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An Investigation to Evaluate an Over-The-Wire FFR Infusion Microcatheter (HYPEREM™IC) for Measuring Fractional Flow Reserve (FFR)

NCT02527616 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2016-12-14

No results posted yet for this study

Summary

This is a single-blinded, randomised, crossover investigation comparing the investigational device using intra-coronary (IC) Adenosine infusion to the standard intra-venous (IV) infusion method used for obtaining FFR measurements. All subjects requiring on a clinical basis a pressure wire assessment of intermediate coronary artery stenosis(es) will be eligible to take part in the investigation.

Conditions

Interventions

DEVICE

FFR Infusion Microcatheter and standard intra-venous (IV) infusion

Cross-over design where FFR is measured twice in the same lesion using standard standard intra-venous (IV) infusion and new method

Sponsors & Collaborators

  • Diasolve Ltd

    lead INDUSTRY

Principal Investigators

  • Ahmed Elghamaz, MB BCh, MRCP · London North West Healthcare NHS Trust

  • Paul Wenberger · Diasolve Ltd

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02527616 on ClinicalTrials.gov