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    Summary
    EudraCT Number:2016-000388-18
    Sponsor's Protocol Code Number:DIAS-001-FFR
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-03-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2016-000388-18
    A.3Full title of the trial
    A randomised crossover investigation to evaluate and compare the effectiveness, safety and feasibility of a novel dedicated Over-The-Wire FFR Infusion MicroCatheter (HYPEREM IC) for measuring fractional flow reserve (FFR) using intra-coronary non-weight adjusted adenosine infusion with the standard intra-venous administration of adenosine, in subjects with intermediate coronary artery stenosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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
    A.3.2Name or abbreviated title of the trial where available
    A Clinical Investigation to Evaluate the HYPEREM™IC catheter v2
    A.4.1Sponsor's protocol code numberDIAS-001-FFR
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02527616
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDiasolve Ltd
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDiasolve Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDiasolve Ltd
    B.5.2Functional name of contact pointPaul Weinberger
    B.5.3 Address:
    B.5.3.1Street Address114 Tetricus Science Park
    B.5.3.2Town/ cityDSTL Porton Down, Salisbury
    B.5.3.3Post codeSP4 0JQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number44 1980 611534
    B.5.6E-mailpaul.weinberger@diasolve.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Adenosine
    D.2.1.1.2Name of the Marketing Authorisation holderFocus Pharmaceuticals Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAdenosine
    D.3.2Product code NA
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracoronary use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAdenosine
    D.3.9.1CAS number na
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive namena
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3 to mg/ml
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    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.
    E.1.1.1Medical condition in easily understood language
    Patients who are having coronary angiography will be asked if they are happy to take part in a trial comparing 2 ways of finding out if an artery narrowing is causing their symptoms.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10011078
    E.1.2Term Coronary artery disease
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to demonstrate the use of the investigation device using intra coronary adenosine infusion results in non-inferior FFR measurements when assessing intermediate stenoses, when compared to the standard method of assessment using intravenous adenosine.
    E.2.2Secondary objectives of the trial
    •To demonstrate that the investigational device with the use of intracoronary adenosine
    infusion is a safe method of performing FFR measurements

    •To demonstrate that the investigational device achieves maximal hyperaemia (i.e. increased
    coronary blood flow) with a reduced dose of adenosine

    •To demonstrate that the investigational device requires a shorter duration of adenosine
    administration to achieve maximal hyperaemia
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary end point(s)
    Primary objective: To demonstrate that use of the investigational device results in non-inferior FFR measurements compared to the current standard procedure.

    Primary endpoint: FFR measurements will be taken following advancement of the pressure wire to the desired location (FFR= PD (pressure distal to the stenosis) / PA (pressure proximal to the stenosis). Continuous FFR measurements will be recorded during the adenosine infusion until the FFR reaches a steady state of hyperaemia. Once this has been achieved, the mean FFR readings will be recorded.

    FFR measurements will be performed twice for each stenosis to be studied: once using the IVSTD and once using the ICINV. Each subject will undergo both procedures, and the order in which they receive them will be randomised. Subjects will be blinded to the order in which they receive the procedures.

    Effectiveness will be measured using the FFR measurements. All subjects with FFR measurements for both procedures will be evaluable for this endpoint. Subjects will be analysed according to their randomised sequence and the analysis will be repeated treating subjects as per their received sequence if there are deviations from the planned randomised order.

    For each subject the difference in FFR (FFRDIFF) will be calculated as FFRINV minus FFRSTD. Mean FFRDIFF will be reported with standard deviation of the difference and a 95% confidence interval. A scatterplot will be used to show the FFR measurements from the investigational device versus the standard method with a line of perfect agreement. The ICINV device will be considered non-inferior to the IVSTD if the upper limit of the two-sided 95% confidence interval for FFRDIFF is less than 0.05.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Endpoints will be evaluated at the end of the study
    E.5.2Secondary end point(s)
    • Incidence and severity of expected side effects (i.e. chest discomfort as measured on a subject-rated discomfort scale of 1-4, and bradycardia and atrioventricular block noted by investigator as present or absent)

    • Incidence, nature, severity and duration of adverse events (excluding expected side effects)

    • Time to reach maximum hyperaemia

    • Total adenosine dose required

    • Total duration of adenosine administration

    • Failure to achieve maximum hyperaemia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    They will be evaluated at the end of the study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Adenosine IV infusion
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    The end of the trial is when the last patient has completed their last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 29
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 44
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The trial will be completed in 1 day. It is not expected that any additional care will be required over and above that of any patient undergoing a coronary angiogram.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-03-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-11-18
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