Coronary Artery DiseaseNCT05757947
Study of the No-touch Saphenous Vein Graft
A study testing Сoronary bypass surgery according to the I-graft method and Сoronary bypass surgery by the method of free conduit in people with Coronary Artery Disease and Coronary Artery Stenosis, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
Authors hypothesize that "no-touch" saphenous vein as I graft is superior over conventional "no-touch" saphenous vein as free graft in the incidence of graft patency. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Stenosis, Graft Failure
- What is being tested?
- Сoronary bypass surgery according to the I-graft method and Сoronary bypass surgery by the method of free conduit
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteRussia
- Study dates
- 22 Dec 2022to 22 Dec 2025
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with coronary artery disease requiring three-vessel myocardial revascularization
- Patient consent to the study
Who cannot join
- The diameter of the target arteries for conduits of the internal mammary arteries is less than 1 mm
- Hemodynamically significant atherosclerosis of the subclavian arteries in the first segment
- Stenosis of the right coronary artery less than 90%
- Concomitant pathology requiring additional simultaneous surgical correction
- Lack of IMA
- COPD with FEV1 <60%
Show all 14Show fewer
- BMI >35
- Prior heart surgery
- Oncological diseases with a life expectancy of less than 5 years
- ACS
- CKD stage 4 and higher
- The diameter of the SVG is less than 2 mm or its varicose expansion is more than 6 mm
- CLTI IIb and more
- Atherosclerosis of the brachiocephalic artery more than 50%
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
NMCR named after academician E.N. Meshalkin of the Ministry of Health of rhe Russian
Novosibirsk, Novosibirsk Oblast, 630055
Dmitry A Sirota, MD, +79132012140, sirotad@yandex.ru
Dmitry Khvan, +79069090505, dmhvan@mail.ru
About this study
Official title: Multicenter Clinical Trial of Myocardial Revascularization Using I-conduit and No-touch Saphenous Vein Graft
Authors hypothesize that "no-touch" saphenous vein as I graft is superior over conventional "no-touch" saphenous vein as free graft in the incidence of graft patency.
Read the detailed description
A multicenter single blind prospective randomized superiority study is conducted. Our hypothesis is that there is difference in the incidence of "no-touch" saphenous vein graft patency using it as the conventional free graft (group C) and I graft (group I) for myocardial revascularization more than 28%. If there is truly difference between groups, then total 106 patients for both groups are required to be 90% sure that the upper limit of a one-sided 95% confidence interval would reveal a difference in favour of the "no-touch" saphenous vein I graft of 28%. The blinding process is applied to a patient, who is informed about received harvesting method of saphenous vein, but don't know the type of the graft cofiguration. The study was approved by Institutional Review Board. Depending on a type of the procedure, the patients are divided into two groups: conventional free graft (group C) 53 patients and I graft (group I) 53 patients. Randomization is conducted befor operation by using accidental sampling.
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Graft Failure, Cardiac Ischemia, Surgery
- Being tested
- Сoronary bypass surgery according to the I-graft method, Сoronary bypass surgery by the method of free conduit
- Keywords
- no-touch saphenous vein graft; CABG
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Сoronary bypass surgery according to the I-graft methodProcedure or surgery
Revascularization of the right coronary artery basin will be performed using "no-touch" SVG and the formation of an anastomosis of the stump of the right internal mammary artery and end-to-end saphenous vein graft.
Сoronary bypass surgery by the method of free conduitProcedure or surgery
Revascularization of the right coronary artery basin will be performed using "no-touch" SVG and anastomosis of the saphenous vein graft to aorta.
| Study group | Role | What they receive |
|---|---|---|
| "no-touch" saphenous vein as I-graft | Active comparator | Coronary bypass surgery according to the I-graft method. Proximal anastomosis to RIMA. Receives: Procedure: Сoronary bypass surgery according to the I-graft method |
| "no-touch" saphenous vein as conventional free graft | Active comparator | Coronary artery bypass grafting using the free conduit technique. Proximal anastomosis to aorta. Receives: Procedure: Сoronary bypass surgery by the method of free conduit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patency of "no-touch" saphenous vein graft
Assessment of the patency of coronary shunts
Measured: 12 months after surgery
Secondary outcomes (4)
Recurrence of angina pectoris
Estimated percentage of participants with symptomatic angina at 6 and 12 months after surgery
Measured: 6 and 12 months after after surgery
MACE
Estimated percentage of participants with major adverse cardiac events at 6 and 12 months post-surgery
Measured: 6 and 12 months after after surgery
Complications of the conduit fence site
Estimated percentage of participants with wound complications, development of wound infection, postoperative neurological complications at the sampling site at 6 and 12 months after surgery
Measured: 6 and 12 months after after surgery
Survival rate
Estimated percentage of participants who died at 6 and 12 months after surgery
Measured: 6 and 12 months after after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start22 Dec 2022
- Primary completion1 Apr 2025 (estimated)
- Study completion22 Dec 2025 (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.
