A comparison of two different methods of performing a fractional flow reserve (FFR) procedure in patients requiring a routine coronary angiogram , one using a new micro catheter and one using the standard method

Phase 1

• Conditions: This is a single-blind, randomised, crossover investigation comparing the investigational device using intra-coronary (IC) Adenosine infusion to the standard intravenous (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.; MedDRA version: 18.1 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2016-000388-18-GB
• Lead Sponsor: Diasolve Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-07
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 44

Inclusion Criteria

1.Ability and willingness to give written informed consent prior to investigation participation.

2.Has given consent to undergo hospital’s diagnostic or interventional coronary procedure.

3.Male or female subject aged 18 and over.

4.Ability to communicate well with the investigator and to comply with the requirements of the clinical investigation.

Prior to randomisation:

1.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.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 29

Exclusion Criteria

1.Known sensitivity to adenosine or any of its excipients

2.Technically inaccessible stenosis(es)

3.Acute ST segment elevation myocardial infarction (STEMI)

4.Haemodynamically unstable

5.Presence of any clinically significant medical condition as determined by the investigator

6.Pregnancy, including the intention or possibility of becoming pregnant prior to the investigation

7.Participation in another clinical investigation within the three months prior.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified