The REAL Registry for Utilization of iFR in Assessing Coronary Stenoses

Completed

• Conditions: Coronary Disease
• Interventions: Device: iFR/FFR

• Registration Number: NCT02281110
• Lead Sponsor: Volcano Corporation

Brief 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.

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 Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-10-01
• Study First Submitted QC: 2014-10-31
• Study First Posted: 2014-11-02
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-09
• Last Update Posted: 2016-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
iFR/FFR assessment	iFR/FFR	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.

Primary Outcome Measures

Name	Time	Method
Hemodynamic severity (Percentage of stenosis properly classified by iFR®)	Day 1 (Post-Procedure)	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.

Secondary Outcome Measures

Name	Time	Method
changes in iFR® and FFR	Day 1 (Post-Procedure)	Changes in iFR® and FFR pre angioplasty and post angioplasty in MVD patients.
Changes to decision strategy of revascularization	Day 1 (Post-Procedure)	Percentage of MVD patients in whom the decision strategy of revascularization changed after iFR® compare to the decision based on diagnostic angiogram only.

Trial Locations

Locations (1)

Volcano Europe BVBA/SPRL; 🇧🇪 Zaventem, Belgium