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Recruiting NCT07724184

Revascularization of Calcified Coronary Arteries

— Observational Coronary Arterial Disease (CAD) Ischemic Heart Disease (IHD) Percutaneous Coronary Intervention (PCI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Measurement of coronary flow and pressure.
Who it may be relevant to
Registry conditions: Coronary Arterial Disease (CAD), Ischemic Heart Disease (IHD), Percutaneous Coronary Intervention (PCI). Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Percutaneous Coronary Intervention of Calcified Lesions and the Use of Artificial Intelligence to Predict Successful Outcome

Overview

The primary aim of this study is to evaluate changes in absolute coronary flow and pressure before and after percutaneous coronary intervention in calcified lesions. The secondary aim is to use a machine learning model to predict the outcome of the intervention.

Interventions

  • Diagnostic test Measurement of coronary flow and pressure
    The pressure and flow data will be integrated in a machine learning model

Primary outcome measures

  • Post-PCI FFR [Time frame: Immediately after the procedure]

Eligibility criteria

Inclusion criteria

  • Age > 18 years
  • Moderate (40-90 %) epicardial disease
  • Vessel suitable for PCI and intracoronary imaging
  • De novo-lesions

Exclusion criteria

  • eGFR < 40ml/min
  • ACS < 48 hours
  • Patient without ability to provide informed consent
  • Patient with left main stenosis
  • Indication for coronary artery bypass grafting

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • Aalborg University Hospital — Aalborg

Identifiers

NCT: NCT07724184 · 113255

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