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    Summary
    EudraCT Number:2015-002071-13
    Sponsor's Protocol Code Number:CIP0169
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-09-08
    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 ConcernedAustria - BASG
    A.2EudraCT number2015-002071-13
    A.3Full title of the trial
    Lower-Limb Adventitial Infusion of DexaMethasone via Bullfrog to Reduce Occurence of Restenosis after Percutaneous Transluminal Angioplasty Revascularization
    Infusion von Dexamethason in die Adventitia der Unterschenkelgefäße mittels Bullfrog um das Auftreten einer Re-Stenose nach PTA-Behandlung zu verringern
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    not applicable
    Verabreichung von Dexamethason in die äußere Blutgefäßwand von verengten Unterschenkelgefäßen mittels eines Verabreichungssystems (Bullfrog) um das Auftreten einer Wiederverengung nach Ballon-Behandlung der Gefäßverengung zu verringern.
    A.3.2Name or abbreviated title of the trial where available
    LIMBO-PTA
    LIMBO-PTA
    A.4.1Sponsor's protocol code numberCIP0169
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02479555
    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 SponsorMercator MedSystems, Inc.
    B.1.3.4CountryUnited States
    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 supportMercator MedSystems, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVascuScience GmbH
    B.5.2Functional name of contact pointClinical Research Organisation
    B.5.3 Address:
    B.5.3.1Street AddressPaul-List-Str. 11
    B.5.3.2Town/ cityLeipzig
    B.5.3.3Post code04103
    B.5.3.4CountryGermany
    B.5.4Telephone number0493412120830
    B.5.5Fax number04932224165269
    B.5.6E-mailinfo@vascuscience.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.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameDexamethasonedihydrogenphosphat-dinatrium
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDexamethasone
    D.3.9.3Other descriptive nameDEXAMETHASONE SODIUM PHOSPHATE
    D.3.9.4EV Substance CodeSUB01615MIG
    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
    Patients with clinical evidence of severe claudication or chronic critical limb ischemia with an angiographically significant lesion in the infrapopliteal crural vessels.
    Patienten mit klinischem Befund einer schweren Claudicatio intermittens oder chronischen kritischen Ischämie einhergehend mit einer angiographisch signifikanten Läsion in den Unterschenkelgefäßen.
    E.1.1.1Medical condition in easily understood language
    not applicable
    Patienten, welche unter der peripher arteriellen Verschlusskrankheit (Gefäßverengungen bzw. -verschlüsse) leiden.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10057525
    E.1.2Term Peripheral artery occlusion
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10072563
    E.1.2Term Peripheral artery stenosis
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10057518
    E.1.2Term Peripheral artery angioplasty
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and effectiveness of Bullfrog Micro-Infusion Device adventitial deposition of dexamethasone in reducing intimal hyperplasia, inflammatory markers and composite safety endpoints in patients with severe claudication or clinical evidence of chronic critical limb ischemia after angioplasty revascularization of one or more angiographically significant lesion(s) in the infrapopliteal crural vessels.
    Beurteilung der Sicherheit und Wirksamkeit des Dexamethason, welches mittels des Bullfrog® Mikro-Infusionskatheters adventitial verabreicht wurde. Dexamethason wird verabreicht zur Verminderung einer Intima Hyperplasie, von laboranalytischen Entzündungsmarkern und den kombinierten Sicherheitsendpunkten in Patienten mit klin. Befund einer schweren Claudicatio intermittens oder chronischen kritischen Ischämie nach Ballon-Revaskularisation von einer oder mehreren angiographisch signifikanten Läsion/en in den Unterschenkelgefäßen.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Screening Criteria
    o Age ≥18 years and <90 years
    o Patient has been informed of the nature of the study, agrees to participate and has signed an IRB/EC approved consent form
    o Female patients of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a highly effective method of birth control (see Section 12.2) for one month preceding and24 months following study treatment
    o Patient has documented severe claudication or chronic Critical Limb Ischemia (CLI) in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure with Rutherford Category 3, 4, 5 or 6
    o Life expectancy >1 year in the Investigator's opinion

