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

This study has been terminated.
(terminated for logistical reasons)
Sponsor:
Information provided by:
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00180388
First received: September 12, 2005
Last updated: March 9, 2007
Last verified: March 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
 Procedure: endoscopic vein harvesting
Procedure: open vein harvesting
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Clinical and Economical Parameters of Healing in Different Vein Harvesting Methods During Aortocoronary CABG

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Guidant Corporation:

Primary Outcome Measures:
  • Evaluation of the economic differences between methods of treatment

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

Estimated Enrollment: 300
Study Start Date: May 2004
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00180388

Locations
Germany
Klinik Bad Gottleuba
Bad Gottleuba, Germany, D-01816
TU Dresden, Medizinische Fakultät Carl Gustav Carus, Klinik für Kardiochirurgie
Dresden, Germany, D - 01062
Sponsors and Collaborators
Guidant Corporation
Investigators
Principal Investigator: Matschke Knaut, MD TU Dresden, Medizinische Fakultät Carl Gustav Carus, Klinik für Kardiochirurgie, D - 01062 Dresden, Germany
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00180388     History of Changes
Other Study ID Numbers: Version vom 30.01.2004
Study First Received: September 12, 2005
Last Updated: March 9, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Guidant Corporation:
cardiovascular system
veins
saphenous vein

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013