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The SELUTION DeNovo Study

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SELUTION SLR
DES
Sponsored by
M.A. Med Alliance S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Drug Eluting Balloon, Coronary, De Novo coronary lesions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Subjects must meet all the following criteria to participate in the trial:

  • Subject age is ≥ 18 years (or 21 according to countries legal age)
  • Female subjects of childbearing potential have a negative pregnancy test ≤7 days before the procedure or are using a contraceptive device or drug.
  • Documented angina and/or positive functional testing or unstable angina or stabilized NSTEMI presentation.
  • Life expectancy >1 year
  • Written informed consent by the subject or her/his legally authorized representative for participation in the study
  • One or more native target vessel (LAD, LCX or RCA) is considered to require intervention and is suitable for treatment of all lesions with either DEB + provisional stenting or with DES and is identified as such.
  • The number of trial target lesions is not limited, but in the operator's opinion, if the subject is randomized to the DEB arm, the likelihood of the subject requiring provisional stenting of any of the identified trial target lesions is < 30%, and if randomized to the systematic DES arm, all lesions are considered amenable to stenting.
  • All target lesions: diameter between 2.0 and 5 mm, and diameter stenosis >50% and <100% with distal flow at least TIMI 2

Exclusion Criteria:

Age < 18 years (or 21 according to countries legal age)

  • Subject is pregnant or breast-feeding
  • Definite or suspected clinically active covid-19 infection
  • Subject is under judicial protection, tutorship or curatorship (for France only)
  • Subject is unable to fully comply with the study protocol
  • Contraindications to dual antiplatelet therapy, sirolimus or its analogues
  • Presentation with STEMI
  • Presentation with NSTEMI and ongoing chest pain or hemodynamic instability
  • Presentation with Killip III (pulmonary oedema) or IV (cardiogenic shock)
  • Chronic NYHA class III or IV heart failure prior to index PCI
  • Known LVEF < 30% prior to index PCI
  • Previous PCI of a trial target vessel at any time
  • Previous PCI of a non-trial target vessel within 30 days
  • Trial target lesion located in the left main or any arterial or venous graft
  • Trial target lesion is chronic total occlusion (CTO) or in-stent restenosis (ISR)
  • Subject considered not able to tolerate at least 30 seconds of coronary occlusion for each trial target lesion
  • RVD of trial target lesion > 5mm
  • Planned major surgery within one month following the procedure
  • Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up

Sites / Locations

  • Academic Teaching Hospital FeldkirchRecruiting
  • University Heart Center GrazRecruiting
  • University Hospital BrnoRecruiting
  • University Hospital OstravaRecruiting
  • SIUN sote Hospital and Healthcare centerRecruiting
  • CH La RochelleRecruiting
  • Hôpital Jaques CartierRecruiting
  • CHU de NîmesRecruiting
  • Hôpital Européen Georges PompidouRecruiting
  • Centre Hospitalier de PauRecruiting
  • Clinique Saint HilaireRecruiting
  • Universitätsklinik AugsburgRecruiting
  • BG Klinikum Unfallkrankenhaus BerlinRecruiting
  • Charite Campus Virchow KlinikumRecruiting
  • RKH Kliniken Bruchsal Fürst Stirum KlinikRecruiting
  • Elisabeth-KrankenhausRecruiting
  • Asklepios Kliniken GmbH & Co.Recruiting
  • University Medical Center Hamburg EppendorfRecruiting
  • University KoelnRecruiting
  • MEDICLIN Herzzentrum LahrRecruiting
  • Johannes Wesling Klinikum MindenRecruiting
  • Universitätsklinikum TübingenRecruiting
  • Herzklinikum UlmRecruiting
  • Ospedale Civile Santi Antonio e Biagio e Cesare ArrigoRecruiting
  • Clinica MediterraneaRecruiting
  • Ospedale Santa Croce di MoncalieriRecruiting
  • Ospedale Sant'andreaRecruiting
  • Szpital Kliniczny Przemienienia Pańskiego UMRecruiting
  • Kliniczny Szpital Wojewódzki Nr. 2 w RzeszowieRecruiting
  • Szpital Ministerstwa Spraw WewnetrznychRecruiting
  • University Hospital of BernRecruiting
  • University Hospital Geneva (HUG)Recruiting
  • University ZurichRecruiting
  • University Hospitals of North Midlands, Royal Stoke University HospitalRecruiting
  • The Royal Bournemouth and Christchurch HospitalsRecruiting
  • Royal Sussex County HospitalRecruiting
  • University Hospitals BristolRecruiting
  • Royal Infirmary of EdinburghRecruiting
  • Golden Jubilee National HospitalRecruiting
  • Glenfield HospitalRecruiting
  • Manchester University NHS Foundation TrustRecruiting
  • Norfolk and Norwich University HospitalsRecruiting
  • Trent Cardiac Centre, Nottingham City HospitalRecruiting
  • Royal Berkshire HospitalRecruiting
  • Northern General, SheffieldRecruiting
  • Worcestershire Royal HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

