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    Summary
    EudraCT Number:2022-001452-42
    Sponsor's Protocol Code Number:HCB.2021.1309
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-05-30
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2022-001452-42
    A.3Full title of the trial
    EVALUATION OF PATIENTS WITH TOTAL CORONARY OCCLUSIONS WITH MULTIMODALITY IMAGE
    EVALUACIÓN DE PACIENTES CON OCLUSIONES CRÓNICAS TOTALES CORONARIAS CON IMAGEN MULTIMODAL.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EVALUATION OF PATIENTS WITH TOTAL CORONARY OCCLUSIONS WITH MULTIMODALITY IMAGE
    EVALUACIÓN DE PACIENTES CON OCLUSIONES CRÓNICAS TOTALES CORONARIAS CON IMAGEN MULTIMODAL.
    A.4.1Sponsor's protocol code numberHCB.2021.1309
    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 SponsorHOSPITAL CLINIC BARCELONA
    B.1.3.4CountrySpain
    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 supportHOSPITAL CLINIC BARCELONA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHOSPITAL CLINIC BARCELONA
    B.5.2Functional name of contact pointCardiovascular Institute
    B.5.3 Address:
    B.5.3.1Street AddressVILLARROEL 170
    B.5.3.2Town/ cityBARCELONA
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number34932275519
    B.5.6E-mailAREGUEIR@CLINIC.CAT
    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 Rapiscan
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare AS
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Solution for injection
    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 Eufilina
    D.2.1.1.2Name of the Marketing Authorisation holderzr pharma& GmbH
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Solution for injection
    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: 3
    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 Clariscan
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare Bio-Sciences, S.A.U
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Solution for injection
    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.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
    Coronary artery chronic total occlusion
    Oclusión crónica total coronaria
    E.1.1.1Medical condition in easily understood language
    Chronic total occlusion of an artery of the heart
    Obstrucción total de larga duración en arterias del corazón
    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 evaluate the concordance between CT Angio with stress and rest myocardial perfusion study and stress CMR for the detection of ischemia and viability in patients with Chronic Total Occlusion.
    Evaluar la concordancia entre el AngioTAC con estudio de perfusión miocárdica en estrés y reposo con la RMC de estrés para la detección de isquemia y viabilidad en pacientes con Oclusión Total Crónica.
    E.2.2Secondary objectives of the trial
    To assess the concordance between stress CMR without contrast using myocardial native T1 maps and conventional stress CMR with contrast for the detection of ischemia in patients with coronary CTO. To compare the modification of the arrhythmogenic substrate, both myocardial ischemia and the characterization of CMR Myocardial Scarring Before and After Percutaneous Revascularization of Coronary CTO.
    Evaluar la concordancia entre la RMC de estrés sin contraste mediante mapas de T1 nativo miocárdico y la RMC de estrés convencional con contraste para la detección de isquemia en pacientes con CTO coronaria.Comparar la modificación del sustrato arritmogénico, tanto la isquemia miocárdica como la caracterización de la cicatriz miocárdica mediante la RMC antes y después de la revascularización percutánea de una CTO coronaria.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Patients with successful revascularization of chronic occlusion with disease distal to the occlusion defined as angiographic stenosis ≥ 50%.
    Pacientes con revascularización exitosa de la oclusión crónica con enfermedad distal a la oclusión definida como estenosis angiográfica ≥ 50%.
    E.3Principal inclusion criteria
    • Chronic total occlusion in a native coronary artery
    • Age greater than or equal to 18 years
    • Vessel distal to the chronic occlusion of at least 2.5 mm in diameter
    • Ability to grant informed consent and willingness to carry out the follow-ups established by the protocol.
    • Oclusión crónica total en una arteria coronaria nativa
    • Edad mayor o igual a 18 años
    • Vaso distal a la oclusión crónica de al menos 2.5 mm de diámetro
    • Capacidad para otorgar un consentimiento informado y disposición para realizar los seguimientos establecidos por el protocolo.
    E.4Principal exclusion criteria
    • Multivessel disease with incomplete revascularization in the artery without total chronic occlusions.
    • Previous revascularization surgery in the artery with chronic total occlusion.
    • Acute myocardial infarction during the previous 3 months.
    • Coronary anatomy unfavorable for percutaneous revascularization of chronic total occlusion.
    • Coronary artery disease involving the common trunk or three vessels that is indicated for surgery according to the assessment of the multidisciplinary team.
    • Life expectancy less than 2 years.
    • Severe chronic renal failure (glomerular filtration rate ≤ 30 mL/min)
    • Contraindication for double antiplatelet therapy.
    • Pregnancy.
    • Severe valve disease with indication for surgery.
    • Enfermedad multivaso con revascularización incompleta en la arteria sin oclusiones crónicas totales.
    • Cirugía de revascularización previa en la arteria con oclusión crónica total.
    • Infarto agudo de miocardio durante los 3 meses previos.
    • Anatomía coronaria no favorable para revascularización percutánea de la oclusión crónica total.
    • Enfermedad coronaria que involucre el tronco común o tres vasos que tenga indicación para cirugía según la valoración del equipo multidisciplinar.
    • Expectativa de vida menor a 2 años.
    • Insuficiencia renal crónica grave (Filtrado glomerular ≤ 30 mL/min)
    • Contraindicación para doble antiagregación.
    • Embarazo.
    • Enfermedad valvular grave con indicación de cirugía.
    E.5 End points
    E.5.1Primary end point(s)
    Pending
    Pending
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pending
    Pending
    E.5.2Secondary end point(s)
    Pending
    Pending
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pending
    Pending
    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 No
    E.6.5Efficacy No
    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 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
    Last visit of follow-up of the last subject
    Última visita de seguimiento del último paciente incluido
    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 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: 43
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state78
    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)
    Pending
    Pending
    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 Decision2023-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-21
    P. End of Trial
    P.End of Trial StatusOngoing
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