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

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ClinicalTrials.gov Identifier: NCT01051986
Recruitment Status : Completed
First Posted : January 20, 2010
Results First Posted : January 10, 2014
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Coronary Artery Disease Procedure: saphenous vein composite grafting Procedure: right internal thoracic artery composite grafting

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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)
Study Start Date : September 2008
Primary Completion Date : December 2012
Study Completion Date : December 2012
Arms and Interventions

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 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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: January 20, 2010    Key Record Dates
Results First Posted: January 10, 2014
Last Update Posted: January 10, 2014
Last Verified: November 2013

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

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