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

Phase 4

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Procedure: endoscopic vein harvesting; Procedure: open vein harvesting

• Registration Number: NCT00180388
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2007-03
• Last Update Submitted: 2016-08-31
• Last Update Posted: 2016-09-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopic vein harvesting	endoscopic vein harvesting	Harvesting of vein for coronary artery bypass grafting using endoscopy to visualize the vein
Open Vein harvesting	open vein harvesting	Harvesting of vein for coronary artery bypass grafting without endoscopy

Primary Outcome Measures

Name	Time	Method
Evaluation of the economic differences between methods of treatment	up to 2 months	Follow-up until wound healing

Secondary Outcome Measures

Name	Time	Method
Evaluation of the outcome in quality of life (questions according to the protocol) and rate of disorders in wound healing	up to 2 months	Follow-up until wound healing

Trial Locations

Locations (2)

Klinik Bad Gottleuba; 🇩🇪 Bad Gottleuba, Germany

TU Dresden, Medizinische Fakultät Carl Gustav Carus, Klinik für Kardiochirurgie; 🇩🇪 Dresden, Germany