Coronary Artery DiseaseCT-PLAN-PCINCT07691502
Coronary Computed Tomography Angiography (CCTA) for the Pre-procedural Planning of Percutaneous Coronary Intervention
A study testing CT-guided PCI and Routine PCI in people with Coronary Artery Disease and CT, run by Minneapolis Heart Institute Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Coronary Artery Disease, CT
- What is being tested?
- CT-guided PCI and Routine PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Olga Mastrodemos, 612-863-4768, olga.mastrodemos@allina.com
Yader Sandoval, MD
About this study
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
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.
Read the 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.
- Conditions
- Coronary Artery Disease, CT
- Being tested
- CT-guided PCI, Routine PCI
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-guided PCIProcedure or surgery
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 PCIProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| CT-guided PCI | Experimental | Pre-procedural planning will be completed using the participant's CT, and tools including Heartflow's PCI Navigator Receives: 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 Receives: Procedure: Routine PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural time
procedural time, defined as the time between the first to the final angiographic image acquisition
Measured: intra-procedural
Secondary outcomes (8)
Contrast volume
The volume of contrast used during the index procedure
Measured: intra-procedural
Radiation dose
The dose of radiation used during the index procedure
Measured: intra-procedural
Fluoroscopy time
The amount of time during the procedure that fluoroscopy was used
Measured: 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
Measured: intra-procedural
Use of advanced calcium modification techniques
Measured: intra-procedural
Resource utilization
number of diagnostic or guide catheters used, equipment usage throughout the case
Measured: intra-procedural
PCI Complications and Incidence of MACE During Index Procedure
incidence of major adverse cardiac events during the index procedure
Measured: intra-procedural
Peri-procedural myocardial injury and infarction
Incidence of myocardial injury and infarction after the index procedure, during hospitalization
Measured: Peri-procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start31 Aug 2026 (estimated)
- Primary completion15 Jul 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minneapolis Heart Institute Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- HeartFlow, Inc., Shockwave Medical, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691502
- Sponsor's protocol ID
- 2436925-1
- Acronym
- CT-PLAN-PCI
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07691502
- Acronym / sponsor ID
- CT-PLAN-PCI / 2436925-1
- Conditions
- Coronary Artery Disease, CT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Minneapolis Heart Institute FoundationUniversity, hospital or other
- Collaborators
- HeartFlow, Inc., Shockwave Medical, Inc.
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 15 Jul 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-guided PCI | Experimental | Procedure: CT-guided PCIPre-procedural planning will be completed using the participant's CT, and tools including Heartflow's PCI Navigator |
| Routine PCI | Active comparator | Procedure: Routine PCIParticipants randomized to this arm will undergo standard-of-care PCI without pre-procedural planning based on CT |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (13 listed)
- Multivessel CAD involving ≥3 vessels.
- Severe left main disease >50%
- Prior CABG
- Prior PCI in target vessel
- Planned CABG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-guided PCIParticipants 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 | Procedure or surgery | CT-guided PCI |
| Routine PCIParticipants 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. | Procedure or surgery | Routine PCI |
Primary outcome
Procedural time
Time frame: intra-procedural
procedural time, defined as the time between the first to the final angiographic image acquisition
8 secondary outcomes
Contrast volume
Time frame: intra-procedural
Radiation dose
Time frame: intra-procedural
Fluoroscopy time
Time frame: intra-procedural
Post-PCI pressure wire based FFR
Time frame: intra-procedural
Use of advanced calcium modification techniques
Time frame: intra-procedural
Resource utilization
Time frame: intra-procedural
PCI Complications and Incidence of MACE During Index Procedure
Time frame: intra-procedural
Peri-procedural myocardial injury and infarction
Time frame: Peri-procedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Minneapolis Heart Institute Foundation
Minneapolis, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-guided PCI and Routine PCI in people with Coronary Artery Disease and CT, run by Minneapolis Heart Institute Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural time (time frame: intra-procedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.