- 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
- Participant
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Dmitry Khvan, Meshalkin Research Institute of Pathology of Circulation
- Investigators
- Dmitry Khvan, Ph.D., Principal investigator, NMCR named after academician E.N. Meshalkin of the Ministry of Health of rhe Russian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757947
- Sponsor's protocol ID
- Super-SVG
- Status last verified
- Feb 2024
- First submitted
- 24 Feb 2023
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Clinical Trial of Myocardial Revascularization Using I-conduit and No-touch Saphenous Vein Graft
- ClinicalTrials.gov ID
- NCT05757947
- Acronym / sponsor ID
- Super-SVG
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Graft Failure, Cardiac Ischemia, Surgery
- Keywords
- no-touch saphenous vein graft; CABG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 22 Dec 2025 (estimated)
- First posted
- 7 Mar 2023 (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.
Authors hypothesize that "no-touch" saphenous vein as I graft is superior over conventional "no-touch" saphenous vein as free graft in the incidence of graft patency.
Detailed description
A multicenter single blind prospective randomized superiority study is conducted. Our hypothesis is that there is difference in the incidence of "no-touch" saphenous vein graft patency using it as the conventional free graft (group C) and I graft (group I) for myocardial revascularization more than 28%. If there is truly difference between groups, then total 106 patients for both groups are required to be 90% sure that the upper limit of a one-sided 95% confidence interval would reveal a difference in favour of the "no-touch" saphenous vein I graft of 28%. The blinding process is applied to a patient, who is informed about received harvesting method of saphenous vein, but don't know the type of the graft cofiguration. The study was approved by Institutional Review Board. Depending on a type of the procedure, the patients are divided into two groups: conventional free graft (group C) 53 patients and I graft (group I) 53 patients. Randomization is conducted befor operation by using accidental sampling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "no-touch" saphenous vein as I-graft | Active comparator | Procedure: Сoronary bypass surgery according to the I-graft methodCoronary bypass surgery according to the I-graft method. Proximal anastomosis to RIMA. |
| "no-touch" saphenous vein as conventional free graft | Active comparator | Procedure: Сoronary bypass surgery by the method of free conduitCoronary artery bypass grafting using the free conduit technique. Proximal anastomosis to aorta. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with coronary artery disease requiring three-vessel myocardial revascularization
- Patient consent to the study
Key exclusion criteria (14 listed)
- The diameter of the target arteries for conduits of the internal mammary arteries is less than 1 mm
- Hemodynamically significant atherosclerosis of the subclavian arteries in the first segment
- Stenosis of the right coronary artery less than 90%
- Concomitant pathology requiring additional simultaneous surgical correction
- Lack of IMA
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 |
|---|---|---|
| Сoronary bypass surgery according to the I-graft methodRevascularization of the right coronary artery basin will be performed using "no-touch" SVG and the formation of an anastomosis of the stump of the right internal mammary artery and end-to-end saphenous vein graft. | Procedure or surgery | "no-touch" saphenous vein as I-graft |
| Сoronary bypass surgery by the method of free conduitRevascularization of the right coronary artery basin will be performed using "no-touch" SVG and anastomosis of the saphenous vein graft to aorta. | Procedure or surgery | "no-touch" saphenous vein as conventional free graft |
Primary outcome
Patency of "no-touch" saphenous vein graft
Time frame: 12 months after surgery
Assessment of the patency of coronary shunts
4 secondary outcomes
Recurrence of angina pectoris
Time frame: 6 and 12 months after after surgery
MACE
Time frame: 6 and 12 months after after surgery
Complications of the conduit fence site
Time frame: 6 and 12 months after after surgery
Survival rate
Time frame: 6 and 12 months after after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
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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.
Dmitry Khvan, Ph.D. principal investigator
NMCR named after academician E.N. Meshalkin of the Ministry of Health of rhe Russian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Сoronary bypass surgery according to the I-graft method and Сoronary bypass surgery by the method of free conduit in people with Coronary Artery Disease and Coronary Artery Stenosis, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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 14 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 8 Feb 2024. 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 Russia. 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 Dmitry Khvan, Ph.D. (+79069090505, dmhvan@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patency of "no-touch" saphenous vein graft (time frame: 12 months after surgery). 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 8 Feb 2024.