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.
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.
Multivessel CAD involving ≥3 vessels.
Severe left main disease >50%
Prior CABG
Prior PCI in target vessel
Parallel
CT-guided PCI
Procedure/SurgeryParticipants randomized to CT-guided PCI will have their clinically available CCTAs analyzed using commercially available software to create a pre-procedural plan, which will be used to help guide the procedure
Routine PCI
Procedure/SurgeryParticipants randomized to routine PCI will not have their CCTA's analyzed pre-procedure. The investigator may use intravascular imaging and pre-PCI FFR, but these are not mandated. The investigator will use the information obtained from the coronary angiogram to treat any coronary artery disease that is present.
Procedural time
procedural time, defined as the time between the first to the final angiographic image acquisition
Contrast volume
The volume of contrast used during the index procedure
Radiation dose
The dose of radiation used during the index procedure
Fluoroscopy time
The amount of time during the procedure that fluoroscopy was used
Post-PCI pressure wire based FFR
Measured as a blinded investigational endpoint after the final angiographic image and not included in procedural time
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Minneapolis Heart Institute Foundation
Lead sponsor
HeartFlow, Inc.
Collaborator
Shockwave Medical, Inc.
Collaborator