    • Angiographic Criteria
    o Target vessel(s) diameter ≥2 mm and ≤8 mm
    o Single or multiple atherosclerotic lesion(s) ≥70% in at least one infrapopliteal crural target vessel including the tibioperoneal trunk that totals up to no greater than 30 cm in length (with no greater than 5 cm length of contiguous intervening normal artery), with possible extension into the popliteal artery distal to the center of the knee joint space (the P3 segment)
    o Successful revascularization of the TL with less than 30% residual stenosis, run-off down to the foot and direct in-line flow to any foot wound, if a wound is present at baseline
    • allgemeine Kriterien
    o Alter≥18 Jahre und < 90 Jahre
    o Patient wurde über das Wesen der Studie informiert, hat der Teilnahme der Studie zugestimmt, die Patienteninnformation verstanden und die -einwilligung unterschrieben
    o gebärfähige Patientinnen haben einen innerhalb von 7 Tagen vor der Prozedur durchgeführten negativen Schwangerschaftstest vorzuweisen und sind einverstanden, einen Monat vor der Prozedur bis 24 Monate nach dem Eingriff eine sehr zuverlässige Verhütungsmethoden (siehe Punkt 12.2) zu nutzen, um eine Schwangerschaft zu vermeiden
    o Patient hat nachweislich eine schwere Claudicatio intermittens oder chronische kritische Bein-Ischämie (CLI) mit einer Rutherford-Kategorie von 3, 4, 5 oder 6 am Studienbein vom distalen Segment der A. poplitea (P3) bis zum Sprunggelenk vor Studienprozedur
    o Lebenserwartung >1 Jahr nach Einschätzung durch den Prüfarzt

    • Angiographische Kriterien
    o Durchmesser des Zielgefäßes≥ 2 mm und ≤ 8 mm
    o Einzelne oder mehrere atherosklerotische Läsionen (≥70%) in mind. einem infrapoplitealen kruralen Zielgefäß, einschließlich des Trunkus Tibio-Peronealis mit einer Gesamtlänge von bis zu 30 cm (darin befindlich nicht mehr als 5 cm zusammenhängende gesunde Arterie), mit möglicher Verlängerung bis in das P3 Segment der A. poplitea
    o erfolgreiche Revaskularisation der TL mit weniger als 30 % Rest-Stenose, Blutfluss bis zum Fuß und direkter Blutfluss zu jeglichen Fusswunden, falls eine Wunde bereits zur Prozedur bestanden hat
    E.4Principal exclusion criteria
    Screening Criteria
    1. Patient unwilling or unlikely to comply with visit schedule
    2. Planned major index limb amputation
    3. Active foot infection; however, osteomyelitis in the toes or mild cellulitis around the perimeter of gangrene or small ulcers are not exclusions, but osteomyelitis of the metatarsal or more proximal region would be exclusionary
    4. Inability to receive study medications
    5. Estimated glomerular filtration rate (eGFR) less than 30 mL/min, except for patients with end stage renal disease on chronic hemodialysis
    6. Stage 3 (per SVS WIfI classification) or worse heel ulcers or heel ulcers that are determined to be primarily neuropathic in nature

    Angiographic/Procedural Criteria
    1. Hemodynamically significant inflow lesion (≥50% DS) or occlusion in the ipsilateral iliac, SFA, or popliteal arteries in which there is a failure to successfully treat and obtain a <30% residual stenosis
    2. Index lesion length is >30 cm as measured from proximal normal vessel to distal normal vessel
    3. Total length of lesions treated during the case (including target lesion, inflow lesions, and other non-index lesions) >50 cm
    4. Lesions revascularized during the index case but untreated by Bullfrog
    5. Use of alternative therapy, e.g. atherectomy, laser, or radiation therapy, as part of the index lesion treatment, or use of any drug eluting stents (DES) or drug-eluting balloon/drug-coated balloons (DEB/DCB) for treatment of any infra-inguinal lesions during the study procedure or during the initial six-month follow up period
    6. Previously implanted stent in the TL(s)
    7. Aneurysm in the target vessel
    8. Acute thrombus in the target limb
    9. Failure to cross the TL with a guide wire; however, subintimal wire crossing is allowed
    10. Heavy eccentric or concentric calcification at index lesion, which in the judgment of the investigator would prevent penetration of the Micro-Infusion Device needle through the vessel wall
    •Allgemeine Kriterien
    1. Patient ist mit den Nachuntersuchungen nicht einverstanden oder kann den Zeitplan dieser nicht einhalten
    2. große, geplante Amputationen am Studienbein
    3. bestehende Infektion am Fuß; Osteomyelitis in den Zehen oder milde Zellulitis im Umkreis bestehender Gangräne oder kleine Ulzerationen sind jedoch keine Ausschlussgründe, Unvermögen Studienmedikation zu nehmen
    4. Nicht in der Lage die Studienmedikation einzunehmen
    5. geschätzte glomeruläre Infiltrationsrate (eGFR) weniger als 30 ml/min, mit Ausnahme von Patienten im Endstadium einer Nierenerkrankung mit dauerhafter Hämodialyse
    6. Klasse 3 (per SVS Wlfl Klassifikation) oder schlechter als Klasse 3 oder Fersenulzeration, die primär neuropathischer Natur sind


