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NCT00180388 Clinical Trial

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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00180388
Other study ID # Version vom 30.01.2004
Secondary ID
Status Terminated
Phase Phase 4
First received September 12, 2005
Last updated August 31, 2016
Start date May 2004
Est. completion date June 2006

Study information
Verified date March 2007
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 300
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender Both
Age group 60 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• endoscopic vein harvesting

• open vein harvesting

Locations
Country Name City State
Germany Klinik Bad Gottleuba Bad Gottleuba
Germany TU Dresden, Medizinische Fakultät Carl Gustav Carus, Klinik für Kardiochirurgie Dresden

Sponsors (2)
Lead Sponsor Collaborator
Boston Scientific Corporation Herzzentrum Dresden

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of the economic differences between methods of treatment Follow-up until wound healing up to 2 months No
Secondary Evaluation of the outcome in quality of life (questions according to the protocol) and rate of disorders in wound healing Follow-up until wound healing up to 2 months No
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