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Completed

NCT Number: NCT03782688

Precise Percutaneous Coronary Intervention Plan (P3) Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OLV-Aalst

Aalst, Oost-Vlaanderen, 9300, Belgium

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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
  • 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.

Treatment and study plan

FFRCT planner

Diagnostic Test

Non-invasive post-PCI fractional flow reserve prediction

Other names: HeartFlow Planner

Primary outcomes

  1. Agreement on post-PCI fractional flow reserve between virtual treatment based on FFRct planner and measured invasive post-PCI fractional flow reserve.

    Time frame: The primary endpoint will be assessed immediately after the procedure (PCI).

    The agreement will be assessed by Bland Altman method

Sponsors and collaborators

Lead sponsor

Onze Lieve Vrouw Hospital

Other

Registry information

Official study title

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

Acronym: P3

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Dec 20, 2018
Registry last updated
Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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