Coronary Artery DiseaseNCT03966222
Comparison of Saphenous Vein Harvesting by Endoscopic Versus Open Conventional Methods
A study testing Endoscopic vein harvest and Open vein harvest in people with Coronary Artery Disease, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to investigate the histological and immunohistochemical findings of the saphenous vein graft, to rule out endothelial damage as a direct result of manipulation or instrumentation by endoscopic and open conventional harvesting methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Endoscopic vein harvest and Open vein harvest
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2020to 1 Jul 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients over the age of 18;
- Patients with ischemic heart disease who are planned to undergo CABG surgery;
- A vein graft in necessary for the revascularization;
- There is no indication for one specific method for vein harvesting;
- Informed consent obtained.
Who cannot join
- Patients who undergo a non-elective surgery
- Concomitant procedures during the CABG surgery;
- Any known infection in the past 6 months;
- Evidence of vein thrombosis in an ultrasound study prior to surgery;
- Morbid obesity patients;
- Patients with peripheral vascular disease;
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- Patients who would gain from one technique more than the other by any reason (according to the surgeon or investigator opinion);
- Severe primary mitral and aortic valve stenosis or regurgitation;
- Patients who have undergone a previous cardiac surgery from any kind;
- Patients who underwent any surgery in the lower extremities in the past (i.e. orthopedic, vascular, etc.);
- Any serious disease likely to interfere with the conduct of the study;
- Participation in other clinical trial;
- Patients geographically not stable or unavailable for follow-up.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Eilon Ram, M.D., 526669119 ext. 972, eilonram@gmail.com
About this study
Official title: Clinical and Histological Evaluation of Saphenous Vein Harvesting by Endoscopic and Open Conventional Methods
The aim of this study is to investigate the histological and immunohistochemical findings of the saphenous vein graft, to rule out endothelial damage as a direct result of manipulation or instrumentation by endoscopic and open conventional harvesting methods. Furthermore, to investigate if there are any differences in the surgical site infection, cardiac event and functional status between the two harvest strategies at 1-year of follow-up.
Read the detailed description
BACKGROUND Ischemic heart disease is the leading cause of death globally that accounts for about 7.4 million mortalities worldwide annually as published by the World Health Organization. Coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) are the options for revascularization in patients suffering from coronary artery disease (CAD). The choice of the most appropriate modality is affected by the clinical presentation, comorbidities, anatomical complexity of the CAD, and baseline characteristics of the patient. Although advances in PCI with drug-eluting stents have provide good outcomes, CABG remains an important revascularization strategy in the treatment of CAD.
The initial experience of using saphenous vein as coronary bypass conduits was first published from the Cleveland clinic in 1967. Minimally invasive endoscopic vein harvest (EVH) was first reported in 1996 as an alternative to open vein harvest (OVH). An endoscope is introduced adjacent to the vein, allowing its dissection under direct vision via a small incision. Over the last decade, EVH has become the preferred technique for conduit harvest in many cardiothoracic centers owing to the overall reduction in complications compared with OVH and the obvious cosmetic advantage. However, concerns persist regarding the risk of microscopic damage incurred during EVH, and the consequences of this for long-term graft patency.
OBJECTIVES The aim of this study is to investigate the histological and immunohistochemical findings of the saphenous vein graft, to rule out endothelial damage as a direct result of manipulation or instrumentation by endoscopic and open conventional harvesting methods. Furthermore, to investigate if there are any differences in the surgical site infection, cardiac event and functional status between the two harvest strategies at 1-year of follow-up.
METHODS This is a prospective, single-center randomized controlled trial conducted in the department of cardiac surgery at the Sheba Medical Center. It will include a sample size of 50 patients (randomization ratio 1:1), who are planned to undergo an elective isolated CABG surgery, and a vein graft is necessary for the revascularization.
- Conditions
- Coronary Artery Disease
- Being tested
- Endoscopic vein harvest, Open vein harvest
- Keywords
- Vein graft
- 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 harvestDevice
An endoscope is introduced adjacent to the vein, allowing its dissection under direct vision via a small incision.
Open vein harvestOther
Open vein harvest
| Study group | Role | What they receive |
|---|---|---|
| Open vein harvest | Active comparator | For the standard open conventional technique, the saphenous vein will be exposed by a longitudinal leg incision starting from the medial malleolus and ending at the upper medial thigh at the sapheno-femoral junction. The saphenous vein will be dissected free from its perivascular fat pedicle and visible side branches will be ligated and divided. Receives: Other: Open vein harvest |
| Endoscopic vein harvest | Experimental | We will use the Terumo VirtuoSaph® Plus Endoscopic Vessel Harvesting System for all endoscopic vein extractions, which is an open carbon dioxide (CO2) system. Approximately 6 l/min of CO2 will be continuously insufflated in the subcutaneous tunnel. Receives: Device: Endoscopic vein harvest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microscopic vein damage by histology examination
The amount of preserved endothelium and endothelial stretching seen in the histology examination in the two different vein harvesting strategies.
Measured: Immediate
Secondary outcomes (2)
Rehospitalization, myocardial infarction and all-cause mortality
Composite end point of rehospitalization, myocardial infarction and all-cause mortality up to 1-year.
