NCT01834846

Brief Summary

The success of coronary artery bypass grafting is reliant on the quality of the grafts used. A new technique for harvesting veins used as grafts has been introduced. The study hypothesis is that veins harvested with this technique have an improved endothelial function.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2013

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

3.6 years

First QC Date

April 15, 2013

Last Update Submit

December 31, 2020

Conditions

Myocardial Ischemia

Keywords

comparative studyCardiac Surgical Procedures

Outcome Measures

Primary Outcomes (2)

  • Graft function

    Graft function as evaluated by coronary angiography in the first 60 out of 100 patients

    6 months

  • Graft function

    Graft function as evaluated by coronary angiography in all 100 patients

    5 years

Secondary Outcomes (5)

  • Morphological appearance of vein graft

    6 months

  • Morphological appearance of vein graft

    5 years

  • Postoperative leg wound complications

    6 weeks

  • Postoperative complications related to cardiac surgery

    Discharge, 6 weeks, 6 months

  • Postoperative complications related to cardiac surgery

    5 years

Study Arms (2)

no-touch

EXPERIMENTAL

no-touch technique of harvesting the saphenous vein graft for coronary artery bypass grafting

Procedure: no-touch

conventional

ACTIVE COMPARATOR

conventional technique of harvesting the saphenous vein graft for coronary artery bypass grafting

Procedure: conventional

Interventions

no-touchPROCEDURE

The saphenous vein is exposed by a longitudinal incision, and all visible side branches ligated. The vein is then isolated together with a pedicle of surrounding tissue and manually distended and stored in a combination of blood and saline using a syringe, according to standard procedure at St. Olav's Hospital.

no-touch
conventionalPROCEDURE

The saphenous vein is exposed by a longitudinal leg incision, skeletonized from surrounding tissue, and side branches ligated. The vein is removed from the leg immediately after dissection, manually distended and stored in a combination of blood and saline using a syringe, according to standard procedure at St. Olav's Hospital.

conventional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Isolated elective, primary CABG requiring cardiopulmonary bypass
  • Left ventricular ejection fraction \>35%
  • at least one saphenous vein graft required as part of revascularization strategy

You may not qualify if:

  • Acute or chronic inflammatory diseases
  • Malignancies
  • Pregnancy
  • Previous cardiac surgery
  • Serum creatinine \>120 μmol/L
  • Coagulopathy
  • Insulin dependent diabetes mellitus
  • Smoking during last 6 months
  • Leg not suitable for No-touch vein harvesting as judged by the operator.
  • Need for nitrates on operation day
  • not receiving statins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Circulation and Imaging

Trondheim, Sør-Trøndelag, 7042, Norway

Location

Related Publications (3)

  • Pettersen O, Wiseth R, Hegbom K, Nordhaug DO. Pedicled Vein Grafts in Coronary Surgery Exhibit Reduced Intimal Hyperplasia at 6 Months. J Am Coll Cardiol. 2016 Jul 26;68(4):427-9. doi: 10.1016/j.jacc.2016.04.058. No abstract available.

    PMID: 27443441RESULT

  • Pettersen O, Haram PM, Winnerkvist A, Karevold A, Wahba A, Stenvik M, Wiseth R, Hegbom K, Nordhaug DO. Pedicled Vein Grafts in Coronary Surgery: Perioperative Data From a Randomized Trial. Ann Thorac Surg. 2017 Oct;104(4):1313-1317. doi: 10.1016/j.athoracsur.2017.03.076. Epub 2017 Jun 23.

    PMID: 28648540RESULT

  • Pettersen O, Pociask E, Malinowski KP, Slezak M, Hegbom K, Wiseth R, Nordhaug DO. Reproducibility of optical coherence tomography in vein grafts used for coronary revascularization. Cardiol J. 2020;27(5):518-523. doi: 10.5603/CJ.a2018.0139. Epub 2018 Nov 16.

    PMID: 30444258DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Dag Ole Nordhaug, md phd

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2013

First Posted

April 18, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2021

Last Updated

January 5, 2021

Record last verified: 2020-12

Locations

NO(1)