Prospective Evaluation of a Virtual Non-invasive Percutaneous Intervention Planner in Patients With Coronary Artery Disease.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stable Coronary Artery Disease
- Sponsor
- Onze Lieve Vrouw Hospital
- Enrollment
- 127
- Locations
- 1
- Primary Endpoint
- Agreement on post-PCI fractional flow reserve between virtual treatment based on FFRct planner and measured invasive post-PCI fractional flow reserve.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The PRECISE PERCUTANEOUS CORONARY INTERVENTION (PCI) PLAN STUDY is an investigator-initiated, international and multicenter study of patients with an indication for PCI aiming at assessing the agreement and accuracy of the HeartFlow Planner with invasive fractional flow reserve (FFR) as a reference.
Detailed Description
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.
Investigators
Jeroen Sonck
Co-Director Cardiovascular Center OLV-Aalst
Onze Lieve Vrouw Hospital
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
- •Severely calcified lesion/vessel
- •Bifurcation lesions.
- •Ostial lesions.
- •Left main disease.
- •Severe vessel tortuosity.
- •Clinical exclusion criteria
- •Chronic obstructive pulmonary disease
- •Contraindication to adenosine
- •NYHA class III or IV, or last known left ventricular ejection fraction \<30%
Outcomes
Primary Outcomes
Agreement on post-PCI fractional flow reserve between virtual treatment based on FFRct planner and measured invasive post-PCI fractional flow reserve.
Time Frame: The primary endpoint will be assessed immediately after the procedure (PCI).
The agreement will be assessed by Bland Altman method