Severe and Symptomatic Aortic StenosisREVASC-TAVINCT02797158
Post TAVI Coronary REVASCularisation Guided by Myocardial Perfusion Imaging: a Prospective Open Label Pilot Study: The REVASC-TAVI Study
A study testing TAVI procedure in people with Severe and Symptomatic Aortic Stenosis and Stable Coronary Disease, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Evaluation of a strategy of selected revascularization guided on myocardial ischemia detection after the TAVI procedure by using single photon emission computed tomography (SPECT) myocardial perfusion imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe and Symptomatic Aortic Stenosis, Stable Coronary Disease
- What is being tested?
- TAVI procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jun 2016to 15 Jul 2019
- 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
- Patients older than 18 years
- Severe and symptomatic aortic stenosis defined as a median trans-valvular gradient higher than 40 mmHg and an aortic valve area of less than 1.0 cm2 or 0,6 cm2/m2 on echocardiography associated to significant CAD defined by ≥1 stenosis of ≥70% in a major epicardial coronary artery or ≥50% for left main
- Patients is not candidate for surgical aortic valve replacement after the multidisciplinary heart team decision.
Who cannot join
- Recent acute coronary syndrome (within 30 days before randomization),
- Unprotected left main disease
- Critical stenosis (>90%) of Left Anterior Descending artery (LAD),
- Significant angina (CCS class more than 2)
- Active bleeding,
- Contraindication for tomographic technetium-99 assessment or dipyridamole injection
- Previous enrollment in a other study
- Impossibly to obtain consent
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of a strategy of selected revascularization guided on myocardial ischemia detection after the TAVI procedure by using single photon emission computed tomography (SPECT) myocardial perfusion imaging.
Read the detailed description
Background: Percutaneous coronary intervention (PCI) is usually proposed to patients with aortic stenosis (AS) before TransAortic Valve Implantation (TAVI) when significant coronary stenosis is detected on preprocedural coronary angiography. However, the benefit of a systematic revascularisation is unknown and may have specific complications in elderly and frail patients.
Aims: The investigators proposed a strategy of selected revascularization guided on myocardial ischemia detection after the TAVI procedure by using single photon emission computed tomography (SPECT) myocardial perfusion imaging.
Methods: This prospective open label clinical trial will include 71 consecutive patients with significant coronary artery disease (CAD) defined by one or more significant coronary stenosis in patients admitted for TAVI. Myocardial SPECT imaging will be performed in all patients at 1-month follow-up after the TAVI procedure. Targeted PCI will be performed only in patients with significant related ischemia (> 10 % myocardial perfusion defect).
The primary outcome criterion is a composite criterion of feasibility and safety including all causes of death, stroke, major bleedings, major vascular complications, per procedural myocardial infarction, coronary revascularization or rehospitalisation for cardiac cause at 6 month follow-up.
Hypothesis: An alternative management of CAD guided by significant myocardial ischemia detection after TAVI could reduce the risk of unnecessary revascularization, the complications and the costs inherent to these procedures and a phase II trial is requiring to the evaluate this innovative and less invasive strategy.
- Being tested
- TAVI procedure
- Keywords
- TAVI, Aortic stenosis, Coronary artery disease, Coronary angiography, Percutaneous Coronary Intervention, Myocardial ischemia, SPECT, Coronary revascularization
- Medical subject headings
- Aortic Valve Stenosis, Coronary Artery Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVI procedureProcedure or surgery
Targeted and selected revascularization guided on myocardial ischemia detection after the TAVI procedure by using single photon emission computed tomography (SPECT) myocardial perfusion imaging.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Experimental | Not described Receives: Procedure: TAVI procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is a composite of all cause of death
Mortality is defined as death due to any cause, the exact nature and date of which will be recorded. All deaths will be considered cardiovascular-related unless there is documentation to the contrary.
Measured: 6 months
The primary endpoint is a composite of stroke
Measured: 6 months
The primary endpoint is a composite of major bleeding
Major bleedings are defined by ≥2 BARC classification.
