NCT02281110

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 3, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 10, 2016

Status Verified

May 1, 2016

Enrollment Period

1.4 years

First QC Date

October 1, 2014

Last Update Submit

May 9, 2016

Conditions

Coronary Disease

Keywords

Diagnostic coronary catheterizationMulti-vessel coronary diseasePercutaneous Coronary InterventionInstantaneous wave free ratioFractional flow reserve

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • changes in iFR® and FFR

    Day 1 (Post-Procedure)

  • Changes to decision strategy of revascularization

    Day 1 (Post-Procedure)

Study Arms (1)

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

Interventions

iFR/FFRDEVICE

• 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.

Also known as: instant flow reserve/fractional flow reserve
iFR/FFR assessment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eligibility includes adults undergoing coronary angiography and/or PCI

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Volcano Europe BVBA/SPRL

Zaventem, 1930, Belgium

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2014

First Posted

November 3, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 10, 2016

Record last verified: 2016-05

Locations

BE(1)