Clinical Trials Register

Summary
EudraCT Number:	2016-004501-14
Sponsor's Protocol Code Number:	EDC-3135
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2016-11-16
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

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2016-004501-14

A.3

Full title of the trial

COOL-AMI EU PIVOTAL TRIAL: A MULTICENTER, PROSPECTIVE, RANDOMIZED- CONTROLLED TRIAL TO ASSESS THE SAFETY AND EFFECTIVENESS OF COOLING AS AN ADJUNCTIVE THERAPY TO PERCUTANEOUS INTERVENTION INP A TIENTS WITH ACUTE MYOCARDIAL INFARCTION

COOL-AMI EU PIVOTAL-STUDIE: EINE MULTIZENTRISCHE, PROSPEKTIVE, RANDOMISIERTE, KONTROLLIERTE STUDIE ZUR BEURTEILUNG DER SICHERHEIT UND WIRKSAMKEIT VON KÜHLUNG ALS BEGLEITTHERAPIE ZUR PERKUTANEN INTERVENTION BEI PATIENTEN MIT AKUTEM MYOKARDINFARKT

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A.3.2

Name or abbreviated title of the trial where available

COOL AMI EU PIVOTAL TRIAL

COOL AMI EU PIVOTAL-STUDIE

A.4.1

Sponsor's protocol code number

EDC-3135

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	ZOLL, Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	ZOLL, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ZOLL Medical
B.5.2	Functional name of contact point	Clinical Affairs
B.5.3	Address:
B.5.3.1	Street Address	Emil-Hoffmann-Strasse 13
B.5.3.2	Town/ city	Köln
B.5.3.3	Post code	50996
B.5.3.4	Country	Germany
B.5.4	Telephone number	+492236878729

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Anxut 5 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Eisai GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Buspirone Hydrochloride
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Anxut 5 mg
D.3.9.1	CAS number	33386-08-2
D.3.9.3	Other descriptive name	BUSPIRONE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB00906MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Pethidin-hameln 50 mg/ml
D.2.1.1.2	Name of the Marketing Authorisation holder	hameln pharmaceuticals GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Pethidin-hameln 50 mg/ml
D.3.2	Product code	Pethidine Hydrochloride
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pethidin-hameln 50 mg/ml
D.3.9.1	CAS number	50-13-5
D.3.9.3	Other descriptive name	PETHIDINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB03726MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Anxut 10 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Eisai GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Buspirone Hydrochloride
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Anxut 10 mg
D.3.9.1	CAS number	33386-08-2
D.3.9.3	Other descriptive name	BUSPIRONE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB00906MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another 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.1.1

Medical condition(s) being investigated

Acute Myocardial Infarction

Akuter Myokardinfarkt

E.1.1.1

Medical condition in easily understood language

Myocardial infarction

Herzinfarkt

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10000891
E.1.2	Term	Acute myocardial infarction
E.1.2	System Organ Class	10007541 - Cardiac disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The objective of this trial is to evaluate the safety and effectiveness of therapeutic hypothermia, using the ZOLL Proteus IVTM System, as an adjunctive therapy for patients presenting with acute anterior myocardial infarction (AMI) and undergoing percutaneous coronary intervention (PCI).

Das Ziel dieser Studie ist es, die Beurteilung der Sicherheit und Wirksamkeit der therapeutischen Hypothermie unter Verwendung des ZOLL Proteus IVTM‐Systems als eine Begleittherapie für Patienten mit akutem anterioren Myokardinfarkt (AMI) und Intervention mit PCI zu bewerten.

E.2.2

Secondary objectives of the trial

Not applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

All Inclusion Criteria must be answered YES for subject to satisfy Inclusion Criteria:
1. The patient is ≥ 18 years of age
2. The patient must have symptoms consistent with AMI (i.e. chest
pain, arm pain, etc.) and unresponsive to nitroglycerin, with symptoms beginning greater than 30 minutes but less than 6 hours prior to presentation at hospital.
3. Qualifying Infarct location: Evidence of Acute Anterior MI only with ST-segment elevation of ≥ 0,2 mV in two or more anterior contiguous precordial leads.
4. The patient is eligible for PCI.
5. The patient is willing to provide written informed consent to
participate in this clinical trial.

