CT-Guided PCI for Coronary Artery Disease
(CT-PLAN-PCI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults with coronary artery disease who are scheduled to have a procedure called PCI (angioplasty) to open blocked heart arteries. People with certain health conditions or risks that could interfere with the study may not be able to join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-procedural Planning
Pre-procedural planning using CCTA for PCI, including assessment of coronary anatomy and stent planning
Treatment
Participants undergo PCI, either CCTA-guided or routine, with procedural time as the primary endpoint
Follow-up
Participants are monitored for safety and effectiveness, including incidence of major adverse cardiovascular events
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares two ways of planning PCI: one group gets a special heart CT scan (CCTA) before their procedure, while the other group has routine care without this scan. The main goal is to see if using CCTA makes the procedure faster and more efficient.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Pre-procedural planning will be completed using the participant's CT, and tools including Heartflow's PCI Navigator
Participants randomized to this arm will undergo standard-of-care PCI without pre-procedural planning based on CT
Find a Clinic Near You
Who Is Running the Clinical Trial?
Minneapolis Heart Institute Foundation
Lead Sponsor
HeartFlow, Inc.
Industry Sponsor
Shockwave Medical, Inc.
Industry Sponsor
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