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    Summary
    EudraCT Number:2014-003469-10
    Sponsor's Protocol Code Number:MUST14
    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:2015-07-09
    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 number2014-003469-10
    A.3Full title of the trial
    The application of contrast-enhanced ultrasound to facilitate thrombolysis in patients with acute peripheral arterial occlusions.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ultrasound with contrast as additional treatment for blocked arteries in the lower limb.
    A.3.2Name or abbreviated title of the trial where available
    MUST Trial
    A.4.1Sponsor's protocol code numberMUST14
    A.5.4Other Identifiers
    Name:NTRNumber:TC=4731
    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 SponsorVU University Medical Center
    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 supportLamepro
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU University Medical Center
    B.5.2Functional name of contact pointHead Investigator
    B.5.3 Address:
    B.5.3.1Street AddressBoelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HV
    B.5.3.4CountryNetherlands
    B.5.6E-mailk.yeung@vumc.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Luminity
    D.2.1.1.2Name of the Marketing Authorisation holderLantheus MI UK Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameLuminity
    D.3.2Product code EMEA/H/C/000654
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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.IMP: 2
    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 medacinase
    D.2.1.1.2Name of the Marketing Authorisation holderMedac
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameurokinase
    D.3.2Product code 9039-53-6
    D.3.4Pharmaceutical form Powder 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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 peripheral arterial occlusions. Acute peripheral arterial occlusive disease can be caused by a blood clot blocking an artery in an arm or leg. This is an emergency situation that can result in amputation or be life threatening if not treated promptly.
    E.1.1.1Medical condition in easily understood language
    A disease in which a blood clot blocks an artery of the leg.
    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
    The primary objective is to test whether thrombolysis with additional contrast-enhanced ultrasound is applicable in patients with peripheral arterial occlusions.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to investigate the safety of microbubble and ultrasound enhanced intra-arterial thrombolysis and if it is logistically feasible in our university hospital.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Men and women older than 18 years and younger than 85 years old
    • Patients with a maximum of 7 weeks complaints due to lower limb ischemia due to
    thrombosed/occluded iliofemoral, femoropopliteal or femorocrural native arteries or femoropopliteal or
    femorocrural venous or prosthetic bypass grafts
    • Anatomic suitability duplex ultrasound in case of iliac occlusion
    • Patients fit for thrombolysis i.e. with acute lower limb ischemia class I and IIa according to the
    Rutherford classification (see attachment II)
    • Patients understand the nature of the procedure and provide written informed consent before enrolment
    in the study
    E.4Principal exclusion criteria
    • Patients with clinical complaints of acute lower limb ischemia due to thrombosis of the iliofemoral, femoropopliteal or femorocrural native arteries, or femoropopliteal or femorocrural venous or prosthetic bypass grafts more than 7 weeks
    • Patients with iliac occlusions anatomically not suitable for duplex ultrasound
    • Patients with thrombosed popliteal aneurysms
    • Patients with contra-indications for the administration of antiplatelet therapy, anticoagulants or thrombolytics
    • Recent (less than 6 weeks) ischemic stroke, cerebral bleeding or myocardial infarction
    • Patients with recent (less than 6 weeks) surgery
    • Severe hypertension (diastolic blood pressure greater than 110 mm Hg, systolic blood pressure higher than 200 mm Hg)
    • Current malignancy or severe comorbid condition with a life expectancy of less than 6 months
    • Patients with uncorrected bleeding disorders (gastrointestinal ulcer, menorrhagia, liver failure)
    • Women with child-bearing potential not taking adequate contraceptives or currently breastfeeding
    • Pregnancy
    • Patients who are currently participating in another investigational drug or device study
    • Patients younger than 18 years or older than 85 years
    • Patients with contra-indications for Luminity microbubbles i.e.
    • Hypersensitivity to sulphur hexafluoride or to any of the components of Luminity,
    • Recent acute coronary syndrome or clinically unstable ischemic cardiac disease, including: evolving or ongoing myocardial infarction, typical angina at rest within last 7 days, significant worsening of cardiac symptoms within last 7 days, recent coronary artery intervention or other factors suggesting clinical instability (for example, recent deterioration of ECG, laboratory or clinical findings), acute cardiac failure, Class III/IV cardiac failure, or severe rhythm disorders
    • Patients known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure >90 mmHg), uncontrolled systemic hypertension, and in patients with adult respiratory distress syndrome.
    E.5 End points
    E.5.1Primary end point(s)
    Main endpoints will be the duration of thrombolysis needed for uninterrupted flow in the thrombosed native artery or bypass graft with outflow through at least 1 crural artery and microcirculation of the lower limb as measured by Laser Doppler Flowmetry on the skin of the lower limb. Furthermore, Severe Adverse Events (haemorrhagic complications, allergic reactions, in hospital mortality directly related to the treatment) and amputation-free rate at 6 months.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Duration of thrombolysis: at cessation of therapy: ultrasound duplex every 6 hours, SAE's during hospital stay, amputation-free rate at 6 months.
    E.5.2Secondary end point(s)
    Secondary endpoints will be the angiographic success rate, microcirculatory flow, distal thromboembolic complications, other complications, 30 day mortality rate, conversion to open surgery, duration of hospital admission, serum fibrinogen concentrations, pain scores and quality of life.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Angiographic success rate at last angiography before treatment cessation, complications during hospital stay, mortality rate at 30 days, conversion to open surgery during thrombolytic therapy, serum fibrinogen concentrations during thrombolytic therapy, ultrasound duplex and microcirculatory flow every 6 hours during treatment, pain scores before treatment initiation, every three hours during thrombolytic treatment and follow-up at 3 months, 6 months and 1 year, quality of life at baseline (before treatment initiation), and during follow-up at 3 months, 6 months and 1 year.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    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 No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    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 Yes
    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 state20
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-02
    P. End of Trial
    P.End of Trial StatusOngoing
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