Study of the No-touch Saphenous Vein Graft

Coronary Artery Disease Clinical Trial

Official title:

Multicenter Clinical Trial of Myocardial Revascularization Using I-conduit and No-touch Saphenous Vein Graft

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05757947
• Other study ID #: Super-SVG
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2022
• Est. completion date: December 22, 2025

Study information

• Verified date: February 2024
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Dmitry Khvan, Ph.D.
• Phone: +79069090505
• Email: dmhvan[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: December 22, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with coronary artery disease requiring three-vessel myocardial revascularization

• Patient consent to the study

Exclusion Criteria:

• 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%

• 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%

Related Conditions & MeSH terms

• Cardiac Ischemia
• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Stenosis
• Graft Failure
• Ischemia
• Myocardial Ischemia
• Surgery

Intervention

Procedure:
• ?oronary bypass surgery according to the I-graft method
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.
• ?oronary bypass surgery by the method of free conduit
Revascularization of the right coronary artery basin will be performed using "no-touch" SVG and anastomosis of the saphenous vein graft to aorta.

Locations

Country	Name	City	State
Russian Federation	NMCR named after academician E.N. Meshalkin of the Ministry of Health of rhe Russian	Novosibirsk	Novosibirsk Region

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patency of "no-touch" saphenous vein graft	Assessment of the patency of coronary shunts	12 months after surgery
Secondary	Recurrence of angina pectoris	Estimated percentage of participants with symptomatic angina at 6 and 12 months after surgery	6 and 12 months after after surgery
Secondary	MACE	Estimated percentage of participants with major adverse cardiac events at 6 and 12 months post-surgery	6 and 12 months after after surgery
Secondary	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	6 and 12 months after after surgery
Secondary	Survival rate	Estimated percentage of participants who died at 6 and 12 months after surgery	6 and 12 months after after surgery