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Active, not recruitingNCT05805462Euro-CRAFTUpdated Jan 12, 2026

The Euro-CRAFT Registry

An observational study in Coronary Microvascular Disease, sponsored by CoreAalst BV. Active, not recruiting at 19 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-12.

Sponsored by CoreAalst BV · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
671
Ages
18 Years and older
Sex
All
01

Study 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. 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).

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Conditions studied

  • Coronary Microvascular Disease

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03

In context

Microvascular Angina

123 studies on the registry are indexed under Microvascular Angina; 36 are open to participants now.

This study's planned enrollment of 671 is above the median of 200 across 45 observational studies indexed under Microvascular Angina.

Browse Microvascular Angina studies →

Lead sponsor

CoreAalst BV is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Unable to provide consent
  • Unstable hemodynamics
  • Ongoing chest pain.
  • Previous CABG
  • Moderate to severe valvular heart disease
  • Uncontrolled or recurrent ventricular tachycardia.
  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
671 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 12 months follow-up

Secondary outcomes

  1. 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)

    Time frame: 12 months follow-up

  2. 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).

    Time frame: 12 months follow-up

  3. 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).

    Time frame: 12 months follow-up

  4. 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.

    Time frame: 12 months follow-up

  5. 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.

    Time frame: 12 months follow-up

  6. 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)

    Time frame: 12 months follow-up

07

Study locations

19 sites
  • OLV Ziekenhuis Aalst
    Aalst, 9300, Belgium
  • Righospitalet
    Copenhagen, Denmark
  • University of Mainz
    Mainz, Germany
  • Catharina Hospital
    Eindhoven, Netherlands
  • Radboud Hospital
    Nijmegen, Netherlands
  • Maasstad Ziekenhuis
    Rotterdam, Netherlands
  • University Clinical Center of Serbia, University of Belgrade
    Belgrade, Serbia
  • University Hospital Puerta del Mar
    Cadiz, Spain
  • Clinica La Princesa
    Madrid, Spain
  • San Carlos Hospital
    Madrid, Spain
  • University Hospital Lausanne
    Lausanne, Switzerland
  • Royal United Hospital Bath NHS Foundation Trust
    Bath, United Kingdom
  • Bristol Heart Institute
    Bristol, United Kingdom
  • Basildon Hospital
    Essex, United Kingdom
  • Golden Jubilee National Hospital
    Glasgow, United Kingdom
  • Imperial College
    London, United Kingdom
  • Royal Brompton Hospital
    London, United Kingdom
  • St. Thomas Hospital, King's College
    London, United Kingdom
  • Oxford University Hospitals
    Oxford, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05805462
Lead sponsor
CoreAalst BV
Collaborators
Hexacath, France
Responsible party
Sponsor
First posted
Apr 10, 2023
Start date
Sep 22, 2022
Primary completion
Sep 22, 2026 (estimated)
Completion
Sep 22, 2030 (estimated)
Last update
Jan 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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