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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Minneapolis Heart Institute Foundation
Study ID
NCT07691502
Status
Not Yet Recruiting

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Conditions

  • CT
  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CT-guided PCI — PROCEDURE
    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 — PROCEDURE
    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.

Study Details

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.

Key Dates

First listed
Jul 9, 2026
Start date
Jul 15, 2026
Status verified
Jun 2026
Primary completion
Jul 15, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Procedural time [ Time Frame: intra-procedural ]

Locations (1)

FacilityCityStateZIPSite coordinators
Minneapolis Heart Institute FoundationMinneapolisMinnesota55407
Olga Mastrodemos
[email protected]
612-863-4768
Yader Sandoval, MD (PRINCIPAL_INVESTIGATOR)

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Minneapolis Heart Institute Foundation· Minneapolis, MN

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