Post-Revascularization Optimization and PHysiological Evaluation of intermediaTe Lesions (NCT05056662) | Clinical Trial Compass
UnknownNot Applicable
Post-Revascularization Optimization and PHysiological Evaluation of intermediaTe Lesions
Italy1,000 participantsStarted 2020-06-04
Plain-language summary
PROPHET-FFR is a single center ambispective registry aiming to explore the impact of post-revascularization functional assessment on later outcomes.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* requiring coronary angiography to assess coronary artery disease;
* having at least one angiographically intermediate coronary stenosis (eg. 40%-80%) on any vessel requiring invasive functional assessment using FFR (and/or any other surrogate index)
* being able and legally entitled to give informed consent
Exclusion Criteria:
* history of severe poorly uncontrolled pulmonary disease
* hemodynamic instability during the diagnostic or therapeutic procedures;
* known adenosine intolerance
* need of mechanical circulatory or ventilatory support;
* stage IV chronic kidney disease.
* life expectancy \<1 year
* patients gaining indication to surgical revascularization;
* major procedural complications during percutaneous revascularization (cardiac arrest needing cardiopulmonary resuscitation, major bleeding , large iatrogenic coronary dissection, coronary embolization in a main vessel, suspected stroke) making post-PCI functional evaluation unsafe or impossible.
What they're measuring
1
Rate of composite of Major Adverse Cardiovascular Events (MACE) [ Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)]