Unable to implement the study according to protocol -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for Cardiovascular and Thoracic Surgery, Örebro University Hospital

Örebro, 70185, Sweden

Location

Related Publications (16)

  • 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

  • Loesch A, Dashwood MR, Souza DS. Does the method of harvesting the saphenous vein for coronary artery bypass surgery affect venous smooth muscle cells? iNOS immunolabelling and ultrastructural findings. Int J Surg. 2006;4(1):20-9. doi: 10.1016/j.ijsu.2005.11.002. Epub 2006 Jan 3.

    PMID: 17462310BACKGROUND

  • Dashwood MR, Dooley A, Shi-Wen X, Abraham DJ, Dreifaldt M, Souza DS. Perivascular fat-derived leptin: a potential role in improved vein graft performance in coronary artery bypass surgery. Interact Cardiovasc Thorac Surg. 2011 Feb;12(2):170-3. doi: 10.1510/icvts.2010.247874. Epub 2010 Nov 3.

    PMID: 21051379BACKGROUND

  • Dreifaldt M, Souza DS, Loesch A, Muddle JR, Karlsson MG, Filbey D, Bodin L, Norgren L, Dashwood MR. The "no-touch" harvesting technique for vein grafts in coronary artery bypass surgery preserves an intact vasa vasorum. J Thorac Cardiovasc Surg. 2011 Jan;141(1):145-50. doi: 10.1016/j.jtcvs.2010.02.005. Epub 2010 Apr 9.

    PMID: 20381817BACKGROUND

  • Johansson BL, Souza DS, Bodin L, Filbey D, Loesch A, Geijer H, Bojo L. Slower progression of atherosclerosis in vein grafts harvested with 'no touch' technique compared with conventional harvesting technique in coronary artery bypass grafting: an angiographic and intravascular ultrasound study. Eur J Cardiothorac Surg. 2010 Oct;38(4):414-9. doi: 10.1016/j.ejcts.2010.02.007. Epub 2010 Apr 1.

    PMID: 20362457BACKGROUND

  • Johansson BL, Souza DS, Bodin L, Filbey D, Bojo L. No touch vein harvesting technique for CABG improves the long-term clinical outcome. Scand Cardiovasc J. 2009 Feb;43(1):63-8. doi: 10.1080/14017430802140104.

    PMID: 18609044BACKGROUND

  • Rueda Fd, Souza D, Lima Rde C, Menezes A, Johansson B, Dashwood M, The E, Gesteira M, Escobar M, Vasconcelos F. Novel no-touch technique of harvesting the saphenous vein for coronary artery bypass grafting. Arq Bras Cardiol. 2008 Jun;90(6):356-62. doi: 10.1590/s0066-782x2008000600002. English, Portuguese.

    PMID: 18592087BACKGROUND

  • 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 M, Anand R, Loesch A, Souza D. Surgical trauma and vein graft failure: further evidence for a role of ET-1 in graft occlusion. J Cardiovasc Pharmacol. 2004 Nov;44 Suppl 1:S16-9. doi: 10.1097/01.fjc.0000166222.50346.c6.

    PMID: 15838269BACKGROUND

  • 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

  • Tsui JC, Souza DS, Filbey D, Karlsson MG, Dashwood MR. Localization of nitric oxide synthase in saphenous vein grafts harvested with a novel "no-touch" technique: potential role of nitric oxide contribution to improved early graft patency rates. J Vasc Surg. 2002 Feb;35(2):356-62. doi: 10.1067/mva.2002.121072.

    PMID: 11854735BACKGROUND

  • Tsui JC, Souza DS, Filbey D, Bomfim V, Dashwood MR. Preserved endothelial integrity and nitric oxide synthase in saphenous vein grafts harvested by a 'no-touch' technique. Br J Surg. 2001 Sep;88(9):1209-15. doi: 10.1046/j.0007-1323.2001.01855.x.

    PMID: 11531869BACKGROUND

  • Souza DS, Christofferson RH, Bomfim V, Filbey D. "No-touch" technique using saphenous vein harvested with its surrounding tissue for coronary artery bypass grafting maintains an intact endothelium. Scand Cardiovasc J. 1999;33(6):323-9. doi: 10.1080/14017439950141362.

    PMID: 10622542BACKGROUND

  • Souza D. A new no-touch preparation technique. Technical notes. Scand J Thorac Cardiovasc Surg. 1996;30(1):41-4. doi: 10.3109/14017439609107239. No abstract available.

    PMID: 8727856BACKGROUND

  • 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: 26282605DERIVED

  • Johansson B, Samano N, Souza D, Bodin L, Filbey D, Mannion JD, Bojo L. The no-touch vein graft for coronary artery bypass surgery preserves the left ventricular ejection fraction at 16 years postoperatively: long-term data from a longitudinal randomised trial. Open Heart. 2015 Mar 24;2(1):e000204. doi: 10.1136/openhrt-2014-000204. eCollection 2015.

    PMID: 25852948DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 12, 2012

First Posted

September 17, 2012

Study Start

June 1, 2010

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

September 19, 2012

Record last verified: 2012-09

Locations

SE(1)