Coronary Artery Bypass Grafting SurgeryPhase 4ESOSNCT01121341
ESOS (Endoscopic Saphenous Harvesting With an Open CO2 System) Trial
A Phase 4 study testing Vein harvesting in people with Coronary Artery Bypass Grafting Surgery, run by Azienda Ospedaliera San Giovanni Battista at 1 site in Italy.
Trial summary
The ESOS (Endoscopic Saphenous harvesting with an Open CO2 System) trial is a prospective randomized trial for coronary artery bypass grafting (CABG) surgery to compare endoscopic open CO2 harvesting system versus conventional vein harvesting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Grafting Surgery
- What is being tested?
- Vein harvesting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- May 2010to Jun 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective planned CABG surgery
- First isolated CABG surgery
Who cannot join
- Emergency revascularization: patients with hemodynamic instability or requiring inotropic or intra-aortic balloon support
- Previous cardiac surgery
- Planned concomitant valve surgery
- Very varicous veins
- Previous saphenectomy
- History of deep vein thrombosis
Show all 10Show fewer
- History of suffered trauma on the lower extremity
- Preoperative legs immobilization
- Previous leg wound complications
- Coexisting illness with life expectancy < five years
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria San Giovanni Battista di Torino
Turin, Piedmont, 10126
Antonio Campanella, MD, +39 011 633 55 11, antoniocampanella@libero.it
Antonio Campanella, MD
About this study
Official title: ESOS (Endoscopic Saphenous Harvesting With an Open CO2 System) Trial: a Prospective Randomized Trial for Coronary Artery Bypass Grafting (CABG) Surgery.
The ESOS (Endoscopic Saphenous harvesting with an Open CO2 System) trial is a prospective randomized trial for coronary artery bypass grafting (CABG) surgery to compare endoscopic open CO2 harvesting system versus conventional vein harvesting.
Read the detailed description
The ESOS (Endoscopic Saphenous harvesting with an Open CO2 System) trial is a prospective randomized trial for coronary artery bypass grafting (CABG) surgery to compare and to test improvement in wound healing, quality of life, safety/efficacy, cost-effectiveness, short and long-term outcomes and vein-graft patency after endoscopic open CO2 harvesting system versus conventional vein harvesting.
- Conditions
- Coronary Artery Bypass Grafting Surgery
- Being tested
- Vein harvesting
- Keywords
- Endoscopic vein harvesting, Saphenous vein, Conventional vein harvesting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vein harvestingProcedure or surgery
Endoscopic versus conventional vein harvesting
| Study group | Role | What they receive |
|---|---|---|
| EVOH | Experimental | Procedure: Endoscopic vein with an open CO2 system harvesting Receives: Procedure: Vein harvesting |
| OVH | Active comparator | Procedure: Conventional vein harvesting Receives: Procedure: Vein harvesting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity hypothesis
When compared to Conventional vein-graft harvesting (CVH) in CABG surgery
- Does Endoscopic vein-graft open CO2 system harvesting (EVOH) reduce postoperative wound complications (composite endpoint of all complications or individual complications) assessed with ASEPSIS score?
Measured: six weeks
Patient satisfaction hypothesis
- Does EVOH improve patient satisfaction, postoperative leg pain and quality of life assessed with VAS score and EUROQol-5D?
- To compare health-related quality of life for the two treatment arms (EVOH/CVH) by intention-to-treat
- To identify factors in addition to treatment assignment that are associated with variations in quality of life outcomes
Measured: six weeks
Resource utilization hypothesis
When compared to Conventional vein-graft harvesting (CVH) in CABG surgery
- Does EVOH affect resource utilization?
- Harvesting time related to the length of vein segments
- Harvesting closure time
- CABG time
- Mobility time
- Hospital length of stay
- Re-exploration for bleeding due to vein-graft bleed
- Readmission for leg wound complications
- Need for outpatient wound management resources
- To compare total medical costs for the two treatment arms (EVOH/CVH) by intention-to-treat
Measured: six weeks
Quality of vein harvesting hypothesis
When compared to Conventional vein-graft harvesting (CVH) in CABG surgery
- Do EVOH compromises the quality of venous conduit harvested?
