The REAL Registry for Utilization of iFR in Assessing Coronary Stenoses (DEFINE REAL)
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|ClinicalTrials.gov Identifier: NCT02281110|
Recruitment Status : Completed
First Posted : November 3, 2014
Last Update Posted : May 10, 2016
|Condition or disease||Intervention/treatment|
|Coronary Disease||Device: iFR/FFR|
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 [Patient Registry]|
|Actual Enrollment :||500 participants|
|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|
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.
• 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
- 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.
- changes in iFR® and FFR [ Time Frame: Day 1 (Post-Procedure) ]Changes in iFR® and FFR pre angioplasty and post angioplasty in MVD patients.
- 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.
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
|Volcano Europe BVBA/SPRL|
|Zaventem, Belgium, 1930|