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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7292   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-002161-27
    Sponsor's Protocol Code Number:DUETII01
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-02-23
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-002161-27
    A.3Full title of the trial
    Dutch randomized trial comparing Ultrasound-accElerated Thrombolysis with standard dose Urokinase versus half dose Urokinase for thrombo-embolic infra-inguinal arterial disease (DUET II)
    Nederlands gerandomiseerd onderzoek om het effect van echogeluid geassisteerde thrombolyse met standaard dosis Urokinase te vergelijken met echogeluid geassisteerde thrombolyse met de halve dosis Urokinase bij thrombo-embolische infra-inguinale arteriële ziekte (DUET II)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study in which ultrasound in combination with 2 different doses of declotting medicine (Urokinase) in patients with acute obstructed arteries or bypasses in the legs will be compared.
    Studie waarbij echogeluid in combinatie met stolseloplosmedicijn (Urokinase) in 2 verschillende doseringen voor stolseloplossing van afgesloten beenslagaderen en bypasses in het been wordt vergeleken.
    A.3.2Name or abbreviated title of the trial where available
    DUET II
    A.4.1Sponsor's protocol code numberDUETII01
    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 SponsorSint Antonius Hospital
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDutch Endovascular ALLiance (DEALL)
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSint Antonius Hospital
    B.5.2Functional name of contact pointI.M. van Dop
    B.5.3 Address:
    B.5.3.1Street AddressKoekoekslaan 1
    B.5.3.2Town/ cityNieuwegein
    B.5.3.3Post code3435 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31883208081
    B.5.6E-maili.van.dop@antoniusziekenhuis.nl
    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 Urokinase
    D.2.1.1.2Name of the Marketing Authorisation holdermedac Gesellschaft für klinische Spezialpräparate
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameMedacinase
    D.3.2Product code RVG 11730
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    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
    Acute thrombo-embolic occlusion of one of the infra-inguinal arteries
    Acute thrombo-embolische occlusie van een van infra-inguinale arteriën.
    E.1.1.1Medical condition in easily understood language
    Acute occlusion of one of the leg arteries
    Acute verstopping van een van de beenslagaders
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that the use of US-accelerated catheter-directed thrombolysis (EKOS EndoWave™) in patients with acute and sub-acute (less than 7 weeks) thrombosed infra-inguinal bypass grafts or native arteries with half the dose urokinase (50.000 I.U./h) will significantly reduce hemorrhagic complication rate compared with US-accelerated catheter-directed thrombolysis with the standard dose urokinase (100.000 I.U. /h) with comparable technical success rates.
    Om aan te tonen dat ultrageluid geassisteerde thrombolyse (EKOS Endowave™) in patiënten met acute en subacute occlusie van infra-inguinale bypass of natieve arterie met de halve dosis Urokinase (50.000 I.U./h) het aantal bloedingscomplicaties significant reduceert in vergelijking met de normale dosis Urokinase (100.000 I.U. /h) met dezelfde technische succes percentages.
    E.2.2Secondary objectives of the trial
    Effectiveness of lower dose Urokinase, also compared to duration of treatment and the total units of Urokinase needed to treat.
    Effectiviteit van lagere dosis Urokinase, in vergelijking met de duur van de behandeling en het totaal eenheden van Urokinase.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with acute and sub-acute (less than 7 weeks) thrombosed femoro-popliteal or femoro-crural native arteries with ischemic complaints.
    2. Patients with acute and sub-acute (less than 7 weeks) thrombosed femoro-popliteal or femoro-crural venous or prosthetic bypass grafts with ischemic complaints.
    3. Limb ischemia class I and IIa according to the Rutherford classification.
    4. Patients >18 years and <85 years old.
    5. Patients understand the nature of the procedure and provide written informed consent, prior to enrolment in the study
    1. Patiënten met acute en sub-acute (minder dan 7 weken) gethromboseerde femoro-popliteale of femoro-crurale natieve arterie met ischemische klachten.
    2. Patiënten met acute en sub-acute (minder dan 7 weken) gethromboseerde femoro-popliteale of femoro-crurale veneuze of prothese bypass met ischemische klachten.
    3. Perifere ischemie klasse I en IIa volgens de Rutherford classificatie.
    4. Patienten >18 jaar en <85 jaar oud.
    5. Patienten die de procedure kunnen begrijpen en zelf geschreven informed consent kunnen geven, voordat de studie wordt gestart.
