Coronary Artery DiseaseSAVE-ITNCT02173860
Strategies for Revascularization in Patients Undergoing Heart Valve Surgery With Concomitant Coronary Artery Disease
A study testing FFR-guided surgical revascularization and Angio-guided surgical revascularization in people with Coronary Artery Disease and Valvular Heart Disease, run by Portuguese Society of Cardiology at 1 site in Portugal.
Trial summary
The purpose of this study is to determine whether, in patients undergoing elective valvular heart surgery, revascularization of concomitant coronary artery disease (CAD) guided by FFR (Fractional flow reserve) would be superior to standard angiography-guided-revascularization approach on major efficacy and safety… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Valvular Heart Disease
- What is being tested?
- FFR-guided surgical revascularization and Angio-guided surgical revascularization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 502 participants
- Where
- 1 sitePortugal
- Study dates
- Jul 2016to Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Severe heart valve disease with indication for an elective cardiac with a St. Jude Medical Heart Valve
- Concomitant significant CAD (at least one epicardial vessel with a stenosis> 50%)
- Willing and able to provide informed written consent
Who cannot join
- Previous CABG
- Angiographic significant lesion involving left main lesion (patient is still eligible if right coronary artery is candidate for FFR measurement and surgical revascularization)
- All lesions in extremely tortuous or calcified coronary vessels
- Recent myocardial infarction (< 30 days)
- Cardiogenic shock or clinical instability (i.e. NYHA 4, uncontrolled arrhythmias, unexplained hypotension severe bradycardia or any other medical condition considered as a sign of instability by the assisting physician)
- Severe left ventricular dysfunction (EF < 35%)
Show all 10Show fewer
- Pregnant or are planning to become pregnant during the duration of the investigation
- Chronic renal dysfunction as defined as estimated glomerular filtration rate < 60 ml/min
- Life expectancy < 12 months
- Currently participating in any other clinical investigation
Trial locations and contacts
1 site in 1 country.
Mafalda Selas, RN contact
Portugal1 site, 1 recruiting
- Recruiting
Hospital Santa Marta, centro Hospitalar Lisboa Central
Lisbon, Lisbon District, 1169-024
Ruben Ramos, MD, +351963156910, ruben.a.b.ramos@gmail.com
Mafalda Selas, RN, +351213594000, mafalda.selas@gmail.com
About this study
Official title: Strategies for Revascularization in Patients Undergoing Heart Valve Surgery With Concomitant Coronary Artery Disease. AngIography vs Fractional Flow Reserve
The purpose of this study is to determine whether, in patients undergoing elective valvular heart surgery, revascularization of concomitant coronary artery disease (CAD) guided by FFR (Fractional flow reserve) would be superior to standard angiography-guided-revascularization approach on major efficacy and safety outcomes
Read the detailed description
The SAVE-IT trial is a multicenter, international, randomized, controlled, superiority trial. Patients scheduled to undergo elective valvular heart surgery will be screened for presence of concomitant coronary artery disease (CAD) by invasive coronary angiography. Patients with a stenosis > 50% in at least one epicardial vessel (excluding left main) considered suitable for surgical revascularization will be randomized to FFR guided- or standard angiography-guided surgical revascularization. A proportion of patients with no concomitant CAD will be followed in a parallel registry
Baseline clinical, laboratory, electrocardiographic and echocardiographic data will be obtained. Coronary anatomy severity will be assessed by quantitative coronary angiography (QCA) and Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (Syntax) score. Surgical risk will be assessed by Euroscore. Patients randomized to FFR-guided arm will have functional severity of the angiographic stenosis assessed by a St. Jude Medical coronary pressure wire measurement under hyperemic conditions using intravenous or intracoronary adenosine administration. If the FFR is ≤0.8 then a graft will be placed distal to the coronary stenosis. If the FFR is >0.8 no grafting will be performed to the epicardial vessel containing the stenosis. Patients will receive cardiac surgery no later than 8 weeks after randomization.
Peri-operative data will be collected. Clinical follow-up data will be collected at 1, 6 and 12 month after surgery. Graft patency at 12 months will be assessed by cardiac computed angiography (CCTA) for all patients who received at least one graft, except if an invasive coronary angiography has been performed in the preceding 3 months based on clinical grounds.
