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

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ClinicalTrials.gov Identifier: NCT00180388
Recruitment Status : Terminated (terminated for logistical reasons)
First Posted : September 16, 2005
Last Update Posted : September 1, 2016
Sponsor:
Collaborator:
Herzzentrum Dresden
Information provided by (Responsible Party):
Boston Scientific Corporation

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: endoscopic vein harvesting Procedure: open vein harvesting Phase 4

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  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Clinical and Economical Parameters of Healing in Different Vein Harvesting Methods During Aortocoronary CABG
Study Start Date : May 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Evaluation of the economic differences between methods of treatment [ Time Frame: up to 2 months ]
    Follow-up until wound healing


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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
Boston Scientific Corporation
Herzzentrum Dresden
Investigators
Principal Investigator: Matschke Knaut, MD TU Dresden, Medizinische Fakultät Carl Gustav Carus, Klinik für Kardiochirurgie, D - 01062 Dresden, Germany

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00180388     History of Changes
Other Study ID Numbers: Version vom 30.01.2004
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: March 2007

Keywords provided by Boston Scientific 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