Measured: 12 months
New-York Heart Association (NYHA) functional class
New-York Heart Association (NYHA) functional class at 1-year
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start1 Jan 2020
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
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 Sheba Medical CenterThe 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
- Model description
- Prospective, randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Eilon Ram, Sheba Medical Center
- Investigators
- Leonid Sternik, M.D., Study director, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966222
- Sponsor's protocol ID
- Sheba-19-6192-ER-CTIL
- Status last verified
- Sep 2021
- First submitted
- 27 May 2019
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Histological Evaluation of Saphenous Vein Harvesting by Endoscopic and Open Conventional Methods
- ClinicalTrials.gov ID
- NCT03966222
- Acronym / sponsor ID
- Sheba-19-6192-ER-CTIL
- Conditions
- Coronary Artery Disease
- Keywords
- Vein graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 29 May 2019 (actual)
- 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 aim of this study is to investigate the histological and immunohistochemical findings of the saphenous vein graft, to rule out endothelial damage as a direct result of manipulation or instrumentation by endoscopic and open conventional harvesting methods. Furthermore, to investigate if there are any differences in the surgical site infection, cardiac event and functional status between the two harvest strategies at 1-year of follow-up.
Detailed description
BACKGROUND Ischemic heart disease is the leading cause of death globally that accounts for about 7.4 million mortalities worldwide annually as published by the World Health Organization. Coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) are the options for revascularization in patients suffering from coronary artery disease (CAD). The choice of the most appropriate modality is affected by the clinical presentation, comorbidities, anatomical complexity of the CAD, and baseline characteristics of the patient. Although advances in PCI with drug-eluting stents have provide good outcomes, CABG remains an important revascularization strategy in the treatment of CAD.
The initial experience of using saphenous vein as coronary bypass conduits was first published from the Cleveland clinic in 1967. Minimally invasive endoscopic vein harvest (EVH) was first reported in 1996 as an alternative to open vein harvest (OVH). An endoscope is introduced adjacent to the vein, allowing its dissection under direct vision via a small incision. Over the last decade, EVH has become the preferred technique for conduit harvest in many cardiothoracic centers owing to the overall reduction in complications compared with OVH and the obvious cosmetic advantage. However, concerns persist regarding the risk of microscopic damage incurred during EVH, and the consequences of this for long-term graft patency.
OBJECTIVES The aim of this study is to investigate the histological and immunohistochemical findings of the saphenous vein graft, to rule out endothelial damage as a direct result of manipulation or instrumentation by endoscopic and open conventional harvesting methods. Furthermore, to investigate if there are any differences in the surgical site infection, cardiac event and functional status between the two harvest strategies at 1-year of follow-up.
METHODS This is a prospective, single-center randomized controlled trial conducted in the department of cardiac surgery at the Sheba Medical Center. It will include a sample size of 50 patients (randomization ratio 1:1), who are planned to undergo an elective isolated CABG surgery, and a vein graft is necessary for the revascularization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Open vein harvest | Active comparator | Other: Open vein harvestFor the standard open conventional technique, the saphenous vein will be exposed by a longitudinal leg incision starting from the medial malleolus and ending at the upper medial thigh at the sapheno-femoral junction. The saphenous vein will be dissected free from its perivascular fat pedicle and visible side branches will be ligated and divided. |
| Endoscopic vein harvest | Experimental | Device: Endoscopic vein harvestWe will use the Terumo VirtuoSaph® Plus Endoscopic Vessel Harvesting System for all endoscopic vein extractions, which is an open carbon dioxide (CO2) system. Approximately 6 l/min of CO2 will be continuously insufflated in the subcutaneous tunnel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients over the age of 18;
- Patients with ischemic heart disease who are planned to undergo CABG surgery;
- A vein graft in necessary for the revascularization;
- There is no indication for one specific method for vein harvesting;
- Informed consent obtained.
Key exclusion criteria (13 listed)
- Patients who undergo a non-elective surgery
- Concomitant procedures during the CABG surgery;
- Any known infection in the past 6 months;
- Evidence of vein thrombosis in an ultrasound study prior to surgery;
- Morbid obesity patients;
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 harvestAn endoscope is introduced adjacent to the vein, allowing its dissection under direct vision via a small incision. | Device | Endoscopic vein harvest |
| Open vein harvestOpen vein harvest | Other | Open vein harvest |
Primary outcome
Microscopic vein damage by histology examination
Time frame: Immediate
The amount of preserved endothelium and endothelial stretching seen in the histology examination in the two different vein harvesting strategies.
2 secondary outcomes
Rehospitalization, myocardial infarction and all-cause mortality
Time frame: 12 months
New-York Heart Association (NYHA) functional class
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Leonid Sternik, M.D. study director
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic vein harvest and Open vein harvest in people with Coronary Artery Disease, run by Sheba Medical Center at 1 site in Israel.
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 5 inclusion and 13 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 22 Sep 2021. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eilon Ram, M.D. (3-5302710 ext. 972, eilon.ram@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microscopic vein damage by histology examination (time frame: Immediate). 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 22 Sep 2021.