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Study of the No-touch Saphenous Vein Graft

Primary Purpose

Coronary Artery Disease, Coronary Artery Stenosis, Graft Failure

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Сoronary bypass surgery according to the I-graft method
Сoronary bypass surgery by the method of free conduit
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring no-touch saphenous vein graft; CABG

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 HAV 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.

Sites / Locations

  • NMCR named after academician E.N. Meshalkin of the Ministry of Health of rhe RussianRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

"no-touch" saphenous vein as I-graft

"no-touch" saphenous vein as conventional free graft

Arm Description

Coronary bypass surgery according to the I-graft method. Proximal anastomosis to RIMA.

Coronary artery bypass grafting using the free conduit technique. Proximal anastomosis to aorta.

Outcomes

Primary Outcome Measures

Patency of "no-touch" saphenous vein graft
Assessment of the patency of coronary shunts

Secondary Outcome Measures

Recurrence of angina pectoris
Estimated percentage of participants with symptomatic angina at 6 and 12 months after surgery
MACE
Estimated percentage of participants with major adverse cardiac events at 6 and 12 months post-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
Survival rate
Estimated percentage of participants who died at 6 and 12 months after surgery

Full Information

First Posted
February 24, 2023
Last Updated
February 24, 2023
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT05757947
Brief Title
Study of the No-touch Saphenous Vein Graft
Official Title
Multicenter Clinical Trial of Myocardial Revascularization Using I-conduit and No-touch Saphenous Vein Graft
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2022 (Actual)
Primary Completion Date
December 22, 2023 (Anticipated)
Study Completion Date
December 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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 25%. 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 25%. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Artery Stenosis, Graft Failure, Cardiac Ischemia, Surgery
Keywords
no-touch saphenous vein graft; CABG

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
"no-touch" saphenous vein as I-graft
Arm Type
Active Comparator
Arm Description
Coronary bypass surgery according to the I-graft method. Proximal anastomosis to RIMA.
Arm Title
"no-touch" saphenous vein as conventional free graft
Arm Type
Active Comparator
Arm Description
Coronary artery bypass grafting using the free conduit technique. Proximal anastomosis to aorta.
Intervention Type
Procedure
Intervention Name(s)
Сoronary bypass surgery according to the I-graft method
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Сoronary bypass surgery by the method of free conduit
Intervention Description
Revascularization of the right coronary artery basin will be performed using "no-touch" SVG and anastomosis of the saphenous vein graft to aorta.
Primary Outcome Measure Information:
Title
Patency of "no-touch" saphenous vein graft
Description
Assessment of the patency of coronary shunts
Time Frame
12 months after surgery
Secondary Outcome Measure Information:
Title
Recurrence of angina pectoris
Description
Estimated percentage of participants with symptomatic angina at 6 and 12 months after surgery
Time Frame
6 and 12 months after after surgery
Title
MACE
Description
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
Title
Complications of the conduit fence site
Description
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
Title
Survival rate
Description
Estimated percentage of participants who died at 6 and 12 months after surgery
Time Frame
6 and 12 months after after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 HAV 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dmitry Khvan, Ph.D.
Phone
+79069090505
Email
dmhvan@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dmitry Khvan, Ph.D.
Organizational Affiliation
NMCR named after academician E.N. Meshalkin of the Ministry of Health of rhe Russian
Official's Role
Principal Investigator
Facility Information:
Facility Name
NMCR named after academician E.N. Meshalkin of the Ministry of Health of rhe Russian
City
Novosibirsk
State/Province
Novosibirsk Region
ZIP/Postal Code
630055
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dmitry A Sirota, MD
Phone
+79132012140
Email
sirotad@yandex.ru
First Name & Middle Initial & Last Name & Degree
Dmitry Khvan
Phone
+79069090505
Email
dmhvan@mail.ru

12. IPD Sharing Statement

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Study of the No-touch Saphenous Vein Graft

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