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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)

30. juni 2026 opdateret af: Minneapolis Heart Institute Foundation
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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Minneapolis Heart Institute Foundation
        • Ledende efterforsker:
          • Yader Sandoval, MD
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Aktiv komparator: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procedural time
Tidsramme: intra-procedural
procedural time, defined as the time between the first to the final angiographic image acquisition
intra-procedural

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Contrast volume
Tidsramme: intra-procedural
The volume of contrast used during the index procedure
intra-procedural
Radiation dose
Tidsramme: intra-procedural
The dose of radiation used during the index procedure
intra-procedural
Fluoroscopy time
Tidsramme: intra-procedural
The amount of time during the procedure that fluoroscopy was used
intra-procedural
Post-PCI pressure wire based FFR
Tidsramme: intra-procedural
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
Tidsramme: intra-procedural
intra-procedural
Resource utilization
Tidsramme: intra-procedural
number of diagnostic or guide catheters used, equipment usage throughout the case
intra-procedural
PCI Complications and Incidence of MACE During Index Procedure
Tidsramme: intra-procedural
incidence of major adverse cardiac events during the index procedure
intra-procedural
Peri-procedural myocardial injury and infarction
Tidsramme: Peri-procedural
Incidence of myocardial injury and infarction after the index procedure, during hospitalization
Peri-procedural

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Minneapolis Heart Institute Foundation

Samarbejdspartnere

Shockwave Medical, Inc.
HeartFlow, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juli 2026

Primær færdiggørelse (Anslået)

15. juli 2028

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

30. juni 2026

Først indsendt, der opfyldte QC-kriterier

30. juni 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2436925-1

Plan for individuelle deltagerdata (IPD)

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