A Prospective Randomized Study for Comparison of Y-Composite Grafts

NCT01051986 | Completed Results

• 1 other identifier: H-0803-024-237
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

coronary artery bypass; off-pump surgery; composite graft; saphenous vein; internal thoracic artery

Outcome Measures

Primary Outcomes (1)

• 1 Year Graft Patency Rates

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

  one year

Secondary Outcomes (4)

• Overall Survival

  4 years

• Freedom From Cardiac Death

  4 years

• Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)

  4 years

• Early Angiographic Patency Rates

  1.4days

Study Arms (2)

SVG group

ACTIVE COMPARATOR

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

RITA group

ACTIVE COMPARATOR

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

Interventions

saphenous vein composite grafting PROCEDURE

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

Also known as: SAVERITA SVG

SVG group

right internal thoracic artery composite grafting PROCEDURE

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

Also known as: SAVERITA RITA

RITA group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age equal or more than 40
• age equal or less than 75
• patients who agree to the enrollment

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National Uinversity Hospital

Seoul, 110 744, South Korea

Location

Related Publications (1)

• Kim KB, Hwang HY, Hahn S, Kim JS, Oh SJ. A randomized comparison of the Saphenous Vein Versus Right Internal Thoracic Artery as a Y-Composite Graft (SAVE RITA) trial: One-year angiographic results and mid-term clinical outcomes. J Thorac Cardiovasc Surg. 2014 Sep;148(3):901-7; discussion 907-8. doi: 10.1016/j.jtcvs.2014.03.057. Epub 2014 May 16.

  PMID: 24973924 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

the current study is not a multicenter "all-comers" study, although it is a prospective, randomized, controlled trial. The 1-year graft patency rates and clinical outcomes of 34 months do not provide sufficient data to reach a definite conclusion

Results Point of Contact

• Title: Ki-Bong Kim
• Organization: Seoul National University Hospital

kimkb@snu.ac.kr

+82-2-2072-3482

Study Officials

• Ki-Bong Kim, MD, PhD

  Department of throacic and cardiovascular surgery, Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Thoracic and Cardiovascular Surgery

Study Record Dates

• First Submitted: January 17, 2010
• First Posted: January 20, 2010
• Study Start: September 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 10, 2014
• Results First Posted: January 10, 2014

Record last verified: 2013-11

Locations

KR (1)