Coronary Microvascular DiseaseEuro-CRAFTNCT05805462
The Euro-CRAFT Registry
An observational study of Coronary Microvascular Disease, run by CoreAalst BV at 19 sites in 8 countries.
Trial summary
The Euro-CRAFT Registry is a prospective, multicentric, international registry of patients undergoing functional assessment of the coronary microcirculation using the continuous thermodilution technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Microvascular Disease
- How many people
- 671 participants
- Where
- 19 sitesin 8 countries
- Study dates
- 22 Sep 2022to 22 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients in whom physiological assessment of the microcirculatory function including continuous coronary thermodilution has been performed with a Pressure-wire X within the context of routine clinical care.
Who may be able to join
- Age > 18 years.
- Stable patients should have complaints of chest pain suspected of angina pectoris or other symptoms raising the suspicion of IHD and non-obstructive epicardial coronary arteries on invasive coronary angiography (ICA, diameter stenosis of less than 50%) with an FFR >0.80.
- Any other clinical scenario (including in the context of ACS) prompting the physician to assess the function of the coronary microvasculature.
Who cannot join
- Unable to provide consent
- Unstable hemodynamics
- Ongoing chest pain.
- Previous CABG
- Moderate to severe valvular heart disease
- Uncontrolled or recurrent ventricular tachycardia.
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- Active liver disease or hepatic dysfunction, defined as AST or ALT > 3 times the ULN.
- Comorbidity with life expectancy <= 2 years.
- Severe renal dysfunction, defined as an eGFR <30 mL/min/1.73 m2.
- Subject is currently participating in another investigational drug or device clinical study.
- Presence of other anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
Trial locations and contacts
19 sites in 8 countries.
19 sites in 8 countries
United Kingdom8 sites
Royal United Hospital Bath NHS Foundation Trust
Bath
Bristol Heart Institute
Bristol
Basildon Hospital
Essex
Golden Jubilee National Hospital
Glasgow
Imperial College
London
Royal Brompton Hospital
London
St. Thomas Hospital, King's College
London
Oxford University Hospitals
Oxford
Netherlands3 sites
Catharina Hospital
Eindhoven
Radboud Hospital
Nijmegen
Maasstad Ziekenhuis
Rotterdam
Spain3 sites
University Hospital Puerta del Mar
Cadiz
Clinica La Princesa
Madrid
San Carlos Hospital
Madrid
Serbia1 site
University Clinical Center of Serbia, University of Belgrade
Belgrade
About this study
Official title: European microCirculatory Resistance and Absolute Flow Team: The Euro-CRAFT Registry
The Euro-CRAFT Registry is a prospective, multicentric, international registry of patients undergoing functional assessment of the coronary microcirculation using the continuous thermodilution technique. Angina and quality of life questionnaires (Seattle Angina Questionnaire 19 - SAQ19, ORBITA app) will be obtained at baseline, at 6 months, and 1-year follow-up. Clinical follow-up will be performed at 1 year (optionally until 5 years).
- Conditions
- Coronary Microvascular Disease
- Medical subject headings
- Microvascular Angina
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of MACCE between patients with and without CMD based on MRR at 1-year follow-up.
Rate of Major Adverse Cardiac and Cerebrovascular Events at one year (MACCE defined as cardiovascular death, angina and heart failure related hospitalisations and stroke) between patients with and without Coronary Microvascular Disease (CMD) defined according to thermodilution derived metrics (Microvascular Resistance Reserve, MRR).
Measured: 12 months follow-up
Secondary outcomes (6)
Relationship between MACCE's and each thermodilution- derived metrics of microvascular function
Relationship between Major Adverse Cardiac and Cerebrovascular Events (MACCE defined as cardiovascular death, angina and heart failure related hospitalisations and stroke) and each thermodilution-derived metrics of microvascular function (i.e. absolute hyperemic flow, absolute hyperemic resistance, Index of Microvascular Resistance, and Coronary Flow Reserve)
Measured: 12 months follow-up
Relationship between the presence and severity of angina, assessed by SAQ- 19, and each individual thermodilution-derived metrics of microvascular function
Relationship between the presence and severity of angina, assessed by Seattle Angina Questionnaire 19, and each individual thermodilution-derived metrics of microvascular function (i.e., absolute hyperemic flow, absolute hyperemic resistance,Index of Microvascular Resistance and Coronary Flow Reserve).
Measured: 12 months follow-up
Relationship between the presence and severity of angina, assessed by the ORIBTA Euro-CRAFT app, and each individual thermodilution-derived metrics of microvascular function
Relationship between the presence and severity of angina, assessed by the ORBITA Euro-CRAFT app, and each individual thermodilution-derived metrics of microvascular function (i.e., absolute hyperemic flow, absolute hyperemic resistance, Index of Microvascular Resistance and Coronary Flow Reserve).
