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Clinical Trials/KCT0008766
KCT0008766
Recruiting
未知

Diagnostic Performance of Angiography-Derived Fractional Flow Reserve XA(FFRXA) Compared to Pressure Wire-Derived Fractional Flow Reserve: A Multicenter, Prospective, Single-blinded Trial

Medipixel0 sites240 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Medipixel
Enrollment
240
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional Study
Sex
All

Investigators

Sponsor
Medipixel

Eligibility Criteria

Inclusion Criteria

  • 1\.Patients with stable and unstable angina pectoris stabilized on medical therapy, or secondary evaluation of stenosis after acute myocardial infarction
  • 2\.Subjects at least 19 years of age
  • 3\.Able to provide written informed consent
  • 4\.Diameter stenosis 30%\-90% by visual estimation
  • 5\.Reference vessel size \= 2\.0 mm in stenosed segment

Exclusion Criteria

  • 1\.Subjects with emergent PCI
  • 2\.Myocardial infarction within 72 hours
  • 3\.Severe asthma or severe chronic obstructive pulmonary disease
  • 4\.Allergy to contrast media or adenosine
  • 5\.Plasma creatinine 2\.0mg/dL or more
  • 6\.Atrial fibrillation
  • 7\.Heart valve replacement
  • 8\.Complex congenital heart disease
  • 9\.Severe heart failure (NYHA \= III), pulmonary edema, cardiogenic shock
  • 10\.Implanted cardiac devices such as pacemakers, implantable cardioverter\-defibrillators, or cardiac resynchronization therapy devices

Outcomes

Primary Outcomes

Not specified

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