- Conditions
- Coronary Artery Disease, Valvular Heart Disease
- Being tested
- FFR-guided surgical revascularization, Angio-guided surgical revascularization
- Keywords
- Coronary artery disease, Valvular heart disease, Fractional flow reserve, Coronary artery bypass surgery, Coronary graft failure or patency
- Medical subject headings
- Coronary Artery Disease, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFR-guided surgical revascularizationProcedure or surgery
Also called Fractional Flow Reserve-Guided surgical revascularization
Angio-guided surgical revascularizationProcedure or surgery
Also called Coronary artery bypass graft guided by angiographic-only assessment of severity stenosis
| Study group | Role | What they receive |
|---|---|---|
| FFR-guided revascularization | Active comparator | Patients with valvular heart disease scheduled for elective cardiac surgery and concomitant significant coronary artery disease will have FFR measured with a St. Jude Medical coronary pressure wire across all lesions in vessels pre-specified as suitable for surgical revascularization. If the FFR is ≤0.80, then CABG will be performed. If the FFR is >0.80 then no graft will be placed in that particular vessel. Patients in whom FFR of a particular lesion is not possible can be included if at least one additional lesion is suitable for FFR measurement and grafting. Receives: Procedure: FFR-guided surgical revascularization |
| Angio-guided revascularization | Active comparator | Concomitant CABG will be performed as per clinical routine in all vessels with at least one stenosis > 50%. The vessel should be pre-specified as suitable for surgical revascularization before randomization. An internal mammary graft to the LAD should be attempted in all cases, if possible. Further revascularization strategy is left to the discretion of each center. Receives: Procedure: Angio-guided surgical revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACCE
Composite endpoint of death, nonfatal myocardial infarction, unplanned revascularization and stroke at 12 months. Subjects who die or are lost to follow up before 1 year will be censored at their last recorded activity.
Measured: 12 months
Graft failure
Graft patency as assessed by CCTA scheduled at 12 months. Graft status can also be assessed by invasive coronary angiography if clinically indicated.
Measured: 12 months
Secondary outcomes (2)
MACCE
death, nonfatal myocardial infarction, unplanned revascularization and stroke
Measured: 1 month
MACCE
death, nonfatal myocardial infarction, unplanned revascularization and stroke
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startJul 2016
- Primary completionJan 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 502 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Portuguese Society of Cardiology
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor
- Investigators
- Ruben Ramos, MD, Principal investigator, Hospital Santa Marta, Centro Hospitalar Lisboa CentralSergio Batista, MD, Principal investigator, Hospital Fernando da FonsecaLuis Raposo, MD, Principal investigator, Hospital de Santa Cruz, Centro Hospitalar de Lisboa CentralEmanuele Barbato, PhD, Principal investigator, Olzv-Aalst ClinicColin Berry, PhD, Principal investigator, Golden Jubilee National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173860
- Sponsor's protocol ID
- SAVEIT351
- Acronym
- SAVE-IT
- Status last verified
- Oct 2016
- First submitted
- 19 Jun 2014
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies for Revascularization in Patients Undergoing Heart Valve Surgery With Concomitant Coronary Artery Disease. AngIography vs Fractional Flow Reserve
- ClinicalTrials.gov ID
- NCT02173860
- Acronym / sponsor ID
- SAVE-IT / SAVEIT351
- Conditions
- Coronary Artery Disease, Valvular Heart Disease
- Keywords
- Coronary artery disease, Valvular heart disease, Fractional flow reserve, Coronary artery bypass surgery, Coronary graft failure or patency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 502 participants (estimated)
- Lead sponsor
- Portuguese Society of CardiologyUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- Jul 2016
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 25 Jun 2014 (estimated)
- Results
- Not posted in the source record
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 determine whether, in patients undergoing elective valvular heart surgery, revascularization of concomitant coronary artery disease (CAD) guided by FFR (Fractional flow reserve) would be superior to standard angiography-guided-revascularization approach on major efficacy and safety outcomes
Detailed description
The SAVE-IT trial is a multicenter, international, randomized, controlled, superiority trial. Patients scheduled to undergo elective valvular heart surgery will be screened for presence of concomitant coronary artery disease (CAD) by invasive coronary angiography. Patients with a stenosis > 50% in at least one epicardial vessel (excluding left main) considered suitable for surgical revascularization will be randomized to FFR guided- or standard angiography-guided surgical revascularization. A proportion of patients with no concomitant CAD will be followed in a parallel registry
Baseline clinical, laboratory, electrocardiographic and echocardiographic data will be obtained. Coronary anatomy severity will be assessed by quantitative coronary angiography (QCA) and Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (Syntax) score. Surgical risk will be assessed by Euroscore. Patients randomized to FFR-guided arm will have functional severity of the angiographic stenosis assessed by a St. Jude Medical coronary pressure wire measurement under hyperemic conditions using intravenous or intracoronary adenosine administration. If the FFR is ≤0.8 then a graft will be placed distal to the coronary stenosis. If the FFR is >0.8 no grafting will be performed to the epicardial vessel containing the stenosis. Patients will receive cardiac surgery no later than 8 weeks after randomization.