Measured: 6 months
The primary endpoint is a composite of major vascular complication
Access site complications is defined in accordance with the Valve Academic Research Consortium (VARC) guidelines.
Measured: 6 months
The primary endpoint is a composite of periprocedural myocardial infarction
Perprocedural myocardial infarction is defined by 5-fold increased of basal troponin level associated to angina or ECG changes
Measured: 6 months
The primary endpoint is a composite of hospitalization for cardiac cause.
Measured: 6 months
Secondary outcomes (13)
Post-TAVI mortality
Measured: 1 and 6 months
Major adverse cardiovascular or cerebrovascular event (MACCE)
Measured: 1 and 6 months
Acute coronary syndrome (ACS)
Measured: 1 and 6 months
Acute myocardial infarction (MI)
Measured: 1 and 6 months
Rate of stroke
Measured: 1 and 6 months
Repeat revascularization by either PCI or CABG
Measured: 1 and 6 months
Hospitalization for heart failure or for non cardiovascular causes
Measured: 1 and 6 months
Duration of hospital stay
Measured: 1 and 6 months
Quality of life by Kansas city cardiomyopathy questionnaire
Measured: 1 and 6 months
Per-procedural complications
ventricular fibrillation (VF), ventricular tachycardia (VT) requiring cardioversion, cardiopulmonary arrest requiring cardiopulmonary resuscitation (CPR) and/or assisted mechanical respiratory support
Measured: 1 and 6 months
percentage of pacemaker after implantation of the valve
Measured: 1 and 6 months
Bleeding complications according to the BARC classification
Measured: 1 and 6 months
Severe VARC Access Site Complications (Safety Issue at 1 and 6 months)
Measured: 1 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study start23 Jun 2016
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe and Symptomatic Aortic StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence LECLERCQ, PU PH, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797158
- Sponsor's protocol ID
- RECHMPL15_0498
- Other IDs
- 2016-A00037-44
- Acronym
- REVASC-TAVI
- Status last verified
- May 2019
- First submitted
- 30 May 2016
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post TAVI Coronary REVASCularisation Guided by Myocardial Perfusion Imaging: a Prospective Open Label Pilot Study: The REVASC-TAVI Study
- ClinicalTrials.gov ID
- NCT02797158
- Acronym / sponsor ID
- REVASC-TAVI / RECHMPL15_0498
- Keywords
- TAVI, Aortic stenosis, Coronary artery disease, Coronary angiography, Percutaneous Coronary Intervention, Myocardial ischemia, SPECT, Coronary revascularization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 23 Jun 2016 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 13 Jun 2016 (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.
Evaluation of a strategy of selected revascularization guided on myocardial ischemia detection after the TAVI procedure by using single photon emission computed tomography (SPECT) myocardial perfusion imaging.
Detailed description
Background: Percutaneous coronary intervention (PCI) is usually proposed to patients with aortic stenosis (AS) before TransAortic Valve Implantation (TAVI) when significant coronary stenosis is detected on preprocedural coronary angiography. However, the benefit of a systematic revascularisation is unknown and may have specific complications in elderly and frail patients.
Aims: The investigators proposed a strategy of selected revascularization guided on myocardial ischemia detection after the TAVI procedure by using single photon emission computed tomography (SPECT) myocardial perfusion imaging.
Methods: This prospective open label clinical trial will include 71 consecutive patients with significant coronary artery disease (CAD) defined by one or more significant coronary stenosis in patients admitted for TAVI. Myocardial SPECT imaging will be performed in all patients at 1-month follow-up after the TAVI procedure. Targeted PCI will be performed only in patients with significant related ischemia (> 10 % myocardial perfusion defect).
The primary outcome criterion is a composite criterion of feasibility and safety including all causes of death, stroke, major bleedings, major vascular complications, per procedural myocardial infarction, coronary revascularization or rehospitalisation for cardiac cause at 6 month follow-up.
Hypothesis: An alternative management of CAD guided by significant myocardial ischemia detection after TAVI could reduce the risk of unnecessary revascularization, the complications and the costs inherent to these procedures and a phase II trial is requiring to the evaluate this innovative and less invasive strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Procedure: TAVI procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 18 years
- Severe and symptomatic aortic stenosis defined as a median trans-valvular gradient higher than 40 mmHg and an aortic valve area of less than 1.0 cm2 or 0,6 cm2/m2 on echocardiography associated to significant CAD defined by ≥1 stenosis of ≥70% in a major epicardial coronary artery or ≥50% for left main
- Patients is not candidate for surgical aortic valve replacement after the multidisciplinary heart team decision.
Key exclusion criteria (8 listed)
- Recent acute coronary syndrome (within 30 days before randomization),
- Unprotected left main disease
- Critical stenosis (>90%) of Left Anterior Descending artery (LAD),
- Significant angina (CCS class more than 2)
- Active bleeding,
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 |
|---|---|---|
| TAVI procedureTargeted and selected revascularization guided on myocardial ischemia detection after the TAVI procedure by using single photon emission computed tomography (SPECT) myocardial perfusion imaging. | Procedure or surgery | Interventional Arm |
Primary outcome
The primary endpoint is a composite of all cause of death
Time frame: 6 months
Mortality is defined as death due to any cause, the exact nature and date of which will be recorded. All deaths will be considered cardiovascular-related unless there is documentation to the contrary.
The primary endpoint is a composite of stroke
Time frame: 6 months
The primary endpoint is a composite of major bleeding
Time frame: 6 months
Major bleedings are defined by ≥2 BARC classification.
The primary endpoint is a composite of major vascular complication
Time frame: 6 months
Access site complications is defined in accordance with the Valve Academic Research Consortium (VARC) guidelines.
The primary endpoint is a composite of periprocedural myocardial infarction
Time frame: 6 months
Perprocedural myocardial infarction is defined by 5-fold increased of basal troponin level associated to angina or ECG changes
The primary endpoint is a composite of hospitalization for cardiac cause.
Time frame: 6 months
13 secondary outcomes
Post-TAVI mortality
Time frame: 1 and 6 months
Major adverse cardiovascular or cerebrovascular event (MACCE)
Time frame: 1 and 6 months
Acute coronary syndrome (ACS)
Time frame: 1 and 6 months
Acute myocardial infarction (MI)
Time frame: 1 and 6 months
Rate of stroke
Time frame: 1 and 6 months
Repeat revascularization by either PCI or CABG
Time frame: 1 and 6 months
Hospitalization for heart failure or for non cardiovascular causes
Time frame: 1 and 6 months
Duration of hospital stay
Time frame: 1 and 6 months
Quality of life by Kansas city cardiomyopathy questionnaire
Time frame: 1 and 6 months
Per-procedural complications
Time frame: 1 and 6 months
percentage of pacemaker after implantation of the valve
Time frame: 1 and 6 months
Bleeding complications according to the BARC classification
Time frame: 1 and 6 months
Severe VARC Access Site Complications (Safety Issue at 1 and 6 months)
Time frame: 1 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Severe and Symptomatic Aortic Stenosis
RecruitingObservational study
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
Enrolling by invitation
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
Aortic Valve Stenosis, Heart Valve Diseases
Not yet recruiting
Safety and Clinical Performance of the Next-Generation SAFESYNC Transcatheter Heart Valve in Patients With Severe Aortic Stenosis
Aortic Stenosis Senile, Aortic Stenosis Symptomatic
Recruiting
Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients
Aortic Stenosis
Recruiting
LANDMARK Trial: a Randomised Controlled Trial of Myval THV
Aortic Valve Stenosis
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.
Florence LECLERCQ, PU PH principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAVI procedure in people with Severe and Symptomatic Aortic Stenosis and Stable Coronary Disease, run by University Hospital, Montpellier at 1 site in France.
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 8 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 30 Sep 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary endpoint is a composite of all cause of death (time frame: 6 months). The study lists 6 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 30 Sep 2025.