Coronary Artery DiseaseCardio-FRNCT04185285
Percutaneous Coronary Intervention Registry FRIBOURG
An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention, run by University of Freiburg at 1 site in Switzerland.
Trial summary
The registry aims to follow clinically all consecutive patients treated by percutaneous coronary interventions at hospital \& university Fribourg. Read more about this study
- Who is it for?
- Ages 17 to 120 years
- Conditions the study is for
- Coronary Artery Disease, Percutaneous Coronary Intervention
- What is being tested?
- Percutaneous coronary intervention, stents
- Type of treatment
- Medical device
- How many people
- 3,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2015to 1 Sep 2027
- How long will I take part?
- 10 Years
- 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 17 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All comers
Who may be able to join
- All consecutive patients treated by percutaneous coronary intervention at our institution
- Able to give informed consent and willing to participate
Who cannot join
- Unwillingness to participate
- Enable to provide inform consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Cardiology, university Fribourg Medical Center
Fribourg, 1708
Cook Y. Stephane, MD, +41263063800, stephane.cook@unifr.ch
Masset Lea, BSc, +41263063800, lea.masset@h-fr.ch
About this study
The registry aims to follow clinically all consecutive patients treated by percutaneous coronary interventions at hospital \& university Fribourg.
- Being tested
- Percutaneous coronary intervention, stents
- Keywords
- PCI
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary intervention, stentsDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-oriented composite endpoints (POCE)
Academic Research Consortium definition
Measured: 2 years
Major Bleeding
Bleeding Academic Research Consortium definition
Measured: 2 years
Patient-oriented composite endpoints (POCE)
Academic Research Consortium definition
Measured: 5 years
Major Bleeding
Bleeding Academic Research Consortium definition
Measured: 5 years
Patient-oriented composite endpoints (POCE)
Academic Research Consortium definition
Measured: 10 years
Major Bleeding
Bleeding Academic Research Consortium definition
Measured: 10 years
Secondary outcomes (3)
all-cause death
Academic Research Consortium definition
Measured: 2 years
any revascularization
Academic Research Consortium definition
Measured: 2 years
any myocardial infarction
Academic Research Consortium definition
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start1 May 2015
- Primary completion1 Sep 2017
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- 3,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Freiburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stéphane Cook, Prof, University of Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185285
- Sponsor's protocol ID
- 003-REP-CER-FR-2
- Acronym
- Cardio-FR
- Status last verified
- Oct 2021
- First submitted
- 14 Nov 2019
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aellen G, Garin D, Faucherre Y, Puricel S, Togni M, Cook S. Incidence of Periprocedural Myocardial Injury and Infarction After Intravascular Lithotripsy for Calcified Coronary Artery Stenosis. Catheter Cardiovasc Interv. 2026 Sep 8. doi: 10.1002/ccd.70868. Online ahead of print.
PubMed 42711914Cook ST, Allemann L, Cook M, Arroyo DA, Pittet T, Meier P, Togni M, Brahim-Mathiron A, Puricel S, Cook S. Sex differences in ST-segment elevation myocardial infarction patients treated by primary percutaneous intervention. Open Heart. 2025 Jan 4;12(1):e002831. doi: 10.1136/openhrt-2024-002831.
PubMed 39756819
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Coronary Intervention Registry FRIBOURG
- ClinicalTrials.gov ID
- NCT04185285
- Acronym / sponsor ID
- Cardio-FR / 003-REP-CER-FR-2
- Keywords
- PCI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of FreiburgUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 4 Dec 2019 (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 registry aims to follow clinically all consecutive patients treated by percutaneous coronary interventions at hospital \& university Fribourg.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 17 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All comers
Key inclusion criteria (2 listed)
- All consecutive patients treated by percutaneous coronary intervention at our institution
- Able to give informed consent and willing to participate
Key exclusion criteria (2 listed)
- Unwillingness to participate
- Enable to provide inform consent
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 |
|---|---|---|
| Percutaneous coronary intervention, stents | Device | – |
Primary outcome
Patient-oriented composite endpoints (POCE)
Time frame: 2 years
Academic Research Consortium definition
Major Bleeding
Time frame: 2 years
Bleeding Academic Research Consortium definition
Patient-oriented composite endpoints (POCE)
Time frame: 5 years
Academic Research Consortium definition
Major Bleeding
Time frame: 5 years
Bleeding Academic Research Consortium definition
Patient-oriented composite endpoints (POCE)
Time frame: 10 years
Academic Research Consortium definition
Major Bleeding
Time frame: 10 years
Bleeding Academic Research Consortium definition
3 secondary outcomes
all-cause death
Time frame: 2 years
any revascularization
Time frame: 2 years
any myocardial infarction
Time frame: 2 years
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 22 Oct 2021.
- Derived from this study: PubMed 42711914Aellen G, Garin D, Faucherre Y, Puricel S, Togni M, Cook S. Incidence of Periprocedural Myocardial Injury and Infarction After Intravascular Lithotripsy for Calcified Coronary Artery Stenosis. Catheter Cardiovasc Interv. 2026 Sep 8. doi: 10.1002/ccd.70868. Online ahead of print.
- Derived from this study: PubMed 39756819Cook ST, Allemann L, Cook M, Arroyo DA, Pittet T, Meier P, Togni M, Brahim-Mathiron A, Puricel S, Cook S. Sex differences in ST-segment elevation myocardial infarction patients treated by primary percutaneous intervention. Open Heart. 2025 Jan 4;12(1):e002831. doi: 10.1136/openhrt-2024-002831.
- Individual participant dataSharing planned: No
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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.
Cardiology, university Fribourg Medical Center
Fribourg, Switzerland
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 Artery Disease and Percutaneous Coronary Intervention, run by University of Freiburg at 1 site in Switzerland.
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 2 inclusion and 2 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 22 Oct 2021. 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 Switzerland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-oriented composite endpoints (POCE) (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04185285, which also lists 2 linked publications.
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 22 Oct 2021.