Status:
COMPLETED
Precise Percutaneous Coronary Intervention Plan (P3) Study
Lead Sponsor:
Onze Lieve Vrouw Hospital
Conditions:
Stable Coronary Artery Disease
Eligibility:
All Genders
18+ years
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 agreeme...
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...
Eligibility Criteria
Inclusion
- Coronary artery disease in a major epicardial vessel with an invasive fractional flow reserve (FFR) ≤0.80
- An indication to Percutaneous coronary intervention
Exclusion
- \- 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%
- Uncontrolled or recurrent ventricular tachycardia
- Atrial fibrillation, flutter or arrhythmia
- History of recent stroke (≤90 days)
- History of acute coronary syndrome (≤90 days)
- Prior myocardial infarction
- History of ischemic stroke (\>90 days) with modified RANKIN score ≥ 2
- History of any hemorrhagic stroke
- Previous revascularization (PCI or Coronary artery bypass grafting)
- Active liver disease or hepatic dysfunction, defined as AST or ALT \> 3 times the ULN
- Severe renal dysfunction, defined as an eGFR \<30 mL/min/1.73 m2
- Body mass index\>35 kg/m2
- Nitrate intolerance
- Contra-indication to heart rate lowering drugs
- Imaging-related
- Insufficient coronary CT Angiography image quality.
Key Trial Info
Start Date :
February 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 18 2021
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT03782688
Start Date
February 1 2019
End Date
December 18 2021
Last Update
March 23 2023
Active Locations (1)
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1
OLV-Aalst
Aalst, Oost-Vlaanderen, Belgium, 9300