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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Aalborg University Hospital Academic / other |
| Locations | 1 site (Aalborg) |
| Status | Recruiting |
| Started | March 1, 2025 |
| Main results expected | May 1, 2027 |
| Study ends | May 1, 2030 |
| Registry record updated | July 23, 2026 |
| Trial ID | NCT07724184 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
- Study coordinator: Ashkan Eftekhari, MD PhD
- Email: asef@rn.dk
- Phone: +4597664465
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.