NCT05437900

INSIGHTFUL-FFR Clinical Trial

Pressure Microcatheter vs Pressure Wire for Clinical Decision Making and PCI Optimization

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,500 (estimated)
• Sponsor: CoreAalst BV · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-22
• Primary completion: 2026-06-30
• Completion: 2030-06-30
• First posted: 2022-06-29
• Last updated: 2026-01-12

Locations

29 sites across 8 countries: Belgium, China, France, Germany, Italy, Netherlands, Poland, Spain