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    Summary
    EudraCT Number:2014-003341-10
    Sponsor's Protocol Code Number:NL47979.091.14
    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:2014-11-19
    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 number2014-003341-10
    A.3Full title of the trial
    Registry of the treatment of primay insufficiency of the great saphenous
    vein with a diameter >/= 12 mm, anterolateral branches, or great
    saphenous vein insufficiency below the knee with mechano-chemical
    endovenous ablation (MOCA)
    Registratie studie van de behandeling van primaire insufficientie van de vena saphena magna met een diameter >/= 12 mm, anterolaterale takken, of een insufficiente vena saphena magna onder de knie met mechano-chemische
    endoveneuze ablatie (MOCA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Registry of the treatment of dilated veins with the Clarivein catheter. The
    procedure, ClariVein, involved a rotating catheter (a small tube inserted
    into the vein) and a drug that collapses the vein
    Registratie studie van de behandeling van spataders met de ClariVein latheter. De procedure, ClariVein, bestaat uit een ronddraaiende katherter (een smalle buis die in de ader wordt ingebracht) en een medicijn dat zorgt dat de ader samentrekt.
    A.3.2Name or abbreviated title of the trial where available
    MOCA-XL
    MOCA-XL
    A.4.1Sponsor's protocol code numberNL47979.091.14
    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 SponsorRijnstate
    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 supportRijnstate Hospital
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportSint Antonius Hospital
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportOnze Lieve Vrouwe Gasthuis
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportBovenij Hospital
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRijnstate
    B.5.2Functional name of contact pointMichel Reijnen
    B.5.3 Address:
    B.5.3.1Street AddressWagnerlaan 55
    B.5.3.2Town/ cityArnhem
    B.5.3.3Post code6800 TA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31880056909
    B.5.6E-mailmreijnen@rijnstate.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 Aethoxysklerol
    D.2.1.1.2Name of the Marketing Authorisation holderKreussler
    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 nameaethoxysklerol
    D.3.2Product code 50 EU 4087 K
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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 Yes
    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
    varicose veins of the infragenual great saphenous vein, large supragenual great saphenous vein (>= 12 mm) and antero-lateral branch varicose veins
    varices van de infragenuale vena saphena magna, grote supragenuale vena saphena magna(>= 12 mm) and antero-laterale zijtakken
    E.1.1.1Medical condition in easily understood language
    dilated veins
    spataderen
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    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 provide insight in the safety and efficay of treatment with the ClariVein device for primary insufficiency of the great saphenous vein (GSV) supragenual (>= 12 mm), insuffucient infragenual GSV, and antero-lateral branch insufficiency.
    Om inzicht in de veiligheid en effectiviteit van de behandeling met de e ClariVein bij de behandeling van primaire insufficientie van de vena saphena magna (VSM) supragenuaal (>= 12 mm), insuffuciente infragenuale VSM, en insufficiente antero-laterale zijtakken.
    E.2.2Secondary objectives of the trial
    per-operative pain measured with the VAS score. Post-operative pain during the first two weeks. Disease specific and general healt questionnaires. Time to resume daily activities and work. Intervention duration.
    per-operatieve pijn score gemeten op de VAS pijnscore schaal. Post-operatieve pijn gedurende de eerste wee weken na behandeling. Ziekte specifieke en algemene gezondheids vragenlijsten. Tijd tot herstel van de dagelijkse activiteiten en werk. Duur van de interventie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Symptomatic varicose veins, C2-C5
    2.Ultrasound criteria:
    a.Diameter supragenual great saphenous vein (GSV) >/= 12 mm , not tortuouss; or
    b.Insufficient antero-lateral branch; or
    c.Insufficient below knee GSV
    3.Signed informed consent
    4.Patient consents to follow-up
    5.Age > 18 year en < 80 year
    1.Symptomatische varics, C2-C5
    2.Duplex criteria:
    a.Diameter supragenuale VSM >/= 12 mm , niet tortueus; of
    b.Insufficiente antero-laterale zijtak; of
    c.Insufficiente infragenuale VSM
    3. Getekend informed consent
    4. Patiënt bereid to volgen van follow-up plan
    5. Leeftijd > 18 jaar en < 80 jaar
    E.4Principal exclusion criteria
    1.Patient is not capable to provide informed consent
    2.Pregnancy and lactation
    3.C6 varicose veins
    4.Previous surgery or endovenous ablation at to treated segment
    5.Deep venous vein thrombosis in medical history
    6.Oral anti-coagulant therapy
    7.Contra-indications or allergy for sclerosant
    8.Immobilisation
    9.Coagulant disorders or increaased risk for thrombo-embolic complications: known coagulant disorders such as hemofilia A, hemofilia B, Von Willebrand disease, Glanzmann disease, factor VII-deficiency, idiopathic thrombo-cytopenic purpura, factor V Leiden disease and deep venous thrombosis or lung emboli in medical history
    10.Fontaine III of IV peripheral arterial disease
    11.Severe kidney disease: known GFR < 30 ml/min.
    12. Liver diseases accompanied by changes in coagulation of the blood, anamnistic indications for tendency towards haemorrhage , such as epistaxis and spontanuous hematoma, known liver cirrhosis.
    1.Patiënt is niet in staat tot informed consent
    2.Zwangerschap en lactatie
    3.C6 varices
    4.Eerdere chirurgische of endoveneuze behandeling van varices van de VSM van het te behandelen been
    5.Doorgemaakte diep veneuze trombose
    6.Orale anticoagulantia
    7.Contra-indicaties of allergie voor gebruik sclerosans
    8.Immobilisatie
    9.Stollingsstoornissen of een verhoogd risico op trombo-embolische complicaties: bekende stollingsstoornissen zoals hemofilie A, hemofilie B, ziekte van Von Willebrand, ziekte van Glanzmann, factor VII-deficiëntie, idiopathische trombo-cytopenische purpura, aanwezigheid factor V Leiden en diep veneuze trombose of longembolie in de voorgeschiedenis.
    10.Fontaine III of IV vaatlijden
    11.Ernstig gestoorde nierfunctie: bekende glomerulaire filtratie snelheid van minder dan 30 ml/min.
    12. Leverziekten, gepaard gaande met veranderingen in het bloedstollingsysteem, anamnistisch aanwijzingen voor bloedingneiging, zoals epistaxis en spontane hematomen, bekende levercirrose.
    E.5 End points
    E.5.1Primary end point(s)
    -Anatomical success (occlusion rate, evaluated using ultrasound scan)
    -Clinical success (CEAP, VCSS)
    -Peroperative pain (VAS-score)
    -Postoperative pain during two weeks post-treatment (VAS-score,used pain medication)
    -Anatomisch suces (occlusie percentage, geevalueerdmet duplex)
    -Klinisch succes (CEAP, VCSS)
    -Peroperatieve pijn (VAS-score)
    -Postoperatieve pijn gedurende twee weken na behandeling (VAS-score, gebruikte pijn medicatie)
    E.5.1.1Timepoint(s) of evaluation of this end point
    peroperative and first two weeks post-treatment
    peroperatief en de eerste twee weken na behandeling.
    E.5.2Secondary end point(s)
    -Postoperative complications
    -Disease specific and general health status (AVVQ, RAND-SF36)
    -Time to return to normal daily activities and work
    -Duration of the intervention using MOCA
    -Postoperatieve complicaties
    -ziekte specifieken en algemene gezondheidsstatus (AVVQ, RAND-SF36)
    -Tijd tot hertel dagelijkse bezigheiden en werk
    -Duur van de interventie
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients will be clinically evaluated and asked to fill out the Aberdeen Varicose Vein Questionnaire and the RAND 36 short form questionnaire pre-treatment, 4 weeks and 1 year after treatment.
    Patienten worden klinisch beoordeeld en gevraagd om de vragenlijsten in te vullen (AVVQ en RAND 36 SF) pre-operatief, 4 weken na behandeling en 1 jaar na 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 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 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 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 concerned4
    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
    laatste visite laatste studiepatient
    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 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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state90
    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
    geen
    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 Decision2018-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-20
    P. End of Trial
    P.End of Trial StatusOngoing
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