A Prospective Randomized Study for Comparison of Y-Composite Grafts

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to compare early and 1-year graft patency rates of saphenous vein composite grafts with those of right internal thoracic artery composite graft and mid-term clinical outcomes in patients who undergo off-pump coronary artery bypass grafting(OPCAB). We also evaluate microscopic findings of saphenous vein graft harvested no touch technique and used as composite graft.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Saphenous Vein as Y-composite Versus Aortocoronary Conduit for CABG

NCT05704296

Coronary Artery Disease

RECRUITING NA

IVUS Study for SV Graft: Y-composite vs Aortocoronary Conduit

NCT04782492

Coronary Artery Disease Morphologic Change

COMPLETED NA

Graft Patency Analysis of the Right Coronary Artery System

NCT01559350

Coronary Artery Disease

TERMINATED

Comparison of Saphenous Vein Graft Harvested From Upper Versus Lower Leg in Coronary Artery Bypass Grafting

NCT01974492

Triple Vessel Disease Unstable Angina Stable Angina +1 more

COMPLETED NA

Proximal Versus Distal Segments of No-Touch Saphenous Vein Grafts

NCT04284956

Leg Wound Complication After No-Touch Harvestingof Veins

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The SAVERITA trial was designed as a randomized, controlled trial to recruit 224 patients who undergo off-pump coronary artery bypass using Y-composite graft based on the left internal thoracic artery. Patients were randomized by use of a randomization table. Composite conduit was made using saphenous vein or right internal thoracic artery according to the randomization result. The primary end point is to evaluate early and 1-year postoperative graft patency. The secondary end points are overall survival, freedom from cardiac death and freedom from MACCE(major adverse cardiac or cerebrovascular events). In saphenous vein group, 20 remnant saphenous vein specimen was evaluated histologically to compare the difference between composite grafted vein and manually dilated saphenous vein.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SVG group

patients who underwent off-pump coronary artery bypass using saphenous vein composite grafting based on the left internal thoracic artery

use saphenous vein as a composite graft connected to the left internal thoracic artery

Group Type ACTIVE_COMPARATOR

saphenous vein composite grafting

Intervention Type PROCEDURE

use saphenous vein as a composite graft connected to the left internal thoracic artery

RITA group

patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite grafting based on the left internal thoracic artery

use right internal thoracic artery as a composite graft connected to the left internal thoracic artery

Group Type ACTIVE_COMPARATOR

right internal thoracic artery composite grafting

Intervention Type PROCEDURE

right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

saphenous vein composite grafting

use saphenous vein as a composite graft connected to the left internal thoracic artery

Intervention Type PROCEDURE

right internal thoracic artery composite grafting

right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

SAVERITA SVG SAVERITA RITA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age equal or more than 40
* age equal or less than 75
* patients who agree to the enrollment

Exclusion Criteria

* Patients with heart failure (left ventricular ejection fraction \< 25%)
* patients who have intractable ventricular arrhythmia
* patients who has been treated for cancer
* patients who has infectious disease
* patients who are planned to undergo combined cardiac surgery
* patients who has medical co-morbidity with expected survival less than 1 year
* patients who has a problem using right internal thoracic artery or saphenous vein
* patients with a history of previous cardiac surgery
* Patients with chronic renal failure
* patients who undergo emergency operation

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No