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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; CT
• Intervention / Treatment: Procedure: CT-guided PCI; Procedure: Routine PCI

Detailed Description

CCTA provides comprehensive anatomical characterization of coronary arteries, including plaque morphology. It allows assessment of the origin and course of the coronaries, proximal and distal reference vessel dimensions, which can inform landing zones for stent length selection, and stent sizing. CCTA also enables comprehensive physiological assessment through fractional flow reserve (FFRCT), including FFRCT pullback for disease pattern characterization and delta FFRCT. In addition, CCTA can estimate vessel-specific myocardial mass to support bifurcation PCI planning and may assist intra-procedural guidance through CT co-registration. Whether CCTA-guided PCI is non-inferior to an intravascular ultrasound (IVUS) guided PCI strategy is being evaluated in the Precise Procedural and PCI Plan (P4) randomized clinical trial (NCT05253677). P4 enrolled approximately 1,100 patients and is evaluating the incidence of major adverse cardiovascular events (cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization) between CT- and IVUS-guided PCI at 12-months. While this landmark trial is expected to provide the first randomized data to support CT-guided PCI, broader clinical adoption remains limited by the need for multiple software platforms and investigational applications.

While promising, there are limited prospective and/or randomized data showing that CT-guided PCI is superior to standard of care. Early U.S. experience using coronary computed tomography angiography (CCTA) for percutaneous coronary intervention (PCI) planning highlighted the emerging role of CCTA to inform case complexity, equipment utilization, lesion morphology and non-invasive coronary physiology. Despite these promising findings, these studies were small, single-center, and non-controlled. To demonstrate clinical value, a randomized controlled trial comparing CCTA guided PCI with standard PCI would be necessary to determine whether this approach yields similar or superior outcomes in broader patient populations.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute Foundation
      • Principal Investigator: Yader Sandoval, MD
      • Contact: Olga Mastrodemos; Phone Number: 612-863-4768; Email: olga.mastrodemos@allina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CT-guided PCI; Pre-procedural planning will be completed using the participant's CT, and tools including Heartflow's PCI Navigator	Procedure: 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
Active Comparator: Routine PCI; Participants randomized to this arm will undergo standard-of-care PCI without pre-procedural planning based on CT	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural time	procedural time, defined as the time between the first to the final angiographic image acquisition	intra-procedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast volume	The volume of contrast used during the index procedure	intra-procedural
Radiation dose	The dose of radiation used during the index procedure	intra-procedural
Fluoroscopy time	The amount of time during the procedure that fluoroscopy was used	intra-procedural
Post-PCI pressure wire based FFR	Measured as a blinded investigational endpoint after the final angiographic image and not included in procedural time	intra-procedural
Use of advanced calcium modification techniques		intra-procedural
Resource utilization	number of diagnostic or guide catheters used, equipment usage throughout the case	intra-procedural
PCI Complications and Incidence of MACE During Index Procedure	incidence of major adverse cardiac events during the index procedure	intra-procedural
Peri-procedural myocardial injury and infarction	Incidence of myocardial injury and infarction after the index procedure, during hospitalization	Peri-procedural

Collaborators and Investigators

• Sponsor: Minneapolis Heart Institute Foundation
• Collaborators: Shockwave Medical, Inc.; HeartFlow, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): July 15, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: June 30, 2026
• First Submitted That Met QC Criteria: June 30, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: 2436925-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No