- Number of harvested veins requiring repair
- Number of repairs to each vein
- Re-exploration for bleeding due to vein-graft bleed
- Histological integrity
- Specific secondary subanalysis adjusted for:
- Preparation solution of the vein conduit
- 20 ml autologous blood
- 0,5 ml heparin (5000UI/ml) = 2500 UI
- 2 ml papavarine (30mg/ml) = 60 mg
- Uncontrolled distension pressure/ no touch technique harvesting
Measured: six weeks
Secondary outcomes (2)
Vein-graft patency hypothesis
Does EVH Open-CO2 system influence and improve vein-graft patency?
- Assessment of systemic carbon dioxide absorption with respiratory and hemodynamic parameters
- Assessment of vein-graft patency with:
- vein conduit quality [diameter/well thickness]
- vein segments above/below the knee
- target coronary artery grafted territory
- target coronary artery diameter
- target coronary artery stenosis
- target coronary artery severity disease
- ascending aorta disease
- composite /uncomposite graft
- left ventricular function
Measured: six weeks
outcome hypothesis
§ Detection of long-term outcomes:
- MACE (major adverse cardiac events): death; myocardial infarction; revascularization (PCI or CABG) for ischemia or angina recurrence
- MACE related to vein-graft failure
- GF (vein-graft failure): at least 75% of stenosis;
- GO (vein-graft occlusion) at angiographic study
- to identify factors in addition to treatment assignment that are associated with variations in long-term outcomes and graft patency
- baseline demographic characteristics and medications used of two treatment arms (EVOH/CVH)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass Grafting SurgeryStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Giovanni Battista
- Sponsor type
- University, hospital or other
- Collaborators
- LivaNova
- Investigators
- Antonio Campanella, MD, Study chair, Department of Thoracic and Cardiovascular Surgery, San Giovanni Battista of Turin Hospital, Corso Bramante 88/90, 10126 Turin, ItalyMauro Rinaldi, MD, PhD, Principal investigator, Department of Thoracic and Cardiovascular Surgery, San Giovanni Battista of Turin Hospital, Corso Bramante 88/90, 10126 Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121341
- Sponsor's protocol ID
- CEI/7
- Acronym
- ESOS
- Status last verified
- Apr 2010
- First submitted
- 7 May 2010
- Last updated
- 20 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Campanella A, Bergamasco L, Macri L, Asioli S, Devotini R, Scipioni S, Barbaro S, Rispoli P, Rinaldi M. Endoscopic Saphenous harvesting with an Open CO2 System (ESOS) trial for coronary artery bypass grafting surgery: study protocol for a randomized controlled trial. Trials. 2011 Nov 18;12:243. doi: 10.1186/1745-6215-12-243.
PubMed 22098690
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESOS (Endoscopic Saphenous Harvesting With an Open CO2 System) Trial: a Prospective Randomized Trial for Coronary Artery Bypass Grafting (CABG) Surgery.
- ClinicalTrials.gov ID
- NCT01121341
- Acronym / sponsor ID
- ESOS / CEI/7
- Conditions
- Coronary Artery Bypass Grafting Surgery
- Keywords
- Endoscopic vein harvesting, Saphenous vein, Conventional vein harvesting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera San Giovanni BattistaUniversity, hospital or other
- Collaborators
- LivaNova
- Study start
- May 2010
- Primary completion
- Jun 2011 (estimated)
- First posted
- 12 May 2010 (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 ESOS (Endoscopic Saphenous harvesting with an Open CO2 System) trial is a prospective randomized trial for coronary artery bypass grafting (CABG) surgery to compare endoscopic open CO2 harvesting system versus conventional vein harvesting.
