An interventional study of Сoronary bypass surgery according to the I-graft method and Сoronary bypass surgery by the method of free conduit in Coronary Artery Disease, Coronary Artery Stenosis and Graft Failure, sponsored by Meshalkin Research Institute of Pathology of Circulation. Recruiting at 1 site in Russian Federation. Open to participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-02-08.
Sponsored by Meshalkin Research Institute of Pathology of Circulation · Not applicable, Interventional, and Treatment
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.
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.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 106 is below the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Meshalkin Research Institute of Pathology of Circulation is the lead sponsor of 119 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Coronary bypass surgery according to the I-graft method. Proximal anastomosis to RIMA.
Procedure: Сoronary bypass surgery according to the I-graft method
Coronary artery bypass grafting using the free conduit technique. Proximal anastomosis to aorta.
Procedure: Сoronary bypass surgery by the method of free conduit
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.
Revascularization of the right coronary artery basin will be performed using "no-touch" SVG and anastomosis of the saphenous vein graft to aorta.
Patency of "no-touch" saphenous vein graft
Assessment of the patency of coronary shunts
Time frame: 12 months after surgery
Recurrence of angina pectoris
Estimated percentage of participants with symptomatic angina at 6 and 12 months after surgery
Time frame: 6 and 12 months after after surgery
MACE
Estimated percentage of participants with major adverse cardiac events at 6 and 12 months post-surgery
Time frame: 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
Time frame: 6 and 12 months after after surgery
Survival rate
Estimated percentage of participants who died at 6 and 12 months after surgery
Time frame: 6 and 12 months after after surgery
Started Dec 2022 (actual). Primary completion is estimated for Apr 2025, 27 months after the start.
Of 753 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 27 months is below that.
Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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Meshalkin Research Institute of Pathology of Circulation →