Clinical trial NCT01824030: FFR or OCT Guidance to RevasculariZe Intermediate Coronary Stenosis Using Angioplasty
Official title: FFR or OCT Guidance to RevasculariZe Intermediate Coronary Stenosis Using Angioplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ischemic Heart Disease
Keywords: FFR, OCT, Seattle Angina Questionnaire
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of angina defined as Seattle Angina Questionnaire score < 90 in angina frequency scale, at 13 month follow up from index procedure*
timeFrame: 13 months
Secondary outcomes:
measure: 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
timeFrame: 13 months
Other outcomes:
measure: Periprocedural costs
timeFrame: 30 days
measure: Periprocedural costs
timeFrame: 13 months
Locations:
city: Rome
country: Italy
facility: Policlinico A. Gemelli. Università Cattolica del Sacro Cuore
Study officials:
affiliation: Università Cattolica del Sacro Cuore, Roma
name: Francesco Burzotta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burzotta F, Leone AM, Aurigemma C, Zambrano A, Zimbardo G, Arioti M, Vergallo R, De Maria GL, Cerracchio E, Romagnoli E, Trani C, Crea F. Fractional Flow Reserve or Optical Coherence Tomography to Guide Management of Angiographically Intermediate Coronary Stenosis: A Single-Center Trial. JACC Cardiovasc Interv. 2020 Jan 13;13(1):49-58. doi: 10.1016/j.jcin.2019.09.034.
citation: Leone AM, Burzotta F, Aurigemma C, De Maria GL, Zambrano A, Zimbardo G, Arioti M, Cerracchio E, Vergallo R, Trani C, Crea F. Prospective Randomized Comparison of Fractional Flow Reserve Versus Optical Coherence Tomography to Guide Revascularization of Intermediate Coronary Stenoses: One-Month Results. J Am Heart Assoc. 2019 Aug 6;8(15):e012772. doi: 10.1161/JAHA.119.012772. Epub 2019 Jul 23.
citation: Burzotta F, Leone AM, De Maria GL, Niccoli G, Coluccia V, Pirozzolo G, Saffioti S, Aurigemma C, Trani C, Crea F. Fractional flow reserve or optical coherence tomography guidance to revascularize intermediate coronary stenosis using angioplasty (FORZA) trial: study protocol for a randomized controlled trial. Trials. 2014 Apr 23;15:140. doi: 10.1186/1745-6215-15-140.