Detailed description
The ESOS (Endoscopic Saphenous harvesting with an Open CO2 System) trial is a prospective randomized trial for coronary artery bypass grafting (CABG) surgery to compare and to test improvement in wound healing, quality of life, safety/efficacy, cost-effectiveness, short and long-term outcomes and vein-graft patency after endoscopic open CO2 harvesting system versus conventional vein harvesting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVOH | Experimental | Procedure: Vein harvestingProcedure: Endoscopic vein with an open CO2 system harvesting |
| OVH | Active comparator | Procedure: Vein harvestingProcedure: Conventional vein harvesting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective planned CABG surgery
- First isolated CABG surgery
Key exclusion criteria (10 listed)
- Emergency revascularization: patients with hemodynamic instability or requiring inotropic or intra-aortic balloon support
- Previous cardiac surgery
- Planned concomitant valve surgery
- Very varicous veins
- Previous saphenectomy
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 |
|---|---|---|
| Vein harvestingEndoscopic versus conventional vein harvesting | Procedure or surgery | EVOH, OVH |
Primary outcome
Morbidity hypothesis
Time frame: six weeks
When compared to Conventional vein-graft harvesting (CVH) in CABG surgery · Does Endoscopic vein-graft open CO2 system harvesting (EVOH) reduce postoperative wound complications (composite endpoint of all complications or individual complications) assessed with ASEPSIS score?
Patient satisfaction hypothesis
Time frame: six weeks
· Does EVOH improve patient satisfaction, postoperative leg pain and quality of life assessed with VAS score and EUROQol-5D? * To compare health-related quality of life for the two treatment arms (EVOH/CVH) by intention-to-treat * To identify factors in addition to treatment assignment that are associated with variations in quality of life outcomes
Resource utilization hypothesis
Time frame: six weeks
When compared to Conventional vein-graft harvesting (CVH) in CABG surgery · Does EVOH affect resource utilization? * Harvesting time related to the length of vein segments * Harvesting closure time * CABG time * Mobility time * Hospital length of stay * Re-exploration for bleeding due to vein-graft bleed * Readmission for leg wound complications * Need for outpatient wound management resources * To compare total medical costs for the two treatment arms (EVOH/CVH) by intention-to-treat
Quality of vein harvesting hypothesis
Time frame: six weeks
When compared to Conventional vein-graft harvesting (CVH) in CABG surgery * Do EVOH compromises the quality of venous conduit harvested? * Number of harvested veins requiring repair * Number of repairs to each vein * Re-exploration for bleeding due to vein-graft bleed * Histological integrity * Specific secondary subanalysis adjusted for: * Preparation solution of the vein conduit * 20 ml autologous blood * 0,5 ml heparin (5000UI/ml) = 2500 UI * 2 ml papavarine (30mg/ml) = 60 mg * Uncontrolled distension pressure/ no touch technique harvesting
2 secondary outcomes
Vein-graft patency hypothesis
Time frame: six weeks
outcome hypothesis
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2010.
- Derived from this study: PubMed 22098690Campanella A, Bergamasco L, Macri L, Asioli S, Devotini R, Scipioni S, Barbaro S, Rispoli P, Rinaldi M. Endoscopic Saphenous harvesting with an Open CO2 System (ESOS) trial for coronary artery bypass grafting surgery: study protocol for a randomized controlled trial. Trials. 2011 Nov 18;12:243. doi: 10.1186/1745-6215-12-243.
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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.
Antonio Campanella, MD study chair
Department of Thoracic and Cardiovascular Surgery, San Giovanni Battista of Turin Hospital, Corso Bramante 88/90, 10126 Turin, Italy
Mauro Rinaldi, MD, PhD principal investigator
Department of Thoracic and Cardiovascular Surgery, San Giovanni Battista of Turin Hospital, Corso Bramante 88/90, 10126 Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vein harvesting in people with Coronary Artery Bypass Grafting Surgery, run by Azienda Ospedaliera San Giovanni Battista at 1 site in Italy.
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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 20 May 2010. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Campanella, MD (+39 011 633 55 11, antoniocampanella@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity hypothesis (time frame: six weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01121341, which also lists 1 linked publication.
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 20 May 2010.