INSIGHTFUL-FFR Clinical Trial
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-85
SponsorCoreAalst BV
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
The subject must be at least 18 years of age and younger than 85 years old.
Eligible for elective PCI.
Stable angina or ACS (non-culprit vessels only and outside of primary intervention during acute STEMI)
Subject willing to participate and able to understand, read and sign the Informed Consent.
Disqualifiers
STEMI as clinical presentation.
Chronic total occlusion as a target vessel.
Significant contraindication to adenosine administration (e.g. heart block, severe asthma)
Uncontrolled or recurrent ventricular tachycardia.
Trial design
Design model
Parallel
Treatments tested in this trial
Pressure Microcatheter guided strategy - PIOS MC
Procedure/SurgeryUse 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
Procedure/SurgeryUse 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
Procedure/SurgeryUse of Pressure Microcatheter during PCI. After the PCI, the patient will receive standard of care treatment.
Pressure Wire guided strategy - Standard of care
Procedure/SurgeryUse of Pressure Wire during PCI. After the PCI, the patient will receive standard of care treatment.
Treatment groups
2,500 Participants
are divided into 4 treatment groupsGroup A: Pressure Microcatheter guided strategy - PIOS-MCExperimental treatment 1 intervention
Group B: Pressure Wire guided strategy - PIOS-PWActive comparator 1 intervention
Group C: Pressure Microcatheter guided strategy - Standard of careExperimental treatment 1 intervention
Group D: Pressure Wire guided strategy - Standard of careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Compare the rate of MACE between pressure microcatheter and pressure wire strategies.
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.
Time frame
12 Months follow-upSecondary outcomes
1
Compare the rate of target vessel failure (TVF) between PIOS and SOC.
In patients undergoing PCI, compare the rate of target vessel failure (TVF) defined as the composite of cardiac death, target vessel MI and ischemia-driven target vessel revascularisation (ID-TVR) between PIOS and SOC.
Time frame
12 Months follow-up2
Compare in-hospital resource utilization between pressure microcatheter and pressure wire strategies.
Compare in-hospital resource utilisation (cost from all the procedures during the hospitalisation to discharge in Euros) between microcatheter and pressure wire strategies i.e.number of pressure catheters/wires and procedural time needed to complete the procedure.
Time frame
During the hospitalisation (from admission to the hospital until discharge after the procedure)3
Compare the procedure time between pressure microcatheter and pressure-wire guided strategies in minutes.
Compare the procedure time between pressure microcatheter and pressure-wire guided strategies in minutes. This is the time from first to the last angiography in minutes.
Time frame
Periprocedural time frame4
Compare in-hospital resource utilisation between PIOS-MC and PIOS-PW.
In patients undergoing PCI, compare resource utilisation (cost from all the procedures during the hospitalisation to discharge in Euros, e.g. number of catheters/wires) between a pressure PIOS-MC and PIOS-PW strategies in patients undergoing PCI.
Time frame
During the hospitalisation (from admission to the hospital until discharge after the procedure)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
CoreAalst BV
Lead sponsor
Insight Lifetech Co., Ltd.
Collaborator
Source ClinicalTrials.gov