INSIGHTFUL-FFR Clinical Trial
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- 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.
Trial sites (29)
| Facility | City | Region | Status |
|---|---|---|---|
| OLV Aalst | Aalst | Oost-Vlaanderen | Recruiting |
| Universitair ziekenhuis Brussel | Brussels | Belgium | Recruiting |
| ZOL | Genk | Belgium | Recruiting |
| Zhongshan Hospital of Fudan University | Shanghai | Xuhui District | 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 |
| Claude Bernard University | Lyon | France | Active Not Recruiting |
| ICPS | Paris | France | Recruiting |
| Herzzentrum Dresden | Dresden | Germany | Recruiting |
| Klinikum Fürth | Fürth | Germany | Recruiting |
| Klinikum Herford | Herford | Germany | Recruiting |
| Catholic Medical Center Koblenz-Montabaur | Koblenz | Germany | Active Not Recruiting |
| Herzzentrum Lahr | Lahr | Germany | Recruiting |
| Universitätsklinik | Mainz | Germany | Recruiting |
| Nuovo Arcispedale S.Anna Di Ferrara | Ferrara | Italy | Recruiting |
| Ospedale Civile Sant'Andrea | La Spezia | Italy | Recruiting |
| Ospedale Santa Maria Goretti | Latina | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Federico II | Naples | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Sant'Andrea | Rome | Italy | Recruiting |
| Amsterdam UMC | Amsterdam | Netherlands | Recruiting |
| Catharina Ziekenhuis | Eindhoven | Netherlands | Recruiting |
| UMCN Radboud | Nijmegen | Netherlands | Recruiting |
| Dr. Jurasz University Hospital No. 1 | Bydgoszcz | Poland | Recruiting |
| John Paul II Specialistic Hospital | Krakow | Poland | Recruiting |
| National Cardiac Institute | Warsaw | Poland | Recruiting |
| Hospital Clínic Barcelona | Barcelona | Spain | Recruiting |
| Germans Trias i Pujol Hopital | Barcelona | Spain | Recruiting |
| Hospital de Belvitge | Barcelona | Spain | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05437900 on ClinicalTrials.gov ↗ ← All trials in China