Post TAVI Coronary REVASCularisation Guided by Myocardial Perfusion Imaging: a Prospective Open Label Pilot Study: The REVASC-TAVI Study
NCT ID: NCT02797158
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
71 participants
INTERVENTIONAL
2016-06-23
2019-07-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Interventional Arm
TAVI procedure
Targeted and selected revascularization guided on myocardial ischemia detection after the TAVI procedure by using single photon emission computed tomography (SPECT) myocardial perfusion imaging.
Interventions
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TAVI procedure
Targeted and selected revascularization guided on myocardial ischemia detection after the TAVI procedure by using single photon emission computed tomography (SPECT) myocardial perfusion imaging.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Florence LECLERCQ, PU PH
Role: PRINCIPAL_INVESTIGATOR
Montpellier University Hospital
Locations
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Montpellier University Hospital
Montpellier, , France
Countries
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Other Identifiers
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2016-A00037-44
Identifier Type: REGISTRY
Identifier Source: secondary_id
RECHMPL15_0498
Identifier Type: -
Identifier Source: org_study_id
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