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

NCT02527616 | Completed

• 1 other identifier: DIAS-001-FFR
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Number of participants with comparable FFR ratio recordings

  The FFR ratio should remain constant when measured by the standard method and the investigational device.

  Intraoperative

Secondary Outcomes (3)

• Number of participants with Adverse Events

  Intraoperative

• Dose of adenosine administered.

  Intraoperative

• Time to onset of maximum hyperaemia.

  Intraoperative

Study Arms (2)

IV followed by IC (investigation)

EXPERIMENTAL

The patient undergoes the FFR measurement with the standard measurement first followed by FFR measurement using the FFR Infusion Microcatheter

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

IC (investigation) followed by IV

EXPERIMENTAL

The patient undergoes the FFR measurement using the FFR Infusion Microcatheter measurement first followed by measurement via the standard measurement

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

Interventions

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

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

Also known as: HYPEREM™IC, REF: 143836-01 GTIN: 5060420320008., HYPERAEM

IC (investigation) followed by IV; IV followed by IC (investigation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability and willingness to give written informed consent prior to investigation participation.
• Has given consent to undergo hospital's diagnostic or interventional coronary procedure.
• Male and female subjects aged 18 and over.
• Ability to communicate well with the investigator and to comply with the requirements of the clinical investigation.
• Prior to randomisation:
• \. Coronary angiogram demonstrates at least one coronary stenosis of intermediate severity (40-70%), in a non-infarct related artery, which requires FFR measurement for physiological assessment.

You may not qualify if:

• Known sensitivity to adenosine or any of its excipients
• Technically inaccessible stenosis(es)
• Acute ST segment elevation myocardial infarction (STEMI)
• Haemodynamically unstable
• Presence of any clinically significant medical condition as determined by the investigator
• Participation in another clinical investigation within the three months prior.

Sponsors & Collaborators

• Diasolve Ltd: lead

Study Sites (1)

Northwick Park Hospital

Harrow, Middx, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ahmed Elghamaz, MB BCh, MRCP

  London North West Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

• Paul Wenberger

  Diasolve Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: August 19, 2015
• Study Start: May 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 14, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)