Clinical trial NCT03782688: Precise Percutaneous Coronary Intervention Plan (P3) Study
Official title: Prospective Evaluation of a Virtual Non-invasive Percutaneous Intervention Planner in Patients With Coronary Artery Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stable Coronary Artery Disease
Lead sponsor: Onze Lieve Vrouw Hospital
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Stable Coronary Artery Disease with Positive Fractional Flow Reserve and indication for percutaneous myocardial revascularization.

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.

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

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.

Primary outcomes:
measure: Agreement on post-PCI fractional flow reserve between virtual treatment based on FFRct planner and measured invasive post-PCI fractional flow reserve.
timeFrame: The primary endpoint will be assessed immediately after the procedure (PCI).
Secondary outcomes:
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV-Aalst
state: Oost-Vlaanderen
Study officials:
affiliation: OLV-Aalst
name: Bernard De Bruyne, MD, PhD
role: STUDY_CHAIR
References:
citation: Sonck J, Nagumo S, Norgaard BL, Otake H, Ko B, Zhang J, Mizukami T, Maeng M, Andreini D, Takahashi Y, Jensen JM, Ihdayhid A, Heggermont W, Barbato E, Mileva N, Munhoz D, Bartunek J, Updegrove A, Collinsworth A, Penicka M, Van Hoe L, Leipsic J, Koo BK, De Bruyne B, Collet C. Clinical Validation of a Virtual Planner for Coronary Interventions Based on Coronary CT Angiography. JACC Cardiovasc Imaging. 2022 Jul;15(7):1242-1255. doi: 10.1016/j.jcmg.2022.02.003. Epub 2022 Apr 13.