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

Status: Recruiting
Location: See all (31) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
OLV Aalst
RECRUITING
Aalst
Universitair ziekenhuis Brussel
RECRUITING
Brussels
ZOL
RECRUITING
Genk
China
QILU Hospital of Shandong University
NOT_YET_RECRUITING
Shandong
Zhongshan Hospital of Fudan University
RECRUITING
Shanghai
West China Hospital of Sichuan University
RECRUITING
Sichuan
France
CHU Lille
RECRUITING
Lille
Claude Bernard University
RECRUITING
Lyon
ICPS
RECRUITING
Paris
Germany
Herzzentrum Dresden
NOT_YET_RECRUITING
Dresden
Klinikum Fürth
RECRUITING
Fürth
Klinikum Herford
RECRUITING
Herford
Catholic Medical Center Koblenz-Montabaur
RECRUITING
Koblenz
Herzzentrum Lahr
RECRUITING
Lahr
Universitätsklinik
RECRUITING
Mainz
Italy
Nuovo Arcispedale S.Anna Di Ferrara
RECRUITING
Ferrara
Ospedale Civile Sant'Andrea
RECRUITING
La Spezia
Ospedale Santa Maria Goretti
RECRUITING
Latina
Azienda Ospedaliera Universitaria Federico II
RECRUITING
Naples
Azienda Ospedaliera Universitaria Sant'Andrea
RECRUITING
Rome
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Catharina Ziekenhuis
NOT_YET_RECRUITING
Eindhoven
UMCN Radboud
RECRUITING
Nijmegen
Poland
Dr. Jurasz University Hospital No. 1
RECRUITING
Bydgosz
John Paul II Specialistic Hospital
RECRUITING
Krakow
Uniwersitecki Szpital Kliniczny w Poznan
NOT_YET_RECRUITING
Poznan
MSWIA Hospital Rzeszow
NOT_YET_RECRUITING
Rzeszów
National Cardiac Institute
RECRUITING
Warsaw
Spain
Germans Trias i Pujol Hopital
RECRUITING
Barcelona
Hospital Clínic Barcelona
RECRUITING
Barcelona
Hospital de Belvitge
RECRUITING
Barcelona
Contact Information
Primary
Sofie Pardaens
sofiepardaens@coreaalst.com
0032 53 72 42 30
Time Frame
Start Date: 2022-09-22
Estimated Completion Date: 2030-06-30
Participants
Target number of participants: 2500
Treatments
Experimental: Pressure Microcatheter guided strategy - PIOS-MC
Patients will be treated with the Pressure Microcatheter during PCI. After completing an angiographically successful PCI, patients will be randomized to FFR-guided stent optimization (PIOS).
Active_comparator: Pressure Wire guided strategy - PIOS-PW
Patients will be treated with the Pressure Wire during PCI. After completing an angiographically successful PCI, patients will be randomized to FFR-guided stent optimization (PIOS).
Experimental: Pressure Microcatheter guided strategy - Standard of care
Patients will be treated with the Pressure Microcatheter during PCI. After completing an angiographically successful PCI, patients will receive the standard of care treatment.
Active_comparator: Pressure Wire guided strategy - Standard of care
Patients will be treated with the Pressure Wire during PCI. After completing an angiographically successful PCI, patients will receive the standard of care treatment.
Sponsors
Collaborators: Insight Lifetech Co., Ltd.
Leads: CoreAalst BV

This content was sourced from clinicaltrials.gov