What this study is
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.
What's being tested
- CT-guided PCI
Intervention · 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
Intervention · 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
- 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
- Sponsor
- Minneapolis Heart Institute Foundation
- Conditions
- Coronary Artery Disease · CT
- Enrolling
- 200 people
- Starts
- 2026-08-31
- Est. completion
- 2028-12-01
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 22 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMinneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
- Olga Mastrodemos · Contact612-863-4768olga.mastrodemos@allina.com
- Yader Sandoval, MD · Principal investigator
Recruiting
Study team
Sponsor
Minneapolis Heart Institute Foundation
Study ID 2436925-1
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.