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Clinical Trials/NL-OMON45522
NL-OMON45522
Completed
Not Applicable

Physiologic Assessment of Coronary Stenosis Following PCI - DEFINE PCI

Philips Volcano0 sites40 target enrollmentTBD
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Conditionsblockage in heart arterycoronary stenosis10011082

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
blockage in heart artery
Sponsor
Philips Volcano
Enrollment
40
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

Sponsor
Philips Volcano

Eligibility Criteria

Inclusion Criteria

  • •1\.Subject must be \> 18 years old
  • •2\.Subjects presenting with stable angina, silent ischemia or non\-ST\-elevation ACS (unstable angina or biomarker positive)
  • •3\.Single vessel CAD with at least 2 separate lesions (\*10 mm apart) of \*40% stenosis or a single long lesion of \*20mm OR multi\-vessel CAD, defined as at least 2 vessels with \*40% stenosis
  • •4\.Pre\-PCI iFR performed in all vessels intended for PCI
  • •5\.Pre\-PCI iFR of \<0\.90 of at least 1 stenosis
  • •6\.Subjects are able and willing to comply with scheduled visits and tests and to provide informed consent.

Exclusion Criteria

  • •1\.Pregnant or planning to become pregnant for the duration of the study
  • •2\.Acute STEMI within the past 7 days
  • •3\.Cardiogenic shock (sustained (\>10 min) systolic blood pressure \< 90 mmHg in absence of inotropic support or the presence of an intra\-aortic balloon pump).
  • •4\.Ionotropic or temporary pacing requirement
  • •5\.Sustained ventricular arrhythmias
  • •6\.Prior CABG
  • •7\.Known ejection fraction \*30%
  • •8\.Chronic Total Occlusion (CTO)
  • •9\.Known severe mitral or aortic stenosis.
  • •10\.Any known medical comorbidity resulting in life expectancy \< 12 months.

Outcomes

Primary Outcomes

Not specified

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