The REAL Registry for Utilization of iFR in Assessing Coronary Stenoses

Coronary Disease Clinical Trial

— DEFINE REAL  

Official title:

A Prospective, Observational, Non-randomized European, Multi-center Registry Collecting Real Life Information for the Utilization of Instantaneous Wave Free Ratio in Assessing Coronary Stenosis Relevance in the Multi-vessel Disease Patients Population.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02281110
• Other study ID #: 2014-CV-001
• Status: Completed
• Phase: N/A
• First received: October 1, 2014
• Last updated: May 9, 2016
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: May 2016
• Source: Volcano Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionFrance: Conseil National de l'Ordre des MédecinsFrance: Commission nationale de l'informatique et des libertésFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéGermany: Ethics CommissionItaly: Ethics CommitteeNetherlands: Medical Ethics Review Committee (METC)Poland: Ethics CommitteeSaudi Arabia: Ethics CommitteeSlovenia: Ethics CommitteeSpain: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this registry is to collect real life information and to document the performance and user friendliness of iFR in daily diagnostic practice and treatment strategies for MVD patients undergoing cardiac catheterization.

Description:

The REAL Registry will enroll a maximum of 3,000 patients in approximately 300 sites across multiple European and Middle East countries, where product has received CE approval and is marketed. An average of 10 cases with a maximum of 50 patients will be enrolled per participating site.

No follow-up will be performed. The REAL Registry will only collect data during diagnostic angiogram or PCI procedure, when performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 year of age

• Willing to participate and able to understand, read and sign the informed consent document before the planned procedure

• Eligible for coronary angiography and PCI

• Coronary artery disease with at least two or more visually assessed coronary stenoses (greater than 40% diameter stenosis) in native, major epicardial vessel or its branches by coronary angiogram with an indication of physiological assessment.

Exclusion Criteria:

• Inability to obtain a signed informed consent from potential patient.

• Any contraindication for functional assessment as per the instructions per use and determined by the investigator.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Stenosis

Intervention

Device:
• iFR/FFR
• The Volcano iFR®-FFR option, which is a measurement modality for the Volcano system that provides the capability to make FFR and instantaneous wave-Free Ratio™ (iFR®) measurements (CE-Marked). iFR® is a pressure-derived, hyperemia-free index for the assessment of coronary stenosis relevance. This option consists of an FFR-iFR® specific patient interface module (PIM-FFR) which can be connected to the Volcano system - VOLCANO s5 or s5i™ platform equipped with iFR® option. This PIM-FFR is compatible with all Volcano pressure measurement guide wires.

Locations

Country	Name	City	State
Belgium	Volcano Europe BVBA/SPRL	Zaventem

Sponsors (1)

Lead Sponsor	Collaborator
Volcano Corporation

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamic severity (Percentage of stenosis properly classified by iFR®)	Percentage of stenosis properly classified by iFR® in terms of hemodynamic severity compare to FFR in MVD patients. Hemodynamic severity will be established with an FFR value <=0,80.	Day 1 (Post-Procedure)	No
Secondary	changes in iFR® and FFR	Changes in iFR® and FFR pre angioplasty and post angioplasty in MVD patients.	Day 1 (Post-Procedure)	No
Secondary	Changes to decision strategy of revascularization	Percentage of MVD patients in whom the decision strategy of revascularization changed after iFR® compare to the decision based on diagnostic angiogram only.	Day 1 (Post-Procedure)	No