Brief Summary

Recently, a new device for measuring physiological lesion severity, the pressure microcatheter, was introduced. The pressure microcatheter provides similar information to the conventional measurement technique but differs as it is easily advanced on a customary coronary wire and simplifies pullback maneuvers. The pressure microcatheter has been shown to provide comparable FFR results to pressure wires.

Insightful-FFR is an investigator-driven, multicenter, randomized, open-label and prospective trial of patients with stable coronary artery disease or stabilised non-ST elevation acute coronary syndrome (ACS) with epicardial stenosis considered for PCI aiming at comparing clinical outcomes between pressure microcatheter and pressure wire-guided strategies. The study hypothesis states that the use of a Pressure Microcatheter for clinical decision making would be non-inferior to pressure wire-based strategy

After determining the presence of a coronary artery disease/ stabilized acute coronary syndrome, patients will be randomized to use a pressure microcatheter (investigational device) or a pressure wire (comparator) to guide and optimize percutaneous coronary intervention (PCI). Patients will be followed up in hospital at 12 months and yearly until five years.

Conditions

• Coronary Artery Disease
• Acute Coronary Syndrome

Intervention / Treatment

• Procedure: Pressure Microcatheter guided strategy - PIOS MC
• Procedure: Pressure Wire guided strategy - PIOS - PW
• Procedure: Pressure Microcatheter guided strategy - Standard of care
• Procedure: Pressure Wire guided strategy - Standard of care

Primary Outcome Measures

• Compare the rate of MACE between pressure microcatheter and pressure wire strategies. (12 Months follow-up)
  Compare the rate of major adverse cardiovascular events (MACE) defined as the combined rate of all cause death, myocardial infarction (MI), and unplanned revascularization between pressure microcatheter and pressure wire strategies at 12-months follow-up.

Countries

Belgium, China, France, Germany, Italy, Netherlands, Poland, Spain

Locations and Investigators

• OLV Aalst, Aalst, Belgium (Recruiting)
  • Hilde Delacroix
  • Carlos Collet, MD, PhD (Principal Investigator)
  • Bernard De Bruyne, MD, PhD (Principal Investigator)
• Universitair ziekenhuis Brussel, Brussels, Belgium (Recruiting)
  • Marnix von Kemp, Md
  • Marnix von Kemp, MD (Principal Investigator)
• ZOL, Genk, Belgium (Recruiting)
  • Daan Cottens, MD
  • Daan Cottens, MD (Principal Investigator)
• Zhongshan Hospital of Fudan University, Shanghai, China (Active not recruiting)
• QILU Hospital of Shandong University, Shandong, China (Active not recruiting)
• West China Hospital of Sichuan University, Sichuan, China (Active not recruiting)
• CHU Lille, Lille, France (Recruiting)
  • Eric Van Belle, MD
  • Eric Van Belle, MD (Principal Investigator)
• Claude Bernard University, Lyon, France (Active not recruiting)
• ICPS, Paris, France (Recruiting)
  • Nicolas Amabile, MD
  • Nicolas Amabile, MD (Principal Investigator)
• Herzzentrum Dresden, Dresden, Germany (Recruiting)
  • Felix Woitek, MD
  • Felix Woitek (Principal Investigator)
• Klinikum Fürth, Fürth, Germany (Recruiting)
  • Stylianos Pyxaras, MD,PhD
  • Stylianos Pyxaras, MD, PhD (Principal Investigator)
• Klinikum Herford, Herford, Germany (Recruiting)
  • Dominik Gorski, MD
  • Dominik Gorski, MD (Principal Investigator)
• Catholic Medical Center Koblenz-Montabaur, Koblenz, Germany (Active not recruiting)
• Herzzentrum Lahr, Lahr, Germany (Recruiting)
  • Kambis Mashayekhi, MD, PhD
  • Kambis Mashayekhi, MD, PhD (Principal Investigator)
• Universitätsklinik, Mainz, Germany (Recruiting)
  • Tommaso Gori, MD, PhD
  • Tommaso Gori, MD, PhD (Principal Investigator)
• Nuovo Arcispedale S.Anna Di Ferrara, Ferrara, Italy (Recruiting)
  • Gianluca Campo, MD
  • Gianluca Campo, MD (Principal Investigator)
• Ospedale Civile Sant'Andrea, La Spezia, Italy (Recruiting)
  • Marco Arena, MD
  • Marco Arena (Principal Investigator)
• Ospedale Santa Maria Goretti, Latina, Italy (Recruiting)
  • Iginio Colaiori, MD
  • Iginio Colaiori, MD (Principal Investigator)
• Azienda Ospedaliera Universitaria Federico II, Naples, Italy (Recruiting)
  • Giovanni Esposito, MD
  • Giovanni Esposito, MD (Principal Investigator)
• Azienda Ospedaliera Universitaria Sant'Andrea, Rome, Italy (Recruiting)
  • Emanuele Barbato, MD
  • Emanuele Barbato, MD (Principal Investigator)
• Amsterdam UMC, Amsterdam, Netherlands (Recruiting)
  • Marcel Beijk, MD
  • Marcel Beijk, MD (Principal Investigator)
• Catharina Ziekenhuis, Eindhoven, Netherlands (Recruiting)
  • Pim Tonino, MD
  • Pim Tonino, MD (Principal Investigator)
• UMCN Radboud, Nijmegen, Netherlands (Recruiting)
  • Lokien Van Nunen, MD
  • Lokien Van Nunen, MD (Principal Investigator)
• Dr. Jurasz University Hospital No. 1, Bydgoszcz, Poland (Recruiting)
  • Adam Sukiennik, MD
  • Adam Sukiennik (Principal Investigator)
• John Paul II Specialistic Hospital, Krakow, Poland (Recruiting)
  • Jacek Legutko, MD
  • Jacek Legutko, MD (Principal Investigator)
• National Cardiac Institute, Warsaw, Poland (Recruiting)
  • Adam Witkowski, MD, PhD
  • Adam Witkowski, MD, PhD (Principal Investigator)
• Hospital Clínic Barcelona, Barcelona, Spain (Recruiting)
  • Salvatore Brugaletta, MD, PhD
  • Salvatore Brugaletta, MD, PhD (Principal Investigator)
• Germans Trias i Pujol Hopital, Barcelona, Spain (Recruiting)
  • Oriol Rodriguez, MD
  • Oriol Rodriguez, MD (Principal Investigator)
• Hospital de Belvitge, Barcelona, Spain (Recruiting)
  • Josep Gomez Lara, MD
  • Josep Gomez Lara (Principal Investigator)

Study Officials

• Emanuele Barbato, MD, PhD (Principal Investigator) — Azienda Ospedaliera Universitaria Sant'Andrea, Roma
• Carlos Collet, MD, PhD (Principal Investigator) — CoreAalst BV
• Junbo Ge, MD (Principal Investigator) — Zhongshan Hospital, Fudan University, Shanghai
• Salvatore Brugaletta, MD, PhD (Principal Investigator) — Hospital Clinic of Barcelona