Revascularization Versus Optimal Medical Therapy of Chronic Total Coronary Occlusions on Left Ventricular Ischemia Reduction

Inclusion criteria

• A chronic total occlusion is present and target lesion. A CTO is required to meet the following characteristics:

• A 100% luminal narrowing of the coronary artery without antegrade flow, i.e. Thrombolysis in Myocardial Infarction flow grade 0 or 1;
• Older than 3 months, established with previous PCI or with angiographic characteristics;
• Amenable to percutaneous revascularization.
• Patient has a clinical indication to perform CTO PCI.
• A SPECT is performed at baseline to assess ischemia and a cardiac magnetic resonance imaging (CMR) scan to assess viability, as part of routine patient care. Patients are deemed eligible for the randomized trial when they meet the ischemic threshold in the CTO territory.

The ischemic threshold is defined as:

• >12.5% of ischemia;
• With <50% transmural extent of infarction.
• Subject agrees to undergo follow-up SPECT-CT at 6 months after initial inclusion
• Subject is able to verbally confirm understanding and he/she provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee.

Exclusion criteria

• Subject is younger than 18 years of age;
• Persistent or permanent atrial fibrillation;
• Presence of a non-MRI compatible cardiac device, i.e. pacemaker or implantable cardioverter defibrillator;
• Body weight > 250 kg;
• Unable to exert, i.e. due to physical disability;
• Any contraindication for SPECT or CMR, i.e. cerebrovascular clips, claustrophobia;
• Known renal insufficiency (estimated Glomerular Filtration Rate [eGFR] <60 mL/min/1.73m2 or serum creatinine level of >2.5 mg/dL or subject on dialysis);
• Hypersensitivity or allergy to contrast with inability to properly pre-hydrate;
• Presence of a comorbid condition with a life expectancy of less than one year;
• Participation in another trial;
• Subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff) or is unable to read or write.