Computed Tomography Angiography Based Procedural Planning in PeRcutaneOus Coronary InterVEntion

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Galway

About this trial

The goal of this clinical trial is to learn whether coronary CT angiography (CCTA)-guided planning improves the efficiency and outcomes of percutaneous coronary intervention (PCI) in adults with coronary artery disease. It will also evaluate the feasibility and safety of using a CT-based "virtual PCI plan" during coronary interventions.

The main questions it aims to answer are:

* Does CCTA-guided PCI reduce procedural time, radiation exposure, and contrast dye use compared with standard PCI? * Does CCTA-guided PCI improve procedural outcomes and stent optimization? * How often do operators follow or deviate from the CT-based procedural plan? * What medical problems or complications occur during and after CCTA-guided PCI?

Researchers will compare CCTA-guided PCI with standard angiography-guided PCI to determine whether CT-derived procedural planning improves PCI efficiency and clinical outcomes.

Participants will:

* Undergo PCI guided either by a CCTA-based virtual planning strategy or by standard clinical practice * Attend follow-up assessments at 1 month, 6 months, and 1 year * Undergo routine clinical evaluations and imaging assessments related to their PCI procedure * Be monitored for procedural complications, symptoms, repeat procedures, and cardiovascular outcomes during follow-up

The study will also include a parallel observational registry for patients whose coronary lesions are deferred from PCI, to evaluate their long-term clinical outcomes.

Eligibility criteria

Qualifiers

Adults aged 18 to 80 years

Ability to provide written informed consent

Patients undergoing coronary computed tomography angiography (CCTA) for suspected coronary artery disease or for diagnostic work-up of stabilized acute coronary syndrome

CT-derived fractional flow reserve (CT-FFR) ≤0.80

Disqualifiers

Contraindication to iodinated contrast media, including severe allergy or contrast-induced nephropathy

Poor-quality or non-diagnostic CCTA imaging

Target lesions involving in-stent restenosis

Chronic total occlusion target lesions

Trial design

Treatments tested in this trial

  • CCTA-Guided Percutaneous Coronary Intervention
  • Standard Percutaneous Coronary Intervention

Treatment groups

200 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators