Clinical trial Recruiting at 1 site Interventional Ages 22 and up

CT-guided planning for PCI to see if it helps procedures

Official title: Coronary Computed Tomography Angiography (CCTA) for the Pre-procedural Planning of Percutaneous Coronary Intervention: A Randomized Trial of Routine PCI Versus CCTA-guided PCI

Run by Minneapolis Heart Institute Foundation · NCT07691502 · Data updated 2026-11-12

Doctors will test whether planning PCI with CT angiography helps the procedure go more smoothly for people with coronary artery disease.

Quick facts

Study typeInterventional
Ages22 Years and up
SexAll
Enrollment200 (estimated)
SponsorMinneapolis Heart Institute Foundation
Academic / other
Drugs / interventionsradiation
Locations1 site (Minneapolis, Minnesota)
StatusRecruiting
StartedAugust 31, 2026
Main results expectedJuly 15, 2028
Study endsDecember 1, 2028
Registry record updatedAugust 27, 2026
Trial IDNCT07691502 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with at least one de novo moderate-to-severe native coronary stenosis who are referred for non-emergent PCI and have FFRCT-eligible lesions on CCTA.

Probably not a fit

Patients with multivessel disease beyond two target vessels, severe left main disease, prior CABG or PCI in the target vessel, or conditions that preclude FFRCT may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial compares PCI planning using CT angiography guidance versus routine PCI planning without CCTA guidance. The main outcome is procedural time, with secondary measures including contrast volume, radiation exposure, fluoroscopy time, resource use, and peri-procedural biomarkers of injury. The study uses CCTA to characterize anatomy, assess plaque morphology, and estimate stent sizing, and may incorporate FFRCT-based assessments and co-registration to guide the procedure. Results will be interpreted in the context of prior research, including trials comparing CT-guided and IVUS-guided PCI, as evidence evolves for broader adoption.

Why it matters

Potential benefit: If successful, CT-guided PCI planning could reduce procedure time and exposure while improving planning accuracy.

How similar studies have gone: Prior randomized data (P4 trial) and emerging experiences suggest potential benefits of CT-guided approaches, but broader, definitive evidence is still being established.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Minneapolis Heart Institute Foundation
    Minneapolis, Minnesota, United States
    Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.