Ischemic Heart Disease
Conditions
Keywords
FFR, OCT, Seattle Angina Questionnaire
Brief summary
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.
Interventions
DEVICEFFR guided PCI
FFR to assess coronary artery stenosis severity and indication to perform and eventually optimize percutaneous coronary intervention
DEVICEOCT guided PCI
OCT to assess coronary artery stenosis severity and indication to perform and eventually optimize percutaneous coronary intervention
Sponsors
Catholic University of the Sacred Heart
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* single vessel disease with an intermediate coronary artery stenosis * multivessel disease with multiple intermediate coronary artery stenosis only * multivessel disease with already treated angiographically critical stenosis and at least one intermediate coronary artery stenosis
Exclusion criteria
* age \<18 years or impossibility to give informed consent, * female sex with child-bearing potential, * life expectancy of less than 12 months or factors making clinical follow-up difficult (no fixed address, etc), * poor cardiac function as defined by left ventricular global ejection fraction ≤ 30% * recent (\< 7 days) ST-segment elevation myocardial infarction * recent (\< 48 hours) Non ST-segment elevation myocardial infarction * prior ST-segment elevation myocardial infarction in the territory supplied by the vessel with the intermediate stenosis under investigation * severe myocardial hypertrophy (interventricular septum thickness \> 15 mm, ECG Sokolow's criteria fulfilled) * severe valvular heart disease * significant platelet count alteration (\<100,000 cells/mm3 or \> 700,000 cells/mm3) * gastrointestinal bleeding requiring surgery or blood transfusions within 4 previous weeks * history of clotting pathology * known hypersensitivity to aspirin, heparin, contrast dye * advance renal failure with glomerular filtration rate \< 30 ml/min * lesions in coronary artery bypass grafts * multivessel disease requiring coronary aortic bypass graft intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of angina defined as Seattle Angina Questionnaire score < 90 in angina frequency scale, at 13 month follow up from index procedure* | 13 months | \*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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 13 months |
Other
| Measure | Time frame |
|---|---|
| Periprocedural costs | 30 days |
Countries
Italy
Contacts
Primary ContactFrancesco Burzotta, MD, PhD
Outcome results
None listed