Optical Coherence Tomography-guided Coronary Intervention and Optimal Use of Dual Anti-Platelet Therapy In Patients With Complex Lesions (OCCUPI Trial)

• Status: Not yet recruiting
• Trial end date: 2022-11-30
• Target enrollment: 2880
• Participant gender: All

Summary

There is no definite conclusive work about optimal duration of DAPT after PCI of complex lesions, which have been left at each operator's discretion. It is needed to be investigated how optimal duration of dual antiplatelet therapy will be decided in complex lesions. Also, the benefit of OCT-guided PCI assuming better stent optimization should be determined in complex PCI. In the study, we will explore the clinical implication of OCT-guided PCI of complex lesions. Optimal duration of DAPT after PCI of complex lesions with or without OCT-guidance will be also investigated.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University

Criteria

Inclusion Criteria:

• Age 19-85 years

• Patients with ischemic heart disease presented with typical chest pain or suspected evidences of myocardial ischemia (positive non-invasive study or electrocardiogram (ECG) consistent with ischemia)

• Patients who provide signed informed consent

• Coronary stenosis considered for coronary revascularization with stent implantation

• Angiographic ≥70% diameter stenosis of major epicardial arteries or ≥50% diameter stenosis of left main coronary artery or intermediate stenosis (50-69% diameter stenosis) with functional significance determined by fractional flow reserve <0.8

• Any of complex lesion characteristics: Chronic total occlusion, Long lesion: expected stent length ≥28mm based on angiographic estimation, Calcified lesion (including indication of rotablator atherectomy), Bifurcation, Unprotected left main disease, Small vessel with reference vessel diameter less than 2.5 mm, Intracoronary thrombus visible by angiography

Exclusion Criteria:

• Acute myocardial infarction (STEMI or NSTEMI) within 3 months

• Left main bifurcation lesion requiring elective two-stent strategy

• Contraindication for antiplatelet agents and bleeding history within 3 months

• Prior history of the following presentations: Cerebral vascular accidents (except transient ischemic attack), Thromboembolic disease, Stent thrombosis

• Need of prolonged anticoagulation more than 1 month with any reasons (e.g. atrial fibrillation)

• Known hypersensitivity, contraindication to iodine-containing contrast media, heparin, aspirin, clopidogrel, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoropolymers

• Concomitant treatment with strong CYP3A inducers (rifampicin, phenytoin, carbamazepine, dexamethasone, phenobarbital) or inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir) within 14 days and during study treatment

• Solid organ transplantation recipient or subject on a waiting list

• Receiving immunosuppressant therapy or known immunosuppressive or autoimmune disease

• Severe hepatic dysfunction (≥3 times normal reference values)

• Significant renal dysfunction (Serum creatinine >2.0 mg/dL)

• Platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a white blood cell count of <3,000 cells/mm3, hemoglobin <8.0 g/dL, or other known bleeding diathesis

• Cardiogenic shock

• Left ventricular ejection fraction <30%

• Pregnant women or women who might be pregnant

• Life expectancy; less than 1 year

• Inability to understand or read the informed content