    Angiographische/Prozedur-relevante Kriterien
    1. hämodynamisch signifikante Zuflussläsionen (≥50% Stenose) oder Verschluss in den ipsilateralen Beckenarterien, der AFS und Poplitealarterie konnten nicht erfolgreich behandelt werden und Nichterlangung einer Rest-Stenose von <30%
    2. Länge der Zielläsion ist >30 cm gemessen vom oberen gesunden bis zum unteren gesunden Gefäßabschnitt
    3. Gesamtlänge aller behandelten Läsionen während der Prozedur (einschl. Zielläsion, Zuflussläsion und andere Läsionen) ist >50 cm
    4. Läsionen wurden revaskularisiert, aber nicht mit dem Bullfrog® behandelt
    5. Einsatz von alternativen Behandlungsmethoden wie Atherektomie, Lasertherapie, Strahlentherapie, beschichteten Stents oder Ballons als Teil der Behandlung der Zielläsion oder der Einsatz medikament-freisetzender Stents (DES) oder medikament-freisetzender / medikament-beschichteten Ballons (DEB/DCB) für die Behandlung jeglicher Läsionen unterhalb der Leiste während der Studienprozedur oder während der 6 Monats-Nachsorgeperiode
    6. bereits implantierter Stent in der/den Zielläsion(en)
    7. Aneurysma im Zielgefäß
    8. akuter Thrombus im Studienbein
    9. Zielläsion kann nicht mit einem Führungsdraht durchquert werden
    10. schwerwiegende exzentrische und konzentrische Kalkablagerung in der Zielläsion, welche nach Auffassung des Prüfarztes die Durchdringung der Nadel des Mikro-Infusionskatheter in die Gefäßwand verhindern könnte
    E.5 End points
    E.5.1Primary end point(s)
    Safety: Freedom from a composite of death within 30 days from the index procedure, major adverse limb event (MALE), major unplanned amputation or clinically driven target lesion revascularization (TLR) within 6 months. Freedom from MALE within 6 months. Freedom from CD-TLR within 6 months. Effectiveness: Transverse-view vessel area loss percentage (TVAL%) of the target lesion at 6 months by quantitative vascular angiography (QVA) or prior to any clinically driven TLR of the target lesion before 6 months.
    Kombinierter Sicherheitsendpunkt: Nicht-Auftreten von Tod innerhalb von 30 Tagen nach Index Prozedur, besonders schwerwiegende Ereignisse das Studienbein betreffend (MALE), ungeplante große Amputationen oder klinisch-indiziert TLR innerhalb von 6 Monaten.
    Nicht-Auftreten eines MALE innerhalb von 6 Monaten. Nicht-Auftreten einer klinisch-indiziert TLR innerhalb von 6 Monaten.