SELUTION SLR DEB

DES

Arm Description

Device: SELUTION SLR DEB. For patients randomized to the DEB strategy, all target lesions should be treated with DEB after appropriate lesion preparation, but provisional DES implantation is acceptable if the angiographic result is considered insufficient either after lesion preparation of after DEB treatment (poor flow, dissection type C or higher, residual stenosis > 30%). For bifurcation lesions, when both main and side- branch are considered to require treatment, a DEB should be used for both.

Device: Drug Eluting Stent. For patients randomized to the DES strategy, all target lesions should be treated with DES, but use of a SELUTION SLR™ DEB or any other device is acceptable if a DES cannot be delivered to the target lesion. For bifurcation lesions, if the side-branch requires treatment it should be treated with another DES or with POBA, at the discretion of the operator, but not with a DEB.

Outcomes

Primary Outcome Measures

TVF
- TVF (cardiac death, target-vessel related myocardial infarction (MI) or clinically driven target vessel revascularization (cd-TVR) at 1 year
TVF
- TVF (cardiac death, target-vessel related myocardial infarction (MI) or clinically driven target vessel revascularization (cd-TVR)) at 5 years

Secondary Outcome Measures

Death or any MI
Cardiac death, non-cardiac death, or any Myocardial Infarction
CD-TVR
Clinically driven - Target Vessel Revascularization
TVF
Target Vessel Failure
Any revascularization
Target lesion revascularization (TLR) - any and clinically driven Target vessel revascularization (TVR) - any and clinically driven A new lesion revascularization in a target vessel Non-Target vessel revascularization
Myocardial Infarction (MI)
Peri-procedural MI Target-vessel MI Non-target-vessel MI MI type (1 to 5) according to the 4th universal definition
Composite of cardiac death or target vessel MI
Composite of cardiac death or target vessel Myocardial Infarction
All-cause mortality
Cardiac mortality Non-cardiac mortality
Patient-oriented ARC-2 composite endpoint
All-cause mortality Any stroke Any MI (includes non-target vessel territory) Any revascularization
Site-reported stroke
Site-reported stroke
Site-reported BARC 3-5 Bleeding
Site-reported BARC (Bleeding Academic Research Consortium ) 3-5 Bleeding
Cost-effectiveness of DEB vs. DES after 12 months in selected countries
Total costs of materials used during treatment
Cost-effectiveness of DEB vs. DES after 12 months in selected countries
Time of procedure. Total minutes from patient introducer introduction until removal
Cost-effectiveness of DEB vs. DES after 12 months in selected countries
Total hospitalization days per procedure.
Net clinical benefit, a combination of freedom from TVF and/or BARC 3-5 bleeding
Net clinical benefit, a combination of freedom from (Target Vessel Failure) TVF and/or BARC 3-5 bleeding
Device success
Device success defined as achievement of a final residual diameter stenosis of < 30% (site-reported), using the assigned device only
Lesion success
Lesion success defined as achievement of < 30% residual stenosis (site-reported), using any PCI method
Procedure success
Procedure success defined as achievement of a final diameter stenosis of < 30% (site-reported) using any PCI method, without the occurrence of death, MI, or repeat target vessel revascularization during hospital stay

