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INSIGHTFUL-FFR Clinical Trial
Sponsor: CoreAalst BV
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.
Official title: Pressure Microcatheter vs Pressure Wire for Clinical Decision Making and PCI Optimization
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
2500
Start Date
2022-09-22
Completion Date
2030-06-30
Last Updated
2026-01-12
Healthy Volunteers
No
Interventions
Pressure Microcatheter guided strategy - PIOS MC
Use of Pressure Microcatheter during PCI. After the PCI, the patient will receive treatment according to the incremental optimization strategy (PIOS) .
Pressure Wire guided strategy - PIOS - PW
Use of Pressure Wire during PCI. After the PCI, the patient will receive treatment according to the incremental optimization strategy (PIOS) .
Pressure Microcatheter guided strategy - Standard of care
Use of Pressure Microcatheter during PCI. After the PCI, the patient will receive standard of care treatment.
Pressure Wire guided strategy - Standard of care
Use of Pressure Wire during PCI. After the PCI, the patient will receive standard of care treatment.
Locations (29)
OLV Aalst
Aalst, Oost-Vlaanderen, Belgium
Universitair ziekenhuis Brussel
Brussels, Belgium
ZOL
Genk, Belgium
Zhongshan Hospital of Fudan University
Shanghai, Xuhui District, China
QILU Hospital of Shandong University
Shandong, China
West China Hospital of Sichuan University
Sichuan, China
CHU Lille
Lille, France
Claude Bernard University
Lyon, France
ICPS
Paris, France
Herzzentrum Dresden
Dresden, Germany
Klinikum Fürth
Fürth, Germany
Klinikum Herford
Herford, Germany
Catholic Medical Center Koblenz-Montabaur
Koblenz, Germany
Herzzentrum Lahr
Lahr, Germany
Universitätsklinik
Mainz, Germany
Nuovo Arcispedale S.Anna Di Ferrara
Ferrara, Italy
Ospedale Civile Sant'Andrea
La Spezia, Italy
Ospedale Santa Maria Goretti
Latina, Italy
Azienda Ospedaliera Universitaria Federico II
Naples, Italy
Azienda Ospedaliera Universitaria Sant'Andrea
Rome, Italy
Amsterdam UMC
Amsterdam, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
UMCN Radboud
Nijmegen, Netherlands
Dr. Jurasz University Hospital No. 1
Bydgoszcz, Poland
John Paul II Specialistic Hospital
Krakow, Poland
National Cardiac Institute
Warsaw, Poland
Hospital Clínic Barcelona
Barcelona, Spain
Germans Trias i Pujol Hopital
Barcelona, Spain
Hospital de Belvitge
Barcelona, Spain