Long-term Results Following Endoscopic Vein Harvesting in Coronary Artery Bypass Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01480726
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : April 14, 2015
Aalborg University
Information provided by (Responsible Party):
Jan Jesper Andreasen, MD, PhD, Aalborg Universitetshospital

Brief Summary:

Vena saphena magna is still frequently used as graft material in coronary artery bypass grating(CABG, and vein grafts can harvest with either the conventional open technique (Ovh = open vein harvesting), or with less invasive endoscopic techniques (EVH = Endoscopic vein harvesting). The endoscopic techniques have been shown to reduce the incidence of postoperative wound complications while patients are more satisfied with the cosmetic result of the operation on the leg.

Non-randomized studies have raised doubts about patency rates of the vein grafts following EVH compared to OVH, while other studies failed to detect any problems in relation to this. There are only very few data on long-term patency rates from randomized studies.

The purpose of this study is to investigate clinical outcome and patency rates of the vein grafts following either EVH and OVH in 132 patients who underwent CABG for 4-7 years ago as part of a randomized study investigation wound complications. A cost-effectiveness analysis will also be performed.

The hypothesis is: Patency rates following EVH are worse compared to OVH in CABG 4-7 years postoperatively.

Condition or disease Intervention/treatment
Angina Pectoris Procedure: Surgery

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 132 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endoscopic Versus Open Vein Harvest in Coronary Artery Bypass Grafting. Clinical and CT-angiographic Long-term Result From a Randomized Study.
Study Start Date : November 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Open vein harvest
Conventional open vein harvest from the lower leg
Procedure: Surgery
Endoscopic vein harvest
Endoscopic vein harvest from the calf
Procedure: Surgery

Primary Outcome Measures :
  1. Patency rates of vein grafts [ Time Frame: 5-7 years postoperatively ]

Secondary Outcome Measures :
  1. recurrence of angina pectoris [ Time Frame: 5-7 years postoperatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   43 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A total of 132 patients who underwent CABG 4-7 years ago. All patients participated in a randomized study focusing on wound complications from the leg following either open or endoscopic vein harvest.

Inclusion Criteria:

  • Patients who participated in the previous randomized study
  • Informed consent from the patient

Exclusion Criteria:

  • Survival until date of reexamination
  • No informed consent
  • CT scan of the heart will not be performed in patients with if: atrial fibrillation,p-creatinin >120 micromol/l, allergy to contrast, pregnancy, lactating.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01480726

Aalborg University Hospital
Aalborg, Denmark, 9100
Sponsors and Collaborators
Aalborg Universitetshospital
Aalborg University
Principal Investigator: Jan J. Andreasen, MD. PhD Aalborg Universitetshospital

Responsible Party: Jan Jesper Andreasen, MD, PhD, Professor, MD, PhD, Aalborg Universitetshospital Identifier: NCT01480726     History of Changes
Other Study ID Numbers: N20110023
First Posted: November 29, 2011    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: November 2011

Additional relevant MeSH terms:
Angina Pectoris
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms