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RECRUITING
NCT05437900
PHASE4

INSIGHTFUL-FFR Clinical Trial

Sponsor: CoreAalst BV

View on ClinicalTrials.gov

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

PROCEDURE

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) .

PROCEDURE

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) .

PROCEDURE

Pressure Microcatheter guided strategy - Standard of care

Use of Pressure Microcatheter during PCI. After the PCI, the patient will receive standard of care treatment.

PROCEDURE

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