Precise Percutaneous Coronary Intervention Plan (P3) Study

Stable Coronary Artery Disease Clinical Trial

— P3  

Official title:

Prospective Evaluation of a Virtual Non-invasive Percutaneous Intervention Planner in Patients With Coronary Artery Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03782688
• Other study ID #: CVBA-CRI_0001
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: December 18, 2021

Study information

• Verified date: March 2023
• Source: Onze Lieve Vrouw Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: December 18, 2021
• Est. primary completion date: December 18, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Stable Coronary Artery Disease

Intervention

Diagnostic Test:
• FFRCT planner
Non-invasive post-PCI fractional flow reserve prediction

Locations

Country	Name	City	State
Belgium	OLV-Aalst	Aalst	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
Onze Lieve Vrouw Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement on post-PCI fractional flow reserve between virtual treatment based on FFRct planner and measured invasive post-PCI fractional flow reserve.	The agreement will be assessed by Bland Altman method	The primary endpoint will be assessed immediately after the procedure (PCI).