Alle Einschlusskriterien müssen mit JA beantwortet, damit ein Patient für den Studieneinschluss in Frage kommt.
1. Alter ≥ 18 Jahre.
2. Symptome, die auf einen akuten Myokardinfarkt (AMI) schließen
lassen (d. h. Schmerzen im Thorax, Schmerzen im Arm usw.) und nicht reagierend auf Nitroglyzerin, und Einsetzen der Symptomatik mehr als 30 Minuten, aber weniger als 6 Stunden vor der Hospitalisierung.
3. Lokalisierung des Infarkts: Vorderwand‐MI mit einer ST‐Strecken‐ Hebung ≥ 0,2 mV in zwei oder mehr benachbarten präkordialen Ableitungen.
4. Der Patient kommt für eine PCI in Frage.
5. Der Patient ist einverstanden, eine schriftliche Einwilligungserklärung
zur Teilnahme an dieser klinischen Studie abzugeben.

E.4

Principal exclusion criteria

All Exclusion Criteria must be answered NO for subject to satisfy Exclusion Criteria:
1. The patient has had a previous Myocardial Infarction.
2. The patient is experiencing cardiogenic shock (systolic blood
pressure [SBP] <80 mmHg and non-responsive to fluids, or SBP <100 mmHg with vasopressors, or requirement for an intra-aortic balloon pump [IABP]).
3. The patient is presenting with resuscitated cardiac arrest, atrial fibrillation, or Killip risk stratification class II through IV.
4. The patient has an aortic dissection or requires an immediate surgical or procedural intervention other than PCI.
5. The patient has known history of Congestive Heart Failure (CHF), hepatic failure, end-stage kidney disease or severe renal failure (clearance< 30ml/min/l.73m2) .
6. The patient is febrile (temperature> 37.5 °C) or has experienced an infection with fever in the last 5 days.
7. The patient has a known previous CABG.
8. The patient has a known recent stroke within 90 days of admission.
9. Cardio-pulmonary decompensation that has occurred en route to
the hospital or, in the opinion ofthe physician, that is imminent or
likely to occur following presentation to the clinical site.
10. Contraindications to hypothermia, such as patients with known
hematologic dyscrasias which affect thrombosis (e.g., cryoglobulinemia, sickle cell disease, serum cold agglutinins) or vasospastic disorders (such as Raynaud's or thromboangitis obliterans).The patient has a known hypersensitivity or contraindication to aspirin, heparin, or sensitivity to contrast media, which cannot be adequately pre-medicated.
11. Any contraindication to cardiac MRI, or any implant in the upper body which may cause artifacts on cardiac MRI imaging.
12. The patient has a known hypersensitivity or contraindication to aspirin, heparin, or sensitivity to contrast media, which cannot be adequately pre-medicated.
13. The patient has a known history ofbleeding diathesis, coagulopathy, cryoglobulinemia, sickle cell anemia, or will refuse blood transfusions.
14. The patient has a height of <1.5 meters (4 feet 11 inches).
15. The patient has a known hypersensitivity or contraindication to
buspirone hydrochloride or Pethidine (Meperidine) and/or has been treated with a monoamine oxidase inhibitor in the past 14 days.
16. Patient has a known history of severe hepatic or renal impairment, untreated hypothyroidism, Addison's disease, benign prostatic hypertrophy, or urethral stricture that in the opinion ofthe physician would be incompatible with Pethidine administration.
17. The patient has an Inferior Vena Cava filter in place (IVC).
18.The patient has a pre-MI life expectancy of <1 year due to underlying medical conditions or pre-existing co-morbidities.
19. The patient has a known, unresolved history of drug use or alcohol dependency, or lacks the ability to comprehend or follow instructions.
20. The patient is currently enrolled in another investigational drug or device trial.
21. The patient is apprehensive about or unwilling to undergo the required MRI imaging at follow-up, has a documented or suspected diagnosis of claustrophobia, or has Gadolinium allergy, or is in permanent Atrial Fibrillation.
22. The patient has received thrombolytic therapy en route to the hospital.
23. The patient shows clinical evidence of spontaneous reperfusion as observed symptomatically and/ or from ECG findings (partial or complete ST resolution in ECG prior to informed consent and randomization).
24. The patient is a vulnerable subject, for instance, a person in detention (i.e., prisoner or ward ofthe state).
25. The patient is a female who is known to be pregnant.