    Wirksamkeit: prozentualer Lumenverlust in der Fläche des gesamten Gefäßabschnittes der Zielläsion (TVAL %) zum 6 Monats-Follow-up durch quantitative vaskuläre Angiographie (QVA) oder vor jeder klinisch-indizierter TLR vor dem 6 Monats-Follow-up.
    E.5.1.1Timepoint(s) of evaluation of this end point
    within 30 days after index procedure and 6 month
    innerhalb 30 Tagen nach Indexprozedur und 6 Monaten
    E.5.2Secondary end point(s)
    Safety: Freedom from a composite of death, unplanned amputation and clinically driven TLR, serious adverse events (SAE) and major adverse limb events (MALE) up to 12 months from the procedure for all subjects, and event-free survival to 12 months from the procedure for all subjects. Effectiveness: 6 month improvement % diameter stenosis (%DS) of the target lesion (TL) and the maximum late lumen loss for the lesion (LLL) will be assessed by Quantitative Vascular Angiography. 6 month improvement in intravascular ultrasound (IVUS) result within the TL (subgroup analysis). The following will be evaluated at 30 days, 6 and 12 months post-procedure: Amputation free survival, major and minor amputations, amputation level, number and size of foot wounds, reduction in number and size of baseline wounds, occurrence of new wounds, resolved CLI Death, clinically driven TLR, primary sustained clinical improvement, secondary sustained clinical improvement, SVS WIfI score [1], Quality of life assessment by EQ5D vs. baseline, walking capacity assessment vs. baseline, SAE/MALE, change in inflammatory biomarkers (hsCRP, MCP-1 and MMP-9) from baseline to 24 hours. Healthcare Economics: Number of hospital days throughout study, return visits and hospitalizations, time from index procedure to required revascularization and number of index-lesion-related readmissions within 24 months will be measured. Infusion Technical Success: The grade of distribution (A-F) around infusion sites will be used as a qualitative measure of technical success of adventitial delivery of the drug. Revascularization Success: Establishment of antegrade flow with residual stenosis <30% by angiogram.
    Kombinierter Sicherheitsendpunkt Nicht-Auftreten einer ungeplanten Amputation und klinisch-indizierter TLR, schwerwiegender unerwünschter Ereignisse (SAE) und MALE bis zu 12 Monaten nach Prozedur für alle Patienten

    Wirksamkeit: Verbesserung der Zielläsionstenose (%) und das maximale Late Lumen Loss (LLL) der Läsion nach 6 Monaten werden mittels quantitativer vaskulärer Angiographie bestimmt. Verbesserung der IVUS-Ergebnisse in der Zielläsion nach 6 Monaten (Untergruppenanalyse)
    Folgende Endpunkte werden nach 30 Tagen, 6 und 12 Monaten nach Prozedur evaluiert:
    Amputationsfreies Überleben, große und kleine Amputationen, Anzahl von Fußwunden, Reduktion der Anzahl von bestehenden Wunden, Auftreten von neuen Wunden, CLI beendet wegen Tod, klinisch-indizierte TLR, primär und sekundär anhaltende klinische Verbesserung,Bestimmung des SVS WIfI Wert ,Lebensqualität mittels EQ5D im Vergleich zum Studieneinschluss, Gehfähigkeit im Vergleich zum Studieneinschluss, SAEs/MALEs, Änderung l der Entzündungsmarker (hsCRP, MCP-1 und MMP-9) nach 24h im Vergleich zum Studieneinschluss

    Gesundheitsökonomie: Anzahl der Krankenhaustage während der Studie, Wiedervorstellung und Krankenhausaufenthalte, Zeit von der Indexprozedur bis zu einer notwendigen Revaskularisation und Anzahl der Indexläsions-bezogenenen Wiederaufnahmen innerhalb von 12 Monaten

    Technischer Infusionserfolg: Grad der Verteilung (A-F) um die Infusionsstellen wird genutzt als qualitatives Maß des technischen Erfolges der Abgabe des Prüfpräparates (Dexamethason oder Placebo) in die Adventitia.

    Prozedurerfolg: Erlangung des antegraden Blutflusses mit einer Reststenose von <30% , angiographisch bestätigt.
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days, 6 and 12 months after index-procedure
    30 Tage, 6 und 12 Monate nach Indexprozedur
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) Yes
    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 Yes
    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 Yes
    E.8.2.3Other No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Germany
    Switzerland
    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

    If there is any statistically observed negative safety effects seen in the treatment group as compared to the control group, the CEC may choose to suspend the trial for further investigation or to completely terminate the trial on the grounds of safety.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 120
    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)
    Each subject that is treated under this clinical investigation will experience a FU treatment according to the established standard of medical care after study exit. It is the responsibility of each participating site to take care that all enrolled subjects will be followed up after study exit by a medical specialist or general practitioner. Each PI shall confirm that the medical care of each subject after study exit will be ensured.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-10-23
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