Measured: 12 months follow-up
Safety of continuous and bolus thermodilution measurements, as assessed by adverse event registration.
Safety of continuous and bolus thermodilution measurements, as assessed by adverse event registration.
Measured: 12 months follow-up
To determine cut-off values of thermodilution-derived indices
To determine cut-off values of thermodilution-derived indices (i.e. absolute hyperemic flow, absolute hyperemic resistance, Index of Microvascular Resistance and Coronary Flow Reserve to assess the presence of Coronary Microvascular Disease.
Measured: 12 months follow-up
To assess the prevalence of Coronary Microvascular Disease based on Microvascular Resistance Reserve in patients with angina and non-obstructive coronary artery disease (NOCAD)
To assess the prevalence of CMD based onMicrovascular Resistance Reserve (MRR) in patients with angina and non-obstructive coronary artery disease (NOCAD)
Measured: 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start22 Sep 2022
- Primary completion22 Sep 2026 (estimated)
- Study completion22 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Microvascular 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
- 671 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CoreAalst BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hexacath, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805462
- Sponsor's protocol ID
- CRI-080
- Acronym
- Euro-CRAFT
- Status last verified
- Jan 2026
- First submitted
- 2 Mar 2023
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European microCirculatory Resistance and Absolute Flow Team: The Euro-CRAFT Registry
- ClinicalTrials.gov ID
- NCT05805462
- Acronym / sponsor ID
- Euro-CRAFT / CRI-080
- Conditions
- Coronary Microvascular Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 671 participants (estimated)
- Lead sponsor
- CoreAalst BVIndustry (pharma, biotech, devices)
- Collaborators
- Hexacath, France
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 22 Sep 2026 (estimated)
- Study completion
- 22 Sep 2030 (estimated)
- First posted
- 10 Apr 2023 (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 Euro-CRAFT Registry is a prospective, multicentric, international registry of patients undergoing functional assessment of the coronary microcirculation using the continuous thermodilution technique. Angina and quality of life questionnaires (Seattle Angina Questionnaire 19 - SAQ19, ORBITA app) will be obtained at baseline, at 6 months, and 1-year follow-up. Clinical follow-up will be performed at 1 year (optionally until 5 years).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients in whom physiological assessment of the microcirculatory function including continuous coronary thermodilution has been performed with a Pressure-wire X within the context of routine clinical care.
Key inclusion criteria (3 listed)
- Age > 18 years.
- Stable patients should have complaints of chest pain suspected of angina pectoris or other symptoms raising the suspicion of IHD and non-obstructive epicardial coronary arteries on invasive coronary angiography (ICA, diameter stenosis of less than 50%) with an FFR >0.80.
- Any other clinical scenario (including in the context of ACS) prompting the physician to assess the function of the coronary microvasculature.
Key exclusion criteria (11 listed)
- Unable to provide consent
- Unstable hemodynamics
- Ongoing chest pain.
- Previous CABG
- Moderate to severe valvular heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The rate of MACCE between patients with and without CMD based on MRR at 1-year follow-up.
Time frame: 12 months follow-up
Rate of Major Adverse Cardiac and Cerebrovascular Events at one year (MACCE defined as cardiovascular death, angina and heart failure related hospitalisations and stroke) between patients with and without Coronary Microvascular Disease (CMD) defined according to thermodilution derived metrics (Microvascular Resistance Reserve, MRR).
6 secondary outcomes
Relationship between MACCE's and each thermodilution- derived metrics of microvascular function
Time frame: 12 months follow-up
Relationship between the presence and severity of angina, assessed by SAQ- 19, and each individual thermodilution-derived metrics of microvascular function
Time frame: 12 months follow-up
Relationship between the presence and severity of angina, assessed by the ORIBTA Euro-CRAFT app, and each individual thermodilution-derived metrics of microvascular function
Time frame: 12 months follow-up
Safety of continuous and bolus thermodilution measurements, as assessed by adverse event registration.
Time frame: 12 months follow-up
To determine cut-off values of thermodilution-derived indices
Time frame: 12 months follow-up
To assess the prevalence of Coronary Microvascular Disease based on Microvascular Resistance Reserve in patients with angina and non-obstructive coronary artery disease (NOCAD)
Time frame: 12 months follow-up
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 12 Jan 2026.
- Individual participant dataSharing planned: No
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Microvascular Angina
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Microvascular Disease, run by CoreAalst BV at 19 sites in 8 countries.
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 3 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United Kingdom, Netherlands, Spain, Belgium, Denmark and 3 more countries. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of MACCE between patients with and without CMD based on MRR at 1-year follow-up. (time frame: 12 months follow-up). 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 12 Jan 2026.