Revascularization of Calcified Coronary Arteries (PICA)

July 22, 2026 updated by: Ashkan Eftekhari, Aalborg University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ashkan Eftekhari, MD PhD
  • Phone Number: +4597664465
  • Email: asef@rn.dk

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Recruiting
        • Aalborg University Hospital
        • Contact:
          • Julie Juul Siig, MD
          • Phone Number: +45 97 66 00 00
          • Email: j.dyhr@rn.dk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This a prospective clinical cohort study recruiting patients with stable coronary artery disease referred to invasive coronary angiography on clinical indication with angiographic calcium and eligible for PCI.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-PCI FFR
Time Frame: Immediately after the procedure
FFR is measured after PCI is completed.
Immediately after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2030

Study Registration Dates

First Submitted

August 20, 2025

First Submitted That Met QC Criteria

July 22, 2026

First Posted (Actual)

July 23, 2026

Study Record Updates

Last Update Posted (Actual)

July 23, 2026

Last Update Submitted That Met QC Criteria

July 22, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 113255

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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