Coronary Computed Tomography Angiography (CCTA) for the Pre-procedural Planning of Percutaneous Coronary Intervention
NCT07691502
Summary
The CT-PLAN PCI trial will evaluate whether CCTA-guided PCI improves procedural efficiency compared with routine PCI (without pre-procedural CCTA-guidance for PCI planning) using procedural time as the primary endpoint. Key secondary outcomes will include contrast volume, radiation dose, fluoroscopy time, resource utilization, and periprocedural outcomes including post-PCI physiology, and peri-procedural myocardial injury measured by high-sensitivity cardiac troponin assays.
Eligibility
Inclusion Criteria: * At least one moderate-severe coronary stenosis on CCTA with an FFRCT ≤0.80 involving no more than two vessels (i.e. target lesion(s) must be FFRCT eligible) * Referral for non-emergent PCI of at least one de novo stenosis in a native coronary artery with a reference diameter ≥2 mm on CCTA. Exclusion Criteria: * Multivessel CAD involving ≥3 vessels. * Severe left main disease \>50% * Prior CABG * Prior PCI in target vessel * Planned CABG * Chronic coronary total occlusion in the target vessel * ST-elevation myocardial infarction * Emergent PCI * Cardiac arrest * Cardiogenic shock * Scenarios where FFRCT is not possible: inadequate CCTA quality for FFRCT, small vessels \<2 mm, with stents at the target vessel. * Unstable high-risk NSTE-ACS (hemodynamic instability, refractory angina, unstable arrhythmias, persistent ischemia). * Patients who are pregnant or nursing or plan to be pregnant in the period up to 2 years following the index procedure will not be approached due to exposure to fluoroscopy.
Conditions3
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NCT07691502