Coronary Artery DiseasePhase 4NCT00180388
VENEK: Healing in Different Vein Harvesting Methods During Aortocoronary Coronary Artery Bypass Graft Surgery (CABG)
A Phase 4 study testing endoscopic vein harvesting and open vein harvesting in people with Coronary Artery Disease, run by Boston Scientific Corporation at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- endoscopic vein harvesting and open vein harvesting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesGermany
- Study dates
- May 2004to Jun 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Varicose crural veins
- Emergency patients
- Combined operational procedures
- Preoperative complete immobilization
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Klinik Bad Gottleuba
Bad Gottleuba, D-01816
TU Dresden, Medizinische Fakultät Carl Gustav Carus, Klinik für Kardiochirurgie
Dresden, D - 01062
About this study
Official title: Comparison of Clinical and Economical Parameters of Healing in Different Vein Harvesting Methods During Aortocoronary CABG
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- endoscopic vein harvesting, open vein harvesting
- Keywords
- cardiovascular system, veins, saphenous vein
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic vein harvestingProcedure or surgery
open vein harvestingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic vein harvesting | Experimental | Harvesting of vein for coronary artery bypass grafting using endoscopy to visualize the vein Receives: Procedure: endoscopic vein harvesting |
| Open Vein harvesting | Active comparator | Harvesting of vein for coronary artery bypass grafting without endoscopy Receives: Procedure: open vein harvesting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the economic differences between methods of treatment
Follow-up until wound healing
Measured: up to 2 months
Secondary outcomes (1)
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
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionJun 2006
- Study completionJun 2006
Why it stopped: terminated for logistical reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Herzzentrum Dresden
- Responsible party
- Sponsor
- Investigators
- Matschke Knaut, MD, Principal investigator, TU Dresden, Medizinische Fakultät Carl Gustav Carus, Klinik für Kardiochirurgie, D - 01062 Dresden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180388
- Sponsor's protocol ID
- Version vom 30.01.2004
- Status last verified
- Mar 2007
- First submitted
- 12 Sep 2005
- Last updated
- 1 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical and Economical Parameters of Healing in Different Vein Harvesting Methods During Aortocoronary CABG
- ClinicalTrials.gov ID
- NCT00180388
- Acronym / sponsor ID
- Version vom 30.01.2004
- Conditions
- Coronary Artery Disease
- Keywords
- cardiovascular system, veins, saphenous vein
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated for logistical reasons
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Herzzentrum Dresden
- Study start
- May 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic vein harvesting | Experimental | Procedure: endoscopic vein harvestingHarvesting of vein for coronary artery bypass grafting using endoscopy to visualize the vein |
| Open Vein harvesting | Active comparator | Procedure: open vein harvestingHarvesting of vein for coronary artery bypass grafting without endoscopy |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Varicose crural veins
- Emergency patients
- Combined operational procedures
- Preoperative complete immobilization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic vein harvesting | Procedure or surgery | Endoscopic vein harvesting |
| open vein harvesting | Procedure or surgery | Open Vein harvesting |
Primary outcome
Evaluation of the economic differences between methods of treatment
Time frame: up to 2 months
Follow-up until wound healing
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: terminated for logistical reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matschke Knaut, MD principal investigator
TU Dresden, Medizinische Fakultät Carl Gustav Carus, Klinik für Kardiochirurgie, D - 01062 Dresden, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing endoscopic vein harvesting and open vein harvesting in people with Coronary Artery Disease, run by Boston Scientific Corporation at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: terminated for logistical reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the economic differences between methods of treatment (time frame: up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2016.