A Prospective Randomized Study for Comparison of Y-Composite Grafts (SAVERITA)

November 21, 2013 updated by: Ki-Bong Kim, Seoul National University Hospital

A Randomized Comparison of the SAphenous VEin Versus Right Internal Thoracic Artery as a Y-Composite Graft (SAVE-RITA Trial)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110 744
        • Seoul National Uinversity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Procedure: saphenous vein composite grafting
use saphenous vein as a composite graft connected to the left internal thoracic artery
Other Names:
  • SAVERITA SVG
Active Comparator: 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
Procedure: right internal thoracic artery composite grafting
right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery
Other Names:
  • SAVERITA RITA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1 Year Graft Patency Rates
Time Frame: one year
1 year graft patency of second limb conduits measured by 1 year coronary angiography
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 4 years
Overall survival rate at 4 years
4 years
Freedom From Cardiac Death
Time Frame: 4 years
Freedom rate from cardiac death at 4 years
4 years
Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)
Time Frame: 4 years
freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years
4 years
Early Angiographic Patency Rates
Time Frame: 1.4days
The patency rate of the SV side-arm composite graft evaluated with coronary angiograms early after CABG
1.4days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Ki-Bong Kim, MD, PhD, Department of throacic and cardiovascular surgery, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 17, 2010

First Submitted That Met QC Criteria

January 17, 2010

First Posted (Estimate)

January 20, 2010

Study Record Updates

Last Update Posted (Estimate)

January 10, 2014

Last Update Submitted That Met QC Criteria

November 21, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-0803-024-237

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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