The Euro-CRAFT Registry

NCT ID: NCT05805462

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 671 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-22
• Study Completion Date: 2030-09-22

Brief 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).

Conditions

Coronary Microvascular Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hexacath, France

INDUSTRY

Sponsor Role: collaborator

CoreAalst BV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

OLV Ziekenhuis Aalst

Aalst, , 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

Countries

Belgium; Denmark; Germany; Netherlands; Serbia; Spain; Switzerland; United Kingdom

Other Identifiers

CRI-080

Identifier Type: -

Identifier Source: org_study_id