Precise Percutaneous Coronary Intervention Plan (P3) Study

Launched by ONZE LIEVE VROUW HOSPITAL · Dec 19, 2018

Keywords

ClinConnect Summary

Multicenter study, including 120 patients at 5 centers in Europe and Asia. After identifying the presence of significant coronary stenosis by means of coronary angiography and invasive fractional flow reserve (FFR≤0.80) the patients will undergo the following procedures: Invasive FFR with intravenous adenosine (i.e. pre- and post-PCI). Optical coherence tomography-guided PCI (i.e. pre- and post-procedural imaging). PCI with newer generation drug-eluting stent.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Coronary artery disease in a major epicardial vessel with an invasive fractional flow reserve (FFR) ≤0.80
• • An indication to Percutaneous coronary intervention
• Exclusion Criteria:
• • - Angiographic exclusion criteria
• • 1. Severely calcified lesion/vessel
• • 2. Bifurcation lesions.
• • 3. Ostial lesions.
• • 4. Left main disease.
• • 5. Severe vessel tortuosity.
• • Clinical exclusion criteria
• • 1. Chronic obstructive pulmonary disease
• • 2. Contraindication to adenosine
• • 3. NYHA class III or IV, or last known left ventricular ejection fraction \<30%
• • 4. Uncontrolled or recurrent ventricular tachycardia
• • 5. Atrial fibrillation, flutter or arrhythmia
• • 6. History of recent stroke (≤90 days)
• • 7. History of acute coronary syndrome (≤90 days)
• • 8. Prior myocardial infarction
• • 9. History of ischemic stroke (\>90 days) with modified RANKIN score ≥ 2
• • 10. History of any hemorrhagic stroke
• • 11. Previous revascularization (PCI or Coronary artery bypass grafting)
• • 12. Active liver disease or hepatic dysfunction, defined as AST or ALT \> 3 times the ULN
• • 13. Severe renal dysfunction, defined as an eGFR \<30 mL/min/1.73 m2
• • 14. Body mass index\>35 kg/m2
• • 15. Nitrate intolerance
• • 16. Contra-indication to heart rate lowering drugs
• • Imaging-related
• • 17. Insufficient coronary CT Angiography image quality.