The REAL Registry for Utilization of iFR in Assessing Coronary Stenoses

NCT ID: NCT02281110

Last Updated: 2016-05-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-12-31

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.

Conditions

Coronary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

iFR/FFR

Intervention Type: DEVICE

• 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

instant flow reserve/fractional flow reserve

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Volcano Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Volcano Europe BVBA/SPRL

Zaventem, , Belgium

Countries

Belgium

Other Identifiers

2014-CV-001

Identifier Type: -

Identifier Source: org_study_id