    E.4Principal exclusion criteria
    1. Patients with isolated common femoral artery thrombosis including the origin of the superficial femoral artery and profunda femoral artery
    2. Patients with clinical complaints of lower limb ischemia due to thrombosis of femoro-popliteal or femoro-crural native arteries or femoro-popliteal and femoro-crural bypass grafts >7 weeks
    3. Patients with acute lower limb ischemia class IIb and III according to the Rutherford classification
    4. Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
    5. Recent (< 6 weeks) ischemic stroke or cerebral bleeding
    6. Patients with recent (<6 weeks) surgery
    7. Severe hypertension (diastolic blood pressure >110 mmHg, systolic blood pressure >200 mmHg)
    8. Current malignancy
    9. Patients with a history of prior life-threatening contrast medium reaction
    10. Patients with uncorrected bleeding disorders (GI ulcera, mennorrhagia, liver failure)
    11. Female patients of child bearing age not taking adequate contraceptives or currently breastfeeding
    12. Pregnancy
    13. Any patient considered being hemodynamically unstable at onset of procedure
    14. Patients refusing treatment
    15. Patients currently participating in another investigational drug or device study that have not completed the entire follow up period
    16. Patients < 18 years or >85 years old
    17. Severe co-morbid condition with life expectancy < 1 month
    1. Patiënten met een geïsoleerde afsluiting van de AFC inclusief de origo van de AFS en AFP.
    2. Patiënten met langer dan 7 weken bestaande ischemische klachten.
    3. Ischemische klachten in de categorie IIb of III volgens de acute Rutherford classificatie van acute ischemie.
    4. Patiënten bij wie een contra-indicatie bestaat voor trombocyten-aggregatieremmers, anti-coagulantia of trombolytica.
    5. Patiënten die recent (< 6 weken) een chirurgische interventie hebben ondergaan.
    6. Ernstige hypertensie (diastolische bloeddruk >110 mmHg of systolische bloeddruk >200 mmHg).
    7. Maligniteit.
    8. Recente (<6 weken) ischemische beroerte of hersenbloeding.
    9. Patiënten die in het verleden een levensbedreigende reactie op contrastmiddel hebben gehad.
    10. Patiënten die een niet-corrigeerbare bloedingsstoornis hebben (gastro-intestinaal ulcus, mennorrhagie, leverfalen)
    11. Vrouwelijke patiënten die een zwangerschapswens hebben of borstvoeding geven.
    12. Zwangerschap.
    13. Patiënten die hemodynamisch instabiel zijn bij aanvang van behandeling.
    14. Patiënten die behandeling weigeren.
    15. Patiënten die deelnemen aan een ander onderzoek naar geneesmiddelen of medische hulpmiddelen, waarvan de follow-up nog niet voltooid is.
    16. Patiënten < 18 of > 85 jaar.
    17. Ernstige comorbiditeit met een levensverwachting <1 maand.
    E.5 End points
    E.5.1Primary end point(s)
    Thrombolysis induced hemorrhagic complications.
    Bloedingscomplicaties geinduceerd door de thrombolyse.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During treatment
    Tijdens behandeling
    E.5.2Secondary end point(s)
    1. Technical success defined as >95% lysis of thrombus within 48 hours
    2. Duration of catheter-derived thrombolysis needed for uninterrupted flow in the thrombosed infra-inguinal bypass graft with outflow via at least one crural artery
    3. Amount of Urokinase (in IU) needed for uninterrupted flow
    4. 30-day mortality
    5. 30-day patency of the target artery or bypass, as evidenced by Colour Flow Doppler Ultrasound (Duplex)
    6. Conversion to open surgery
    7. Distal thrombo-embolic complications
    1. technisch succes, gedefinieerd als >95% lysis van de thrombus binnen 48uur.
    2. duur van de behandeling voordat de flow hersteld is naar tenminste ook 1 crurale arterie.
    3. totale hoeveelheid Urokinase in I.U. voordat de flow hersteld is.
    4. 30 dagen mortaliteit
    5. 30 dagen patency van de behandelde arterie of bypass, bewezen door duplex onderzoek.
    6. conversie naar open chirurgie.
    7. distale thromboembolische complicaties.
    E.5.2.1Timepoint(s) of evaluation of this end point
    during the treatment and at follow-up visit 30 days after treatment.
    tijdens de behandeling en bij controle bezoek 30 dagen na de behandeling.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    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
    other dose of same medicine
    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 concerned6
    E.8.5The trial involves multiple Member States No
    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 Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 62
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 62
    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 state124
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Dutch Endovascular ALLiance (DEALL)
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-15
    P. End of Trial
    P.End of Trial StatusOngoing
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