Autovenous Conduit for Coronary Artery Bypass GraftingPhase 4NCT02446522
Compare Endoscopic and Open Methods of Vein Harvesting for Coronary Artery Bypass Grafting
A Phase 4 study testing Open vein harvesting and Endoscopic vein harvesting in people with Autovenous Conduit for Coronary Artery Bypass Grafting, run by Meshalkin Research Institute of Pathology of Circulation.
Trial summary
There is no shared vision relating to integrity and quality of the conduit after the impact on the vein wall during vein harvesting. In this connection, the investigators studied the initial state of the venous conduit, interoperation damages of the vein and postoperative wound complications while using two methods of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Autovenous Conduit for Coronary Artery Bypass Grafting
- What is being tested?
- Open vein harvesting and Endoscopic vein harvesting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2012
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects with multivascular lesion of the coronary artery to whom coronary artery bypass surgery was indicated.
Who cannot join
- urgent coronary artery bypass surgery with unstable haemodynamics;
- previous coronary artery bypass surgery;
- chronic venous insufficiency С4-С6 under СЕAR classification;
- previous limb surgeries.
About this study
Official title: Comparative Results of Endoscopic and Open Methods of Vein Harvesting for Coronary Artery Bypass Grafting: a Prospective Randomized Parallel-group Trial.
There is no shared vision relating to integrity and quality of the conduit after the impact on the vein wall during vein harvesting. In this connection, the investigators studied the initial state of the venous conduit, interoperation damages of the vein and postoperative wound complications while using two methods of GSV harvesting.
Read the detailed description
The great saphenous vein (GSV) remains one of the most commonly used conduits due to its ease of harvest, availability and versatility [1] Traditional harvesting of GSV is open vein harvesting, which involves an extended leg incision. This technique is associated with a significant morbidity and wound complications occur in 2-24% of cases.
Minimally invasive techniques endoscopic vein harvesting (EVH), have therefore been developed to reduce post-CABG leg wound complications. Last time the endoscopic vein harvesting is the method of choice in many centers as it allowed reduction of post-surgical complications as compared to the open method. Although long-term graft patency following EVH has been questioned cohort studies have reported that the technique is safe and effective.
The possibility to use lymphoscintigraphy for evaluation of lower limb lymphatic system after vein harvesting for the coronary artery bypass surgeries was reported before. Nevertheless, the state of the lymphatic system after vein harvesting remains to be poorly studied.
Currently, there is no shared vision relating to integrity and quality of the conduit after the impact on the vein wall during vein harvesting. In this connection, the investigators studied the initial state of the venous conduit, interoperation damages of the vein and postoperative wound complications while using two methods of GSV harvesting.
- Being tested
- Open vein harvesting, Endoscopic vein harvesting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open vein harvestingProcedure or surgery
Open vein harvesting was performed as a continuous incision under vision control. The GSV was identified two fingers proximal to the medial malleolus according to the standard practice. The vein was harvested using Metzenbaum scissors, and a continuous incision was made along the route of the vein. Care was taken not to traumatize the nerve, vein or its branches. Vein branches were ligated with titanium clips. The wound was closed in layers with continuous 2-0 Polysorb sutures and 3-0 skin sutures.
Endoscopic vein harvestingProcedure or surgery
Endoscopic vein harvesting was performed through minimal incisions with use of Vasoview 6 system (Maquet Medical Systems, Wayne, NJ, USA.) The vein was identified through a 3 cm incision below the knee. The incision site was sealed using a balloon port to create a tunnel inside the leg. A second unit with cautery was inserted via the port to cut and seal the tributary branches. A 1 cm skin incision was made near the groin to ligate the distal end of the GSV and remove the vein, which was checked for leakage. The wound was closed with 3-0 skin sutures
| Study group | Role | What they receive |
|---|---|---|
| Open vein harvesting | Active comparator | Patients with IHD, who were underwent open vein harvest method (OVH) Receives: Procedure: Open vein harvesting |
| Endoscopic vein harvesting | Active comparator | Patients with IHD, who were underwent edoscopic vein harvestingopen vein harvest method (EVH). Receives: Procedure: Endoscopic vein harvesting |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative wound complications
all cases postoperative wound complications
Measured: during 30 day after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startJan 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autovenous Conduit for Coronary Artery Bypass GraftingStudies of the same condition, open and under way.
