Precise Percutaneous Coronary Intervention Plan (P3) Study

Completed

• Conditions: Stable Coronary Artery Disease
• Interventions: Diagnostic Test: FFRCT planner

• Registration Number: NCT03782688
• Lead Sponsor: Onze Lieve Vrouw Hospital

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.

Study Timeline

• Study First Submitted: 2018-12-12
• Study First Submitted QC: 2018-12-19
• Study First Posted: 2018-12-20
• Study Start: 2019-02-01
• Primary Completion: 2020-12-18
• Study Completion: 2021-12-18
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single-arm cohort	FFRCT planner	Patients with significant coronary stenosis by invasive fractional flow reserve (FFR≤0.80)

Primary Outcome Measures

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

Trial Locations

Locations (1)

OLV-Aalst; 🇧🇪 Aalst, Oost-Vlaanderen, Belgium