NCT00180388

Brief Summary

The VENEK trial is a randomized, prospective trial to compare economic parameters, quality of life and wound healing after endoscopic vein harvesting versus open vein harvesting.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
Completed

Started May 2004

Geographic Reach
1 country

2 active sites

Status
terminated

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

May 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

September 1, 2016

Status Verified

March 1, 2007

Enrollment Period

2.1 years

First QC Date

September 12, 2005

Last Update Submit

August 31, 2016

Conditions

Coronary Artery Disease

Keywords

cardiovascular systemveinssaphenous vein

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the economic differences between methods of treatment

    Follow-up until wound healing

    up to 2 months

Secondary Outcomes (1)

  • Evaluation of the outcome in quality of life (questions according to the protocol) and rate of disorders in wound healing

    up to 2 months

Study Arms (2)

Endoscopic vein harvesting

EXPERIMENTAL

Harvesting of vein for coronary artery bypass grafting using endoscopy to visualize the vein

Procedure: endoscopic vein harvesting

Open Vein harvesting

ACTIVE COMPARATOR

Harvesting of vein for coronary artery bypass grafting without endoscopy

Procedure: open vein harvesting

Interventions

endoscopic vein harvestingPROCEDURE
Endoscopic vein harvesting
open vein harvestingPROCEDURE
Open Vein harvesting

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 60 years
  • Admission at Herzzentrum Dresden - Herzchirurgie for bypass-operation (OP) with planned veinectomy
  • Eligibility for different modes of planned intervention according to study protocol
  • Signed patient informed consent

You may not qualify if:

  • Varicose crural veins
  • Emergency patients
  • Combined operational procedures
  • Preoperative complete immobilization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Klinik Bad Gottleuba

Bad Gottleuba, D-01816, Germany

Location

TU Dresden, Medizinische Fakultät Carl Gustav Carus, Klinik für Kardiochirurgie

Dresden, D - 01062, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Matschke Knaut, MD

    TU Dresden, Medizinische Fakultät Carl Gustav Carus, Klinik für Kardiochirurgie, D - 01062 Dresden, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

May 1, 2004

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

September 1, 2016

Record last verified: 2007-03

Locations

DE(2)