Clinical trial Recruiting at 1 site Observational Ages 18 to 90

Revascularization of Calcified Coronary Arteries

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

Run by Aalborg University Hospital · NCT07724184 · Data updated 2026-11-12

This study tests whether measuring blood flow and pressure before and after ballooning or stenting of calcified coronary arteries can help predict how well the procedure will work for adults with heart disease.

More Coronary Arterial Disease (CAD) trials

Quick facts

Study typeObservational
Ages18 Years to 90 Years
SexAll
Enrollment100 (estimated)
SponsorAalborg University Hospital
Academic / other
Locations1 site (Aalborg)
StatusRecruiting
StartedMarch 1, 2025
Main results expectedMay 1, 2027
Study endsMay 1, 2030
Registry record updatedJuly 23, 2026
Trial IDNCT07724184 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults over 18 with moderate (40-90%) epicardial disease suitable for PCI and intracoronary imaging, with de novo lesions.

Probably not a fit

Patients with left main stenosis, recent ACS (<48 hours), significant kidney impairment (eGFR <40 mL/min), or those unable to provide informed consent may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will measure absolute coronary flow and pressure before and after percutaneous coronary intervention in calcified lesions to understand physiological changes. In addition, a machine learning model will be developed to predict the outcome of the intervention. Eligible participants are adults with moderate epicardial coronary disease who are candidates for PCI and intracoronary imaging, with de novo lesions. Exclusions include severely reduced kidney function, recent acute coronary syndrome, inability to consent, left main disease, or a plan for bypass surgery. The study is led by Aalborg University Hospital with no additional collaborators and is conducted at Aalborg University Hospital in Aalborg, Denmark.

Why it matters

Potential benefit: If successful, the approach could improve understanding of how calcified arteries respond to PCI and help predict procedure outcomes for individual patients.

How similar studies have gone: Previous research in this area has explored physiological measurements during PCI, with varying success in predicting outcomes; this study adds a machine learning prediction component.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Aalborg University Hospital
    Aalborg, Denmark
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.