Pressure Microcatheter vs Pressure Wire for Clinical Decision Making and PCI optimizatio
- Conditions
- Stenosis in the coronary arteries and spasm of the heart (angina pectoris)100110821000759310003216
- Registration Number
- NL-OMON51757
- Lead Sponsor
- CoreAalst BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 140
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.
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
patient presenting with stable CAD, unless the patient is also taking chronic
oral anticoagulation in which case a shorter duration of DAPT may be prescribed
per local standard of care.
9. Planned major cardiac or non-cardiac surgery within 24 months after the
index procedure.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Rate of major adverse cardiovascular events (MACE) defined as the combined rate<br /><br>of all-cause death, myocardial infarction (MI), and unplanned revascularization<br /><br>between pressure microcatheter and pressure wire strategies at 12-month<br /><br>follow-up.</p><br>
- Secondary Outcome Measures
Name Time Method