Computed Tomography Angiography Based Procedural Planning in PeRcutaneOus Coronary InterVEntion

NCT07592312 | Not Yet Recruiting DMC

• 1 other identifier: MNA0805
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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

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

Keywords

Coronary Artery Disease; Chronic Coronary Disease; Percutaneous Coronary Intervention; Coronary Computed Tomography Angiography

Outcome Measures

Primary Outcomes (4)

• Radiation dose during PCI

  Radiation exposure during the invasive PCI procedure will be compared between the CCTA-guided PCI group and the standard PCI group. Radiation exposure will be quantified using dose-area product (DAP) or cumulative radiation dose recorded during the procedure.

  During index PCI procedure

• Procedural time

  Procedural time will be compared between the CCTA-guided PCI and standard PCI groups. Procedural time is defined as the interval between initial insertion of the guiding catheter into the arterial sheath and the final angiographic image.

  During index PCI procedure

• Contrast volume used during PCI

  Contrast volume used during the invasive PCI procedure will be compared between study groups. Contrast volume will be measured in millilitres and used to assess the impact of CCTA-guided planning on contrast utilization compared with standard PCI.

  During index PCI procedure

• Deviation rate from CCTA-based virtual PCI planning

  Feasibility will be assessed by recording the absolute number of deviations and relative deviation rate from the recommended CCTA-based virtual PCI planning steps. Deviations may include technical issues, clinically justified operator decisions, or unjustified deviations from the recommended plan. An overall deviation rate exceeding 10% will be considered clinically relevant.

  During index PCI procedure

Secondary Outcomes (12)

• Agreement between CCTA-based virtual PCI planning and operator standard planning

  During index PCI procedure

• Vessel-Oriented Procedural Outcome

  During index PCI procedure

• Final minimal stent diameter

  Immediately after index PCI procedure

• Degree of functional revascularization

  Immediately after index PCI procedure

• Maximum device size/reference vessel diameter ratio

  During index PCI procedure

Study Arms (2)

CCTA-Guided PCI

EXPERIMENTAL

Participants randomized to this arm will undergo percutaneous coronary intervention (PCI) guided by a structured coronary computed tomography angiography (CCTA)-based virtual procedural planning strategy. Pre-procedural centralized CCTA analysis will provide information regarding lesion morphology, vessel dimensions, lesion length, calcium distribution, bifurcation anatomy, optimal angiographic projections, and CT-derived functional assessment. Operators will use this information during PCI planning and execution to guide lesion preparation, device selection, stent sizing, and procedural strategy.

Procedure: CCTA-Guided Percutaneous Coronary Intervention

Standard PCI

ACTIVE COMPARATOR

Participants randomized to this arm will undergo PCI according to standard clinical practice and operator discretion without access to the advanced CCTA-derived virtual procedural planning. Operators may use additional intravascular imaging, physiological assessment, or adjunctive devices according to routine practice. The CCTA-based procedural planning generated by the core laboratory will remain concealed from operators throughout the procedure.

Procedure: Standard Percutaneous Coronary Intervention

Interventions

CCTA-Guided Percutaneous Coronary Intervention PROCEDURE

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.

CCTA-Guided PCI

Standard Percutaneous Coronary Intervention PROCEDURE

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.

Standard PCI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Presence of at least one target coronary lesion meeting one of the following CCTA criteria:
• Severe coronary diameter stenosis (70-99%) in one or more coronary arteries according to CAD-RADS 4A or 4B classification and at least one of the following:
• CT-derived fractional flow reserve (CT-FFR) ≤0.80
• At least 2 high-risk plaque characteristics, including:
• Low attenuation plaque density \<30 Hounsfield units
• Positive remodeling index \>1.1
• Napkin-ring sign
• Spotty calcification
• Left main coronary artery stenosis ≥50%
• Ostial or proximal left anterior descending artery, dominant left circumflex artery, or dominant right coronary artery stenosis ≥50% and at least one of the following:
• CT-FFR ≤0.80
• At least 2 high-risk plaque characteristics, including:

You may not qualify if:

• 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
• Operator decision to treat a vessel not identified as a target vessel by the CCTA core laboratory analysis
• Pregnancy or breastfeeding
• Patients referred for coronary artery bypass graft surgery after invasive coronary angiography
• Participation in another investigational drug or drug-coated device study
• Inability to provide informed consent

Sponsors & Collaborators

• University of Galway: lead

MeSH Terms

Conditions

Acute Coronary Syndrome; Myocardial Ischemia; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Faisal Sharif, MBBS, PhD, FRCPI, FESC, FACC

  University of Galway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faisal Sharif, MBBS, PhD, FRCPI, FESC, FACC

CONTACT

+353 91524222; faisal.sharif@universityofgalway.ie

Eileen Coen, CNM

CONTACT

+353 86 145 5568; eileen.coen@universityofgalway.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is an open-label trial in which operators performing PCI are aware of treatment allocation after randomization. Participants and treating physicians are not blinded to the assigned intervention. However, assessment of procedural and imaging-related endpoints, including quantitative coronary angiography (QCA), quantitative flow ratio (QFR), angiographic complications, and procedural outcomes, will be performed by a centralized core laboratory blinded to treatment allocation. In the control arm, operators will remain blinded to the advanced CCTA-derived virtual PCI planning throughout the procedure to avoid influencing procedural decision-making.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Faisal Sharif

Model Details: This is a prospective, multicenter, randomized, controlled, open-label, parallel-group trial evaluating the impact of coronary computed tomography angiography (CCTA)-guided procedural planning during percutaneous coronary intervention (PCI). Eligible participants with obstructive coronary artery disease undergoing clinically indicated PCI will be randomized in a 1:1 ratio to either a CCTA-guided PCI strategy or standard angiography-guided PCI. Participants assigned to the intervention arm will undergo PCI using a structured pre-procedural virtual planning workflow derived from centralized CCTA analysis, including lesion characterization, vessel sizing, calcium assessment, and CT-derived functional evaluation. Participants randomized to the control arm will undergo PCI according to standard clinical practice, with operators blinded to the advanced CCTA procedural planning data. A parallel observational registry will also follow deferred target lesions not treated with PCI.

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 18, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): May 20, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 18, 2026

Record last verified: 2026-05