Coronary Artery DiseaseSAVERITANCT01051986
A Prospective Randomized Study for Comparison of Y-Composite Grafts
A study testing saphenous vein composite grafting and right internal thoracic artery composite grafting in people with Coronary Artery Disease, run by Seoul National University Hospital at 1 site in South Korea.
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). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- saphenous vein composite grafting and right internal thoracic artery composite grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2008to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age equal or more than 40
- age equal or less than 75
- patients who agree to the enrollment
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Comparison of the SAphenous VEin Versus Right Internal Thoracic Artery as a Y-Composite Graft (SAVE-RITA Trial)
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- saphenous vein composite grafting, right internal thoracic artery composite grafting
- Keywords
- coronary artery bypass, off-pump surgery, composite graft, saphenous vein, internal thoracic artery
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saphenous vein composite graftingProcedure or surgery
Also called SAVERITA SVG
use saphenous vein as a composite graft connected to the left internal thoracic artery
right internal thoracic artery composite graftingProcedure or surgery
Also called SAVERITA RITA
right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: right internal thoracic artery composite grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 Year Graft Patency Rates
1 year graft patency of second limb conduits measured by 1 year coronary angiography
Measured: one year
Secondary outcomes (4)
Overall Survival
Overall survival rate at 4 years
Measured: 4 years
Freedom From Cardiac Death
Freedom rate from cardiac death at 4 years
Measured: 4 years
Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)
freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years
Measured: 4 years
Early Angiographic Patency Rates
The patency rate of the SV side-arm composite graft evaluated with coronary angiograms early after CABG
Measured: 1.4days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startSep 2008
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki-Bong Kim, Seoul National University Hospital
- Investigators
- Ki-Bong Kim, MD, PhD, Principal investigator, Department of throacic and cardiovascular surgery, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051986
- Sponsor's protocol ID
- H-0803-024-237
- Acronym
- SAVERITA
- Status last verified
- Nov 2013
- First submitted
- 17 Jan 2010
- Last updated
- 10 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24973924
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of the SAphenous VEin Versus Right Internal Thoracic Artery as a Y-Composite Graft (SAVE-RITA Trial)
- ClinicalTrials.gov ID
- NCT01051986
- Acronym / sponsor ID
- SAVERITA / H-0803-024-237
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery bypass, off-pump surgery, composite graft, saphenous vein, internal thoracic artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Jan 2010 (estimated)
- Results
- Posted 10 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SVG group | Active comparator | Procedure: saphenous vein composite graftingpatients 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 |
| RITA group | Active comparator | Procedure: right internal thoracic artery composite graftingpatient 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 |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age equal or more than 40
- age equal or less than 75
- patients who agree to the enrollment
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| saphenous vein composite graftingAlso: SAVERITA SVGuse saphenous vein as a composite graft connected to the left internal thoracic artery | Procedure or surgery | SVG group |
| right internal thoracic artery composite graftingAlso: SAVERITA RITAright internal thoracic artery is used as a composite graft connected to the left internal thoracic artery | Procedure or surgery | RITA group |
Primary outcome
1 Year Graft Patency Rates
Time frame: one year
1 year graft patency of second limb conduits measured by 1 year coronary angiography
4 secondary outcomes
Overall Survival
Time frame: 4 years
Freedom From Cardiac Death
Time frame: 4 years
Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)
Time frame: 4 years
Early Angiographic Patency Rates
Time frame: 1.4days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24973924Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ki-Bong Kim, MD, PhD principal investigator
Department of throacic and cardiovascular surgery, Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing saphenous vein composite grafting and right internal thoracic artery composite grafting in people with Coronary Artery Disease, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 Year Graft Patency Rates (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01051986, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2014.