Coronary Computed Tomography Angiography (CCTA) for the Pre-procedural Planning of Percutaneous Coronary Intervention

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorMinneapolis Heart Institute Foundation

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

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Minneapolis Heart Institute Foundation

Lead sponsor

HeartFlow, Inc.

Collaborator

Shockwave Medical, Inc.

Collaborator