European microCirculatory Resistance and Absolute Flow Team-The Euro-CRAFT Registry Prospective evaluation of the impact of coronary themodilution on clinical outcomes in chronic coronary syndromes

Phase 4

• Conditions: chronic coronary syndromes; disease of the small coronaries; 10011082

• Registration Number: NL-OMON56717
• Lead Sponsor: CoreAalst BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

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.

Exclusion Criteria

. Age <18 years
2. Unable to provide written informed consent (IC)
3. Unstable hemodynamics
4. Ongoing chest pain
5. Previous CABG
6. Moderate to severe valvular heart disease
7. Uncontrolled or recurrent ventricular tachycardia.
8. Active liver disease or hepatic dysfunction, defined as AST or ALT > 3 times
the ULN.
9. Comorbidity with life expectancy <= 2 years.
10. Severe renal dysfunction, defined as an eGFR <30 mL/min/1.73 m2.
11. Subject is currently participating in another investigational drug or
device clinical study.
12. 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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified