FFR or OCT Guidance to RevasculariZe Intermediate Coronary Stenosis Using Angioplasty (FORZA)

Catholic University of the Sacred Heart

Status and phase: Unknown; Phase 3

Conditions: Ischemic Heart Disease

Treatments: Device: FFR guided PCI; Device: OCT guided PCI

Study type: Interventional

Funder types: Other

Identifiers

NCT01824030

6261/13

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

FFR guided PCI arm

Active Comparator group

Description:

Patients with angiographic intermediate coronary artery stenosis randomized to FFR assessment. PCI performed only if FFR ≤ 0.80

Treatment:

Device: FFR guided PCI

OCT guided PCI arm

Active Comparator group

Description:

Patients with angiographic intermediate coronary artery stenosis randomized to OCT. PCI will be performed if: 1. percentage area stenosis ≥75 % 2. percentage area stenosis between 50 and 75% and minimal lumen area \<2.5 mm2 3. percentage area stenosis between 50 and 75% and major plaque ulceration

Treatment:

Device: OCT guided PCI