Triple Vessel DiseaseCOSAVEGUL-1NCT01974492
Comparison of Saphenous Vein Graft Harvested From Upper Versus Lower Leg in Coronary Artery Bypass Grafting
A study testing Upper leg vein harvesting and Lower leg vein harvesting in people with Triple Vessel Disease and Unstable Angina, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In coronary artery bypass grafting, saphenous veins are widely used as a composite grafts that are Y-anastomosed to in-situ left internal thoracic artery. Based on our observation that remodeling of saphenous vein graft differs between those harvested from upper leg vein and lower leg, this study aims to compare… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Triple Vessel Disease, Unstable Angina, Stable Angina
- What is being tested?
- Upper leg vein harvesting and Lower leg vein harvesting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Jun 2016
- Phase
- Interventional
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with multivessel disease who were planned to undergo off-pump coronary artery bypass grafting
- Patients whose left internal thoracic arteries can be used, and whose saphenous vein grafts will be Y-anastomosed to left internal thoracic arteries.
- Patients whose saphenous vein grafts can be harvested from both upper and lower legs.
Who cannot join
- Patients with overt heart failure symptoms
- Patients with intractable ventricular arrhythmia
- Patients with history of cancer or malignancy
- Patients with coagulation or other hematologic disorder
- Patients who needs concomitant cardiac procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Histologic and Immunohistochemical Characteristics Between the Upper and Lower Leg Saphenous Veins Used for Coronary Artery Bypass Grafting
In coronary artery bypass grafting, saphenous veins are widely used as a composite grafts that are Y-anastomosed to in-situ left internal thoracic artery. Based on our observation that remodeling of saphenous vein graft differs between those harvested from upper leg vein and lower leg, this study aims to compare histologic and immunohistochemical findings between saphenous vein grafts harvested from upper leg and lower leg.
Read the detailed description
Inclusion criteria:
- Patients aged from 40 to 75 years with triple vessel disease
- Patients who are eligible for the use of left internal thoracic artery as an in situ primary conduit
- Operation plan: saphenous vein graft will be Y-anastomosed to left internal thoracic artery.
- Patients whose saphenous vein grafts can be harvested from both upper legs and lower legs
- Patients who are eligible for off-pump coronary artery bypass grafting
- Patients who agreed with the participation in the research based on thorough explanation.
Patients will be randomly assigned to upper leg vein (ULV) group and lower leg vein (LLV) group immediately after anesthetic induction.
Pieces of residual saphenous vein graft will be sent for histologic and immunohistochemical examination for the evaluation of endothelial cell preservation and the expression of matrix proteins.
- Being tested
- Upper leg vein harvesting, Lower leg vein harvesting
- Keywords
- saphenous vein graft, composite graft, coronary artery bypass grafting, graft remodeling
- Medical subject headings
- Angina, Unstable, Angina, Stable, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper leg vein harvestingProcedure or surgery
Patients whose saphenous veins are harvested from upper legs.
Lower leg vein harvestingProcedure or surgery
Patients whose saphenous veins are harvested from lower legs.
| Study group | Role | What they receive |
|---|---|---|
| Upper leg vein | Active comparator | Upper leg vein harvesting Receives: Procedure: Upper leg vein harvesting |
| Lower leg vein | Active comparator | Lower leg vein harvesting Receives: Procedure: Lower leg vein harvesting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial preservation of saphenous vein graft
Participants will be followed for the duration of hospital stay, an expected average of 1 week.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Vessel DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki-Bong Kim, Seoul National University Hospital
- Investigators
- Ki-Bong Kim, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974492
- Sponsor's protocol ID
- SNUHTS_KBKim_Saphenous
- Acronym
- COSAVEGUL-1
- Status last verified
- Jun 2016
- First submitted
- 26 Oct 2013
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Histologic and Immunohistochemical Characteristics Between the Upper and Lower Leg Saphenous Veins Used for Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT01974492
- Acronym / sponsor ID
- COSAVEGUL-1 / SNUHTS_KBKim_Saphenous
- Keywords
- saphenous vein graft, composite graft, coronary artery bypass grafting, graft remodeling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 1 Nov 2013 (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.
In coronary artery bypass grafting, saphenous veins are widely used as a composite grafts that are Y-anastomosed to in-situ left internal thoracic artery. Based on our observation that remodeling of saphenous vein graft differs between those harvested from upper leg vein and lower leg, this study aims to compare histologic and immunohistochemical findings between saphenous vein grafts harvested from upper leg and lower leg.
Detailed description
Inclusion criteria:
- Patients aged from 40 to 75 years with triple vessel disease
- Patients who are eligible for the use of left internal thoracic artery as an in situ primary conduit
- Operation plan: saphenous vein graft will be Y-anastomosed to left internal thoracic artery.
- Patients whose saphenous vein grafts can be harvested from both upper legs and lower legs
- Patients who are eligible for off-pump coronary artery bypass grafting
- Patients who agreed with the participation in the research based on thorough explanation.
Patients will be randomly assigned to upper leg vein (ULV) group and lower leg vein (LLV) group immediately after anesthetic induction.
Pieces of residual saphenous vein graft will be sent for histologic and immunohistochemical examination for the evaluation of endothelial cell preservation and the expression of matrix proteins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upper leg vein | Active comparator | Procedure: Upper leg vein harvestingUpper leg vein harvesting |
| Lower leg vein | Active comparator | Procedure: Lower leg vein harvestingLower leg vein harvesting |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with multivessel disease who were planned to undergo off-pump coronary artery bypass grafting
- Patients whose left internal thoracic arteries can be used, and whose saphenous vein grafts will be Y-anastomosed to left internal thoracic arteries.
- Patients whose saphenous vein grafts can be harvested from both upper and lower legs.
Key exclusion criteria (5 listed)
- Patients with overt heart failure symptoms
- Patients with intractable ventricular arrhythmia
- Patients with history of cancer or malignancy
- Patients with coagulation or other hematologic disorder
- Patients who needs concomitant cardiac procedures
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 |
|---|---|---|
| Upper leg vein harvestingPatients whose saphenous veins are harvested from upper legs. | Procedure or surgery | Upper leg vein |
| Lower leg vein harvestingPatients whose saphenous veins are harvested from lower legs. | Procedure or surgery | Lower leg vein |
Primary outcome
Endothelial preservation of saphenous vein graft
Time frame: 1 year
Participants will be followed for the duration of hospital stay, an expected average of 1 week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 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.
Ki-Bong Kim, M.D., Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper leg vein harvesting and Lower leg vein harvesting in people with Triple Vessel Disease and Unstable Angina, run by Seoul National University Hospital at 1 site in South Korea.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 4 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Endothelial preservation of saphenous vein graft (time frame: 1 year). 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 4 Jul 2016.