- 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
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02446522
- Sponsor's protocol ID
- EVH vs OVH
- Status last verified
- May 2015
- First submitted
- 13 May 2015
- Last updated
- 18 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Results of Endoscopic and Open Methods of Vein Harvesting for Coronary Artery Bypass Grafting: a Prospective Randomized Parallel-group Trial.
- ClinicalTrials.gov ID
- NCT02446522
- Acronym / sponsor ID
- EVH vs OVH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 May 2015 (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.
There is no shared vision relating to integrity and quality of the conduit after the impact on the vein wall during vein harvesting. In this connection, the investigators studied the initial state of the venous conduit, interoperation damages of the vein and postoperative wound complications while using two methods of GSV harvesting.
Detailed description
The great saphenous vein (GSV) remains one of the most commonly used conduits due to its ease of harvest, availability and versatility [1] Traditional harvesting of GSV is open vein harvesting, which involves an extended leg incision. This technique is associated with a significant morbidity and wound complications occur in 2-24% of cases.
Minimally invasive techniques endoscopic vein harvesting (EVH), have therefore been developed to reduce post-CABG leg wound complications. Last time the endoscopic vein harvesting is the method of choice in many centers as it allowed reduction of post-surgical complications as compared to the open method. Although long-term graft patency following EVH has been questioned cohort studies have reported that the technique is safe and effective.
The possibility to use lymphoscintigraphy for evaluation of lower limb lymphatic system after vein harvesting for the coronary artery bypass surgeries was reported before. Nevertheless, the state of the lymphatic system after vein harvesting remains to be poorly studied.
Currently, there is no shared vision relating to integrity and quality of the conduit after the impact on the vein wall during vein harvesting. In this connection, the investigators studied the initial state of the venous conduit, interoperation damages of the vein and postoperative wound complications while using two methods of GSV harvesting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open vein harvesting | Active comparator | Procedure: Open vein harvestingPatients with IHD, who were underwent open vein harvest method (OVH) |
| Endoscopic vein harvesting | Active comparator | Procedure: Endoscopic vein harvestingPatients with IHD, who were underwent edoscopic vein harvestingopen vein harvest method (EVH). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subjects with multivascular lesion of the coronary artery to whom coronary artery bypass surgery was indicated.
Key exclusion criteria (4 listed)
- urgent coronary artery bypass surgery with unstable haemodynamics;
- previous coronary artery bypass surgery;
- chronic venous insufficiency С4-С6 under СЕAR classification;
- previous limb surgeries.
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 |
|---|---|---|
| Open vein harvestingOpen vein harvesting was performed as a continuous incision under vision control. The GSV was identified two fingers proximal to the medial malleolus according to the standard practice. The vein was harvested using Metzenbaum scissors, and a continuous incision was made along the route of the vein. Care was taken not to traumatize the nerve, vein or its branches. Vein branches were ligated with titanium clips. The wound was closed in layers with continuous 2-0 Polysorb sutures and 3-0 skin sutures. | Procedure or surgery | Open vein harvesting |
| Endoscopic vein harvestingEndoscopic vein harvesting was performed through minimal incisions with use of Vasoview 6 system (Maquet Medical Systems, Wayne, NJ, USA.) The vein was identified through a 3 cm incision below the knee. The incision site was sealed using a balloon port to create a tunnel inside the leg. A second unit with cautery was inserted via the port to cut and seal the tributary branches. A 1 cm skin incision was made near the groin to ligate the distal end of the GSV and remove the vein, which was checked for leakage. The wound was closed with 3-0 skin sutures | Procedure or surgery | Endoscopic vein harvesting |
Primary outcome
postoperative wound complications
Time frame: during 30 day after operation
all cases postoperative wound complications
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 18 May 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Open vein harvesting and Endoscopic vein harvesting in people with Autovenous Conduit for Coronary Artery Bypass Grafting, run by Meshalkin Research Institute of Pathology of Circulation.
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 1 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: finished, as of the sponsor's last update on 18 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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 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?
postoperative wound complications (time frame: during 30 day after operation). 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 18 May 2015.