Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02281110
Recruitment Status : Completed
First Posted : November 3, 2014
Last Update Posted : May 10, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Coronary Disease 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.


Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
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.
Study Start Date : July 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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 Name: instant flow reserve/fractional flow reserve




Primary Outcome Measures :
  1. Hemodynamic severity (Percentage of stenosis properly classified by iFR®) [ Time Frame: 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 :
  1. changes in iFR® and FFR [ Time Frame: Day 1 (Post-Procedure) ]
    Changes in iFR® and FFR pre angioplasty and post angioplasty in MVD patients.

  2. Changes to decision strategy of revascularization [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligibility includes adults undergoing coronary angiography and/or PCI
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281110


Locations
Layout table for location information
Belgium
Volcano Europe BVBA/SPRL
Zaventem, Belgium, 1930
Sponsors and Collaborators
Volcano Corporation

Additional Information:

Layout table for additonal information
Responsible Party: Volcano Corporation
ClinicalTrials.gov Identifier: NCT02281110     History of Changes
Other Study ID Numbers: 2014-CV-001
First Posted: November 3, 2014    Key Record Dates
Last Update Posted: May 10, 2016
Last Verified: May 2016

Keywords provided by Volcano Corporation:
Diagnostic coronary catheterization
Multi-vessel coronary disease
Percutaneous Coronary Intervention
Instantaneous wave free ratio
Fractional flow reserve

Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Disease
Coronary Artery Disease
Coronary Stenosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases