NCT07691502

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
28mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jul 2026Dec 2028

First Submitted

Initial submission to the registry

June 30, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

July 15, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

June 30, 2026

Last Update Submit

July 8, 2026

Conditions

Coronary Artery DiseaseCT

Outcome Measures

Primary Outcomes (1)

  • Procedural time

    procedural time, defined as the time between the first to the final angiographic image acquisition

    intra-procedural

Secondary Outcomes (8)

  • Contrast volume

    intra-procedural

  • Radiation dose

    intra-procedural

  • Fluoroscopy time

    intra-procedural

  • Post-PCI pressure wire based FFR

    intra-procedural

  • Use of advanced calcium modification techniques

    intra-procedural

  • +3 more secondary outcomes

Study Arms (2)

CT-guided PCI

EXPERIMENTAL

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

Procedure: CT-guided PCI

Routine PCI

ACTIVE COMPARATOR

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

Procedure: Routine PCI

Interventions

CT-guided PCIPROCEDURE

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

CT-guided PCI
Routine PCIPROCEDURE

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.

Routine PCI

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 9, 2026

Study Start

July 15, 2026

Primary Completion (Estimated)

July 15, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

July 10, 2026

Record last verified: 2026-07

Locations

US(1)