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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ki-Bong Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01051986
First received: January 17, 2010
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Procedure: saphenous vein composite grafting
Procedure: right internal thoracic artery composite grafting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of the SAphenous VEin Versus Right Internal Thoracic Artery as a Y-Composite Graft (SAVE-RITA Trial)

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 1 Year Graft Patency Rates [ Time Frame: one year ] [ Designated as safety issue: No ]
    1 year graft patency of second limb conduits measured by 1 year coronary angiography


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Overall survival rate at 4 years

  • Freedom From Cardiac Death [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Freedom rate from cardiac death at 4 years

  • Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years

  • Early Angiographic Patency Rates [ Time Frame: 1.4days ] [ Designated as safety issue: No ]
    The patency rate of the SV side-arm composite graft evaluated with coronary angiograms early after CABG


Enrollment: 224
Study Start Date: September 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: SAVERITA RITA

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01051986

Locations
Korea, Republic of
Seoul National Uinversity Hospital
Seoul, Korea, Republic of, 110 744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Ki-Bong Kim, MD, PhD Department of throacic and cardiovascular surgery, Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Ki-Bong Kim, Professor and Chairman, Department of Thoracic and Cardiovascular Surgery, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01051986     History of Changes
Other Study ID Numbers: H-0803-024-237
Study First Received: January 17, 2010
Results First Received: May 29, 2013
Last Updated: November 21, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
coronary artery bypass
off-pump surgery
composite graft
saphenous vein
internal thoracic artery

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014