Precise Percutaneous Coronary Intervention Plan (P3) Study

Onze Lieve Vrouw Hospital

Status: Completed

Conditions: Stable Coronary Artery Disease

Treatments: Diagnostic Test: FFRCT planner

Study type: Observational

Funder types: Other

Identifiers

NCT03782688

CVBA-CRI_0001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 127 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

127 participants in 1 patient group

Single-arm cohort

Description:

Patients with significant coronary stenosis by invasive fractional flow reserve (FFR≤0.80)

Treatment:

Diagnostic Test: FFRCT planner