NCT00235846

Brief Summary

Conventional open vein harvesting from the legs during coronary artery bypass surgery result in wound complications among 30% of the patients. Endoscopic harvesting decrease the complication rate, but it remains to be shown whether this is also a fact among patient in whom only short segments of veingraft material is needed from the leg. We hypothesise that the rate of wound complications will be reduced and the patient satisfaction will be increased also among patients in whom only short vein segments are endoscopically harvested compared to conventional open vein harvesting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2004

Typical duration for not_applicable

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

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

Enrollment Period

2.6 years

First QC Date

October 10, 2005

Last Update Submit

April 13, 2015

Conditions

Coronary Arteriosclerosis

Keywords

Endoscopic vein harvestingSaphenous vein

Outcome Measures

Primary Outcomes (2)

  • Rate of wound complications

    30 days

  • Patient satisfaction

    30 days

Study Arms (2)

Conventional vein harvest

ACTIVE COMPARATOR

Conventional open vein harvest from the lower leg

Procedure: vein harvest

Endoscopic vein harvest

EXPERIMENTAL

Endoscopic vein harvest from the calf

Procedure: vein harvest

Interventions

vein harvestPROCEDURE

Conventional open vein harvest or endoscopic vein harvest

Conventional vein harvestEndoscopic vein harvest

Eligibility Criteria

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

You may qualify if:

  • Elective coronary artery bypass surgery

You may not qualify if:

  • Leg wounds
  • Acute surgery
  • Previous vascular surgery
  • Combined surgery (valve + coronary)
  • Arterial revascularization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg Hospital

Aalborg, DK-9100, Denmark

Location

Related Publications (1)

  • Andreasen JJ, Nekrasas V, Dethlefsen C. Endoscopic vs open saphenous vein harvest for coronary artery bypass grafting: a prospective randomized trial. Eur J Cardiothorac Surg. 2008 Aug;34(2):384-9. doi: 10.1016/j.ejcts.2008.04.028. Epub 2008 May 27.

    PMID: 18508277BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Jan J Andreasen, MD

    Department of Cardiothoracic Surgery, Aalborg hospital, Hobrovej, postboks 365, DK-9100 Aalborg, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 10, 2005

First Posted

October 12, 2005

Study Start

December 1, 2004

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

April 14, 2015

Record last verified: 2015-04

Locations

DK(1)