Alle Ausschlußkriterien müssen mit NEIN beantwortet werden.
1. Der Patient hatte bereits früher einen Myokardinfarkt.
2. Akuter kardiogener Schock (systolischer Blutdruck [RRsyst] < 80 mmHg
und kein Ansprechen auf eine intravenöse Volumensubstitution oder RRsyst < 100 mmHg bei Anwendung von blutdrucksteigernden Mitteln oder Notwendigkeit der Durchführung eines intraaortalen Ballonverfahrens [IABP]).
3. Reanimationspflichtiger Herzstillstand, Vorhofflimmern oder Killip‐ Klasse zur Risikostratifizierung II–IV bei der Hospitalisierung.
4. Aortendissektion oder bestehende Notwendigkeit für einen notfallmäßigen chirurgischen Eingriff oder eine anderweitige Intervention außer der PCI.
5. Anamnestisch bekannte(s) dekompensierte Herzinsuffizienz, Leberinsuffizienz, terminale Niereninsuffizienz oder schweres Nierenversagen (Clearance < 30 ml/min/1,73 m2).
6. Fieber (Körpertemperatur > 37,5 °C) oder anamnestisch bekannte febrile Infektion in den vorangegangenen 5 Tagen.
7. Anamnestisch bekannter Koronararterien‐Bypass.
8. Anamnestisch bekannter Schlaganfall in den 90 Tagen vor der
Hospitalisierung.
9. Auftreten einer kardiopulmonalen Dekompensation auf dem Weg in
die Klinik oder nach Ansicht des Arztes unmittelbar bevorstehende kardiopulmonale Dekompensation oder nach Ansicht des Arztes große Wahrscheinlichkeit für das Auftreten einer kardiopulmonalen Dekompensation im Verlauf des Klinikaufenthalts.
10. Bestehen von Kontraindikationen zur therapeutischen Hypothermie, z. B. bekanntes Vorliegen einer hämatologischen Dyskrasie, die mit einer Störung der Blutgerinnung einhergeht (z. B. Kryoglobulinämie, Sichelzellenanämie, Vorliegen von Kälteagglutininen im Serum), oder vasospastische Störung (z. B. Raynaud‐Syndrom oder Endangiitis obliterans).
11. Jegliche Kontraindikation für ein kardiales MR (cMR) oder Implantate, welche Artefakte verursachen können.
12. Bekannte, nicht medikamentös vorbehandelbare Überempfindlichkeit oder Kontraindikation in Bezug auf ASS, Heparin oder Kontrastmittel.
13. Anamnestisch bekannte hämorrhagische Diathese, Koagulopathie, Kryoglobulinämie oder Sichelzellenanämie oder Verweigerung von Bluttransfusionen.
14. Körpergröße < 150 cm.
15. Bekannte Überempfindlichkeit oder Kontraindikation gegenüber
Buspironhydrochlorid oder Pethidin und/oder Behandlung mit einem
Monoaminoxidase‐Hemmer in den vorangegangenen 14 Tagen.
16. Anamnestisch bekannte schwere Leber‐ oder Nierenfunktionsstörung,
unbehandelte Hypothyreose, Morbus Addison, benigne Prostata‐ hypertrophie oder Harnröhrenstriktur, die nach Ansicht des Arztes nicht mit einer Pethidin‐Gabe vereinbar wäre.
17. Implantierter Vena‐cava‐Filter (IVC).
18. Bereits vor dem MI bestehende Lebenserwartung < 1 Jahr aufgrund
einer Vorerkrankung oder Komorbidität.
19. Anamnestisch bekannte und noch bestehende Abhängigkeit von
Drogen, Arzneimitteln oder Alkohol, oder fehlende Fähigkeit,
Anweisungen zu verstehen bzw. zu befolgen.
20. Aktuelle Teilnahme an einer anderen Studie, in der ein noch nicht
zugelassenes Arzneimittel oder ein noch nicht zugelassenes
Medizinprodukt geprüft wird.
21. Furcht vor der Durchführung oder fehlende Bereitschaft zur
Durchführung der im Rahmen der Nachbeobachtung erforderlichen MRT, oder anamnestisch bekannte Klaustrophobie bzw. entsprechender Verdacht, oder Gadolinium‐Überempfindlichkeit, oder permanentes Vorhofflimmern.
22. Anwendung eines Thrombolytikums auf dem Weg in die Klinik.
23. Bei der Aufnahme vorliegende klinische Hinweise auf eine spontane
Reperfusion, z. B. anhand der Symptomatik und/oder anhand der EKG‐ Befunde (partielle oder vollständige ST‐Rückbildung im EKG vor der Randomisierung).
24. Schutzbedürftigkeit des Patienten, z. B. Gefängnisinsassen oder unter Vormundschaft stehende Personen.
25. Bekannte Schwangerschaft.

