NL-OMON51757
Recruiting
Phase 4
Pressure Microcatheter vs Pressure Wire for Clinical Decision Making and PCI optimization - INSIGHTFUL-FFR
CoreAalst BV0 sites140 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Stenosis in the coronary arteries and spasm of the heart (angina pectoris)
- Sponsor
- CoreAalst BV
- Enrollment
- 140
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. The subject must be at least 18 years of age and younger than 85 years old.
- •2\. Eligible for elective PCI.
- •3\. Stable angina or ACS (non\-culprit vessels only and outside of primary
- •intervention during acute STEMI)
- •4\. Subject willing to participate and able to understand, read and sign the
- •Informed Consent.
Exclusion Criteria
- •1\. STEMI as clinical presentation.
- •2\. Significant contraindication to adenosine administration (e.g. heart block,
- •severe asthma)
- •3\. Uncontrolled or recurrent ventricular tachycardia.
- •4\. Hemodynamic instability.
- •5\. Severe valvular disease.
- •6\. Severe renal dysfunction, defined as an eGFR \<\=30 mL/min/1\.73 m2\.
- •7\. Comorbidity with life expectancy \<\= 2 years.
- •8\. Inability to take DAPT (both aspirin and a P2Y12 inhibitor) for at least 12
- •months in the patient presenting with an ACS, or at least 6 months in the
Outcomes
Primary Outcomes
Not specified
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