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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:
Collaborator:
Herzzentrum Dresden
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00180388
First received: September 12, 2005
Last updated: August 31, 2016
Last verified: March 2007
  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:


Further study details as provided by Boston Scientific Corporation:

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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 300
Study Start Date: May 2004
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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   (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
  More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00180388     History of Changes
Other Study ID Numbers: Version vom 30.01.2004
Study First Received: September 12, 2005
Last Updated: August 31, 2016

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

ClinicalTrials.gov processed this record on March 29, 2017