E.5 End points

E.5.1

Primary end point(s)

Relative reduction of 20% in mean anterior myocardial infarct size as determined by Cardiac Magnetic Resonance (cMR) imaging at 4-6 days post infarct in the Test Arm (cooling+ PCI) relative to the Control Arm (PCI only).

Relative Reduktion um 20% der anterioren Myokardinfarktgröße, bestimmt durch cMR‐Bildgebung bei 4‐6 Tagen nach dem Infarkt in der Testgruppe (Kühlung+PCI) gegenüber der Kontrollgruppe (nur PCI).

E.5.1.1

Timepoint(s) of evaluation of this end point

During and at the end of the observation period (4-6 days post infarct).

E.5.2

Secondary end point(s)

Per-patient rate of composite endpoint of Major Adverse Cardiac Events (MACE) in randomized subjects, defined as Cardiac Death, all Myocardial Infarction and Clinically-Indicated Target Lesion Revascularization at 30 day follow-up period.

Das Auftreten je Patient der Kombination unerwünschter schwerwiegender kardialer Ereignisse (Major Adverse Cardiac Events (MACE)) bei randomisierten Patienten definiert als Herztod (CD), alle Myokardinfarkte (all MI) und klinisch‐angezeigte Revaskularisierungen der Zielläsion (CI‐TLR) bei der Nachbeobachtung nach 30 Tagen; Nichtunterlegenheit gegenüber der Kontrollgruppe.

E.5.2.1

Timepoint(s) of evaluation of this end point

30 day follow-up

Nachbeobachtung nach 30 Tagen

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

randomized, controlled

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

conventional treatment with PCI

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Austria

Bosnia and Herzegovina

Bulgaria

Croatia

Czech Republic

Denmark

Estonia

France

Germany

Greece

Hungary

Italy

Latvia

Macedonia, the former Yugoslav Republic of

Poland

Portugal

Serbia

Slovakia

Slovenia

Spain

Sweden

Switzerland

United Kingdom

E.8.7

Trial 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

After 1 year follow-up

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

368

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

150

F.4.2

For a multinational trial

F.4.2.1

In the EEA

420

F.4.2.2

In the whole clinical trial

468

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)

Patients receive the standard care provided by the investigator or research center, or the standard care determined at the center at the discretion of the physician and investigator.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-01-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

P. End of Trial
P.	End of Trial Status	Ongoing

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IMP with orphan designation in the indication
Orphan Designation Number:
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