About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Multivessel CAD involving ≥3 vessels.
Severe left main disease >50%
Prior CABG
Prior PCI in target vessel
Trial design
Treatments tested in this trial
- CT-guided PCI
- Routine PCI
Treatment groups
Sponsors and collaborators
Minneapolis Heart Institute Foundation
Lead sponsor
HeartFlow, Inc.
Collaborator
Shockwave Medical, Inc.
Collaborator