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Completed

NCT Number: NCT01051986

A Prospective Randomized Study for Comparison of Y-Composite Grafts

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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National Uinversity Hospital

Seoul, 110 744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

saphenous vein composite grafting

Procedure

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

Other names: SAVERITA SVG

right internal thoracic artery composite grafting

Procedure

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

Other names: SAVERITA RITA

Primary outcomes

  1. 1 Year Graft Patency Rates

    Time frame: one year

    1 year graft patency of second limb conduits measured by 1 year coronary angiography

Secondary outcomes

  1. Overall Survival

    Time frame: 4 years

    Overall survival rate at 4 years

  2. Freedom From Cardiac Death

    Time frame: 4 years

    Freedom rate from cardiac death at 4 years

  3. 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. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Acronym: SAVERITA

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jan 20, 2010
Registry last updated
Jan 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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