Study of the No-touch Saphenous Vein Graft

NCT ID: NCT05757947

Last Updated: 2024-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-22

Study Completion Date

2025-12-22

Brief Summary

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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

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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

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Coronary Artery Disease Coronary Artery Stenosis Graft Failure Cardiac Ischemia Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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"no-touch" saphenous vein as I-graft

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

Group Type ACTIVE_COMPARATOR

Сoronary bypass surgery according to the I-graft method

Intervention Type PROCEDURE

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.

"no-touch" saphenous vein as conventional free graft

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

Group Type ACTIVE_COMPARATOR

Сoronary bypass surgery by the method of free conduit

Intervention Type PROCEDURE

Revascularization of the right coronary artery basin will be performed using "no-touch" SVG and anastomosis of the saphenous vein graft to aorta.

Interventions

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Сoronary 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.

Intervention Type 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 anastomosis of the saphenous vein graft to aorta.

Intervention Type PROCEDURE

Eligibility Criteria

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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%
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

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Dmitry Khvan

candidate of medical sciences, senior researcher, сardiovascular surgeon of the NMRC named after academician E.N. Meshalkin of the Ministry of Health of Russian Federation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dmitry Khvan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Novosibirsk, Novosibirsk Oblast, Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Dmitry Khvan, Ph.D.

Role: CONTACT

+79069090505

Facility Contacts

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Dmitry A Sirota, MD

Role: primary

+79132012140

Dmitry Khvan

Role: backup

+79069090505

Other Identifiers

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Super-SVG

Identifier Type: -

Identifier Source: org_study_id

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