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Table 2 Inclusion and exclusion criteria

From: Fractional flow reserve or optical coherence tomography guidance to revascularize intermediate coronary stenosis using angioplasty (FORZA) trial: study protocol for a randomized controlled trial

Inclusion criteria

Exclusion criteria

Clinical

Clinical

Age >18 years

Age <18 years

Diagnosis of ischemic heart disease

Inability to give informed consent

 

Female with child-bearing potential

Angiographic

Life expectancy <12 months

Single vessel disease with angiographically intermediate coronary lesion OR

Factors making clinical follow up difficult (such as no fixed address)

Multivessel disease with only angiographically intermediate coronary lesion OR

Poor cardiac function as defined by left ventricular global ejection fraction ≤30%

Multivessel disease with at least one angiographically intermediate coronary lesion and already treated angiographically critical stenosis

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 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 the four weeks previous

 

History of clotting pathology

 

Known hypersensitivity to aspirin, heparin, or contrast dye

 

Advanced renal failure with a glomerular filtration rate <30 ml/min

 

Angiographic

 

Multivessel disease with one or more untreated angiographically critical stenosis or coronary occlusion.

 

Lesions in coronary artery bypass grafts

 

Multivessel disease requiring coronary aortic bypass graft intervention