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

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
endoscopic vein harvesting
open vein harvesting
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring cardiovascular system, veins, saphenous vein

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinik Bad Gottleuba
  • TU Dresden, Medizinische Fakultät Carl Gustav Carus, Klinik für Kardiochirurgie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endoscopic vein harvesting

Open Vein harvesting

Arm Description

Harvesting of vein for coronary artery bypass grafting using endoscopy to visualize the vein

Harvesting of vein for coronary artery bypass grafting without endoscopy

Outcomes

Primary Outcome Measures

Evaluation of the economic differences between methods of treatment
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
Follow-up until wound healing

Full Information

First Posted
September 12, 2005
Last Updated
August 31, 2016
Sponsor
Boston Scientific Corporation
Collaborators
Herzzentrum Dresden
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1. Study Identification

Unique Protocol Identification Number
NCT00180388
Brief Title
VENEK: Healing in Different Vein Harvesting Methods During Aortocoronary Coronary Artery Bypass Graft Surgery (CABG)
Official Title
Comparison of Clinical and Economical Parameters of Healing in Different Vein Harvesting Methods During Aortocoronary CABG
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Terminated
Why Stopped
terminated for logistical reasons
Study Start Date
May 2004 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
Collaborators
Herzzentrum Dresden

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
cardiovascular system, veins, saphenous vein

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic vein harvesting
Arm Type
Experimental
Arm Description
Harvesting of vein for coronary artery bypass grafting using endoscopy to visualize the vein
Arm Title
Open Vein harvesting
Arm Type
Active Comparator
Arm Description
Harvesting of vein for coronary artery bypass grafting without endoscopy
Intervention Type
Procedure
Intervention Name(s)
endoscopic vein harvesting
Intervention Type
Procedure
Intervention Name(s)
open vein harvesting
Primary Outcome Measure Information:
Title
Evaluation of the economic differences between methods of treatment
Description
Follow-up until wound healing
Time Frame
up to 2 months
Secondary Outcome Measure Information:
Title
Evaluation of the outcome in quality of life (questions according to the protocol) and rate of disorders in wound healing
Description
Follow-up until wound healing
Time Frame
up to 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matschke Knaut, MD
Organizational Affiliation
TU Dresden, Medizinische Fakultät Carl Gustav Carus, Klinik für Kardiochirurgie, D - 01062 Dresden, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik Bad Gottleuba
City
Bad Gottleuba
ZIP/Postal Code
D-01816
Country
Germany
Facility Name
TU Dresden, Medizinische Fakultät Carl Gustav Carus, Klinik für Kardiochirurgie
City
Dresden
ZIP/Postal Code
D - 01062
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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