Whether to revascularize patients with angiographically-intermediate coronary lesions (AICL) is a major clinical issue. Intravascular techniques (assessing either the anatomy or the functional effect of coronary stenoses) are routinely used to better characterize coronary lesions. Among these,fractional flow reserve (FFR) provides validated functional insights while optical coherence tomography (OCT) provides high resolution anatomic imaging. Both techniques may be applied to guide decisions regarding the opportunity to revascularize patients with AICL and to optimize the result of percutaneous coronary intervention (PCI). We aim to compare the clinical and the economical impact of FFR versus OCT guidance in the percutaneous management of patients with AICL.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
FFR to assess coronary artery stenosis severity and indication to perform and eventually optimize percutaneous coronary intervention
OCT to assess coronary artery stenosis severity and indication to perform and eventually optimize percutaneous coronary intervention
Policlinico A. Gemelli. Università Cattolica del Sacro Cuore
Rome, Italy
RECRUITINGOccurrence of angina defined as Seattle Angina Questionnaire score < 90 in angina frequency scale, at 13 month follow up from index procedure*
\*In case of MACE rate absolute difference of \>1% between the two study arms, the primary end-point will be: "Occurrence of Major Cardiovascular Event and angina defined as Seattle Angina Questionnaire score \< 90 in angina frequency scale, at 13 months follow up from index procedure"
Time frame: 13 months
Occurrence of Major Cardiovascular Event and angina defined as Seattle Angina Questionnaire score < 90 in angina frequency scale, at 13 months follow up from index procedure
Time frame: 13 months
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