Peri-operative data will be collected. Clinical follow-up data will be collected at 1, 6 and 12 month after surgery. Graft patency at 12 months will be assessed by cardiac computed angiography (CCTA) for all patients who received at least one graft, except if an invasive coronary angiography has been performed in the preceding 3 months based on clinical grounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FFR-guided revascularization | Active comparator | Procedure: FFR-guided surgical revascularizationPatients with valvular heart disease scheduled for elective cardiac surgery and concomitant significant coronary artery disease will have FFR measured with a St. Jude Medical coronary pressure wire across all lesions in vessels pre-specified as suitable for surgical revascularization. If the FFR is ≤0.80, then CABG will be performed. If the FFR is >0.80 then no graft will be placed in that particular vessel. Patients in whom FFR of a particular lesion is not possible can be included if at least one additional lesion is suitable for FFR measurement and grafting. |
| Angio-guided revascularization | Active comparator | Procedure: Angio-guided surgical revascularizationConcomitant CABG will be performed as per clinical routine in all vessels with at least one stenosis > 50%. The vessel should be pre-specified as suitable for surgical revascularization before randomization. An internal mammary graft to the LAD should be attempted in all cases, if possible. Further revascularization strategy is left to the discretion of each center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Severe heart valve disease with indication for an elective cardiac with a St. Jude Medical Heart Valve
- Concomitant significant CAD (at least one epicardial vessel with a stenosis> 50%)
- Willing and able to provide informed written consent
Key exclusion criteria (10 listed)
- Previous CABG
- Angiographic significant lesion involving left main lesion (patient is still eligible if right coronary artery is candidate for FFR measurement and surgical revascularization)
- All lesions in extremely tortuous or calcified coronary vessels
- Recent myocardial infarction (< 30 days)
- Cardiogenic shock or clinical instability (i.e. NYHA 4, uncontrolled arrhythmias, unexplained hypotension severe bradycardia or any other medical condition considered as a sign of instability by the assisting physician)
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 |
|---|---|---|
| FFR-guided surgical revascularizationAlso: Fractional Flow Reserve-Guided surgical revascularization | Procedure or surgery | FFR-guided revascularization |
| Angio-guided surgical revascularizationAlso: Coronary artery bypass graft guided by angiographic-only assessment of severity stenosis | Procedure or surgery | Angio-guided revascularization |
Primary outcome
MACCE
Time frame: 12 months
Composite endpoint of death, nonfatal myocardial infarction, unplanned revascularization and stroke at 12 months. Subjects who die or are lost to follow up before 1 year will be censored at their last recorded activity.
Graft failure
Time frame: 12 months
Graft patency as assessed by CCTA scheduled at 12 months. Graft status can also be assessed by invasive coronary angiography if clinically indicated.
2 secondary outcomes
MACCE
Time frame: 1 month
MACCE
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
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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.
Mafalda Selas, RN contact
Ruben Ramos, MD principal investigator
Hospital Santa Marta, Centro Hospitalar Lisboa Central
Sergio Batista, MD principal investigator
Hospital Fernando da Fonseca
Luis Raposo, MD principal investigator
Hospital de Santa Cruz, Centro Hospitalar de Lisboa Central
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FFR-guided surgical revascularization and Angio-guided surgical revascularization in people with Coronary Artery Disease and Valvular Heart Disease, run by Portuguese Society of Cardiology at 1 site in Portugal.
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 4 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: status not confirmed, as of the sponsor's last update on 21 Oct 2016. 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruben Ramos, MD (+351963156910, ruben.a.b.ramos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACCE (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2016.