The REAL Registry for Utilization of iFR in Assessing Coronary Stenoses (DEFINE REAL)

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.

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.

Study Overview

• Status: Completed
• Conditions: Coronary Disease
• Intervention / Treatment: Device: iFR/FFR

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Belgium
  • Zaventem, Belgium, 1930
    • Volcano Europe BVBA/SPRL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Eligibility includes adults undergoing coronary angiography and/or PCI

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

iFR/FFR assessment; Patients enrolled into this prospective registry will be derived from Stable Coronary Artery disease or Acute Coronary Syndrome (ACS) population undergoing cardiac catheterization. Patients with ACS may be evaluated by functional assessment in the non-culprit stenosis during the index PCI revascularization or in a staged procedure. The registry will enroll patients in whom physiological assessment (iFR/FFR) is particularly helpful in identifying haemodynamically significant stenosis: MVD patients defined by patients with lesions > 40% and <100% in 2 or more vessels.

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.; Other Names: instant flow reserve/fractional flow reserve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in iFR® and FFR	Changes in iFR® and FFR pre angioplasty and post angioplasty in MVD patients.	Day 1 (Post-Procedure)
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)

Collaborators and Investigators

• Sponsor: Volcano Corporation

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 1, 2014
• First Submitted That Met QC Criteria: October 31, 2014
• First Posted (Estimate): November 2, 2014

Study Record Updates

• Last Update Posted (Estimate): May 10, 2016
• Last Update Submitted That Met QC Criteria: May 9, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Fractional flow reserve; Diagnostic coronary catheterization; Multi-vessel coronary disease; Instantaneous wave free ratio
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Coronary Disease; Coronary Stenosis
• Other Study ID Numbers: 2014-CV-001