Recruiting

CCTA Guided PCI

Sponsor:

Minneapolis Heart Institute Foundation

Code:

NCT07691502

Conditions

Coronary Artery Disease

CT

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

CT-guided PCI

Routine PCI

Study Details

Brief 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.

Conditions

Coronary Artery Disease

CT

Study ID

NCT07691502

Start date

Aug 31, 2026

Status verified date

Jul, 2026

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Jul 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CT-guided PCI

Pre-procedural planning will be completed using the participant's CT, and tools including Heartflow's PCI Navigator

active comparator: Routine PCI

Participants randomized to this arm will undergo standard-of-care PCI without pre-procedural planning based on CT

Interventions

CT-guided PCI

Participants 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

Participants 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.

Primary outcome measure

  • Procedural time [ Time Frame: intra-procedural ]

Central Contacts and Locations

Locations

Minneapolis Heart Institute Foundation

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Olga Mastrodemos

612-863-4768olga.mastrodemos@allina.com

Principal Investigator:

Yader Sandoval, MD

More Information

Sponsor

Minneapolis Heart Institute Foundation

Last update posted

Aug 27, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Minneapolis Heart Institute Foundation on 2026-08-27.