Computed Tomography Angiography Based Procedural Planning in PeRcutaneOus Coronary InterVEntion

Summary

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.

Conditions

• Coronary Arteries Disease
• Chronic Coronary Syndrome
• Acute Coronary Syndromes (ACS)
• Myocardial Ischemia
• Percutaneous Coronary Intervention
• Coronary Computed Tomography Angiography

Interventions

PROCEDURE

CCTA-Guided Percutaneous Coronary Intervention

Participants undergo percutaneous coronary intervention (PCI) guided by a structured coronary computed tomography angiography (CCTA)-based virtual procedural planning workflow. Pre-procedural centralized CCTA analysis provides information regarding lesion morphology, vessel dimensions, lesion length, calcium burden, bifurcation anatomy, optimal angiographic projections, and CT-derived fractional flow reserve to support procedural planning and PCI optimization.

PROCEDURE

Standard Percutaneous Coronary Intervention

Participants undergo PCI according to standard clinical practice and operator discretion without access to the advanced CCTA-derived virtual procedural planning. Operators may use intravascular imaging, physiological assessment, and adjunctive devices according to routine practice and guideline-based care.

Sponsors & Collaborators

• University of Galway

  lead OTHER

Principal Investigators

• Faisal Sharif, MBBS, PhD, FRCPI, FESC, FACC · University of Galway

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-18

Primary Completion

2028-05-20

Completion

2028-12-30