INSIGHTFUL-FFR Clinical Trial

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

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.

Sponsors & Collaborators

• Insight Lifetech Co., Ltd.

  collaborator INDUSTRY

• CoreAalst BV

  lead INDUSTRY

Principal Investigators

• Emanuele Barbato, MD, PhD · Azienda Ospedaliera Universitaria Sant'Andrea, Roma

• Carlos Collet, MD, PhD · CoreAalst BV

• Junbo Ge, MD · Zhongshan Hospital, Fudan University, Shanghai

• Salvatore Brugaletta, MD, PhD · Hospital Clinic of Barcelona

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-22

Primary Completion

2026-06-30

Completion

2030-06-30

Countries

• Belgium
• China
• France
• Germany
• Italy
• Netherlands
• Poland
• Spain

Study Locations