Coronary Artery Disease, CT
Conditions
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.
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.
Interventions
PROCEDURECT-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
PROCEDURERoutine 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.
Sponsors
Minneapolis Heart Institute Foundation
HeartFlow, Inc.
Shockwave Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural time | intra-procedural | procedural time, defined as the time between the first to the final angiographic image acquisition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contrast volume | intra-procedural | The volume of contrast used during the index procedure |
| Radiation dose | intra-procedural | The dose of radiation used during the index procedure |
| Fluoroscopy time | intra-procedural | The amount of time during the procedure that fluoroscopy was used |
| Post-PCI pressure wire based FFR | intra-procedural | Measured as a blinded investigational endpoint after the final angiographic image and not included in procedural time |
| Use of advanced calcium modification techniques | intra-procedural | — |
| Resource utilization | intra-procedural | number of diagnostic or guide catheters used, equipment usage throughout the case |
| PCI Complications and Incidence of MACE During Index Procedure | intra-procedural | incidence of major adverse cardiac events during the index procedure |
| Peri-procedural myocardial injury and infarction | Peri-procedural | Incidence of myocardial injury and infarction after the index procedure, during hospitalization |
Countries
United States
Outcome results
None listed