VENEK: Healing in Different Vein Harvesting Methods During Aortocoronary Coronary Artery Bypass Graft Surgery (CABG)

August 31, 2016 updated by: Boston Scientific Corporation

Comparison of Clinical and Economical Parameters of Healing in Different Vein Harvesting Methods During Aortocoronary CABG

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Gottleuba, Germany, D-01816
        • Klinik Bad Gottleuba
      • Dresden, Germany, D - 01062
        • TU Dresden, Medizinische Fakultät Carl Gustav Carus, Klinik für Kardiochirurgie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endoscopic vein harvesting
Harvesting of vein for coronary artery bypass grafting using endoscopy to visualize the vein
Procedure: endoscopic vein harvesting
Active Comparator: Open Vein harvesting
Harvesting of vein for coronary artery bypass grafting without endoscopy
Procedure: open vein harvesting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the economic differences between methods of treatment
Time Frame: up to 2 months
Follow-up until wound healing
up to 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the outcome in quality of life (questions according to the protocol) and rate of disorders in wound healing
Time Frame: up to 2 months
Follow-up until wound healing
up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Collaborators

Herzzentrum Dresden

Investigators

  • Principal Investigator: Matschke Knaut, MD, TU Dresden, Medizinische Fakultät Carl Gustav Carus, Klinik für Kardiochirurgie, D - 01062 Dresden, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

September 1, 2016

Last Update Submitted That Met QC Criteria

August 31, 2016

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version vom 30.01.2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe