Coronary Arterial Disease (CAD)PICANCT07724184
Revascularization of Calcified Coronary Arteries
An observational study of Coronary Arterial Disease (CAD) and Ischemic Heart Disease (IHD), run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Arterial Disease (CAD), Ischemic Heart Disease (IHD), Percutaneous Coronary Intervention (PCI)
- What is being tested?
- Measurement of coronary flow and pressure
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2025to 1 May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age > 18 years
- Moderate (40-90 %) epicardial disease
- Vessel suitable for PCI and intracoronary imaging
- De novo-lesions
Who cannot join
- eGFR < 40ml/min
- ACS < 48 hours
- Patient without ability to provide informed consent
- Patient with left main stenosis
- Indication for coronary artery bypass grafting
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aalborg University Hospital
Aalborg
Julie Juul Siig, MD, +45 97 66 00 00, j.dyhr@rn.dk
About this study
Official title: 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.
- Conditions
- Coronary Arterial Disease (CAD), Ischemic Heart Disease (IHD), Percutaneous Coronary Intervention (PCI)
- Being tested
- Measurement of coronary flow and pressure
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of coronary flow and pressureDiagnostic test
The pressure and flow data will be integrated in a machine learning model
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-PCI FFR
FFR is measured after PCI is completed.
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Mar 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashkan Eftekhari, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724184
- Sponsor's protocol ID
- 113255
- Acronym
- PICA
- Status last verified
- Jul 2026
- First submitted
- 20 Aug 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Coronary Intervention of Calcified Lesions and the Use of Artificial Intelligence to Predict Successful Outcome
- ClinicalTrials.gov ID
- NCT07724184
- Acronym / sponsor ID
- PICA / 113255
- Conditions
- Coronary Arterial Disease (CAD), Ischemic Heart Disease (IHD), Percutaneous Coronary Intervention (PCI)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Age > 18 years
- Moderate (40-90 %) epicardial disease
- Vessel suitable for PCI and intracoronary imaging
- De novo-lesions
Key exclusion criteria (5 listed)
- eGFR < 40ml/min
- ACS < 48 hours
- Patient without ability to provide informed consent
- Patient with left main stenosis
- Indication for coronary artery bypass grafting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of coronary flow and pressureThe pressure and flow data will be integrated in a machine learning model | Diagnostic test | – |
Primary outcome
Post-PCI FFR
Time frame: Immediately after the procedure
FFR is measured after PCI is completed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Arterial Disease (CAD) and Ischemic Heart Disease (IHD), run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashkan Eftekhari, MD PhD (+4597664465, asef@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-PCI FFR (time frame: Immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.