A Prospective Randomized Study for Comparison of Y-Composite Grafts

Coronary Artery Disease Clinical Trial

— SAVERITA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01051986
• Other study ID #: H-0803-024-237
• Status: Completed
• Phase: N/A
• First received: January 17, 2010
• Last updated: November 21, 2013
• Start date: September 2008
• Est. completion date: December 2012

Study information

• Verified date: November 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• saphenous vein composite grafting
use saphenous vein as a composite graft connected to the left internal thoracic artery
• right internal thoracic artery composite grafting
right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Uinversity Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1 Year Graft Patency Rates	1 year graft patency of second limb conduits measured by 1 year coronary angiography	one year	No
Secondary	Overall Survival	Overall survival rate at 4 years	4 years	No
Secondary	Freedom From Cardiac Death	Freedom rate from cardiac death at 4 years	4 years	No
Secondary	Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)	freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years	4 years	No
Secondary	Early Angiographic Patency Rates	The patency rate of the SV side-arm composite graft evaluated with coronary angiograms early after CABG	1.4days	No