Full Information

First Posted
March 23, 2021
Last Updated
October 18, 2023
Sponsor
M.A. Med Alliance S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT04859985
Brief Title
The SELUTION DeNovo Study
Official Title
SELUTION DeNovo - A Prospective Randomized, Multi-center, International, Single-blind, Clinical Trial Compared the Selution DEB Strategy Versus DES Strategy.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
April 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.A. Med Alliance S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A Prospective Randomized, Multi-center, International, Single-blind, Clinical trial compared the Selution DEB strategy versus DES strategy.
Detailed Description
Randomized, multi-center, international, single-blind, clinical trial. Patients meeting eligibility criteria will be randomized 1:1 to treatment of all lesions of the identified trial target vessel(s) with either the SELUTION SLR DEB or DES. Patients randomized to the SELUTION SLR DEB arm will receive lesion preparation according to the 3rd DCB consensus (optimal balloon angioplasty with adjunct treatment using high-pressure balloon, shockwave, rotational atherectomy or cutting or scoring balloon at the discretion of the operator when necessary to maximize lumen diameter). Patients with lesions that are then best treated by provisional stenting (flow-limiting dissection, residual stenosis > 30% or FFR < 0.8) before or after use of DEB will receive a DES but remain in the SELUTION DEB group (intention to treat analysis). Patients randomized to the DES arm will receive treatment using any CE-marked DES, as per standard institutional practice. Patients with failure to deliver DES will be first treated by provisional DEB using the SELUTION DEB, and failing that, with any other device deemed appropriate. Staged procedures are allowed if they are planned less than 45 days after the index procedure and are done according to the initial treatment allocation for all trial target vessels (DEB if DEB arm, DES if DES arm). The study will test: for non-inferiority of a DEB plus provisional DES treatment strategy versus a systematic DES strategy with respect to the primary endpoint of TVF at 12 months. for long-term superiority at 5 years of the DEB strategy with TVF as an endpoint All Patients will be followed for clinical outcomes at 30 days, 6 months, 1 2, 3, 4 and 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Drug Eluting Balloon, Coronary, De Novo coronary lesions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3326 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SELUTION SLR DEB
Arm Type
Experimental
Arm Description
Device: SELUTION SLR DEB. For patients randomized to the DEB strategy, all target lesions should be treated with DEB after appropriate lesion preparation, but provisional DES implantation is acceptable if the angiographic result is considered insufficient either after lesion preparation of after DEB treatment (poor flow, dissection type C or higher, residual stenosis > 30%). For bifurcation lesions, when both main and side- branch are considered to require treatment, a DEB should be used for both.
Arm Title
DES
Arm Type
Other
Arm Description
Device: Drug Eluting Stent. For patients randomized to the DES strategy, all target lesions should be treated with DES, but use of a SELUTION SLR™ DEB or any other device is acceptable if a DES cannot be delivered to the target lesion. For bifurcation lesions, if the side-branch requires treatment it should be treated with another DES or with POBA, at the discretion of the operator, but not with a DEB.
Intervention Type
Device
Intervention Name(s)
SELUTION SLR
Intervention Description
Patients randomized to the SELUTION SLR™ DEB arm will receive lesion preparation according to the 3rd DCB consensus (optimal balloon angioplasty with adjunct treatment using high-pressure balloon, shockwave, rotational atherectomy or cutting or scoring balloon at the discretion of the operator when necessary to maximize lumen diameter). Patients with lesions that are then best treated by provisional stenting (flow-limiting dissection, residual stenosis > 30% or FFR < 0.8) before or after use of DEB will receive a DES but remain in the SELUTION SLR™ DEB group (intention to treat analysis).
Intervention Type
Device
Intervention Name(s)
DES
Intervention Description
For patients randomized to the DES strategy, all target lesions should be treated with DES, but use of a SELUTION SLR™ DEB or any other device is acceptable if a DES cannot be delivered to the target lesion. For bifurcation lesions, if the side-branch requires treatment it should be treated with another DES or with POBA, at the discretion of the operator, but not with a DEB.
Primary Outcome Measure Information:
Title
TVF
Description
- TVF (cardiac death, target-vessel related myocardial infarction (MI) or clinically driven target vessel revascularization (cd-TVR) at 1 year
Time Frame
1 year after treatment
Title
TVF
Description
- TVF (cardiac death, target-vessel related myocardial infarction (MI) or clinically driven target vessel revascularization (cd-TVR)) at 5 years
Time Frame
5 years after treatment
Secondary Outcome Measure Information:
Title
Death or any MI
Description
Cardiac death, non-cardiac death, or any Myocardial Infarction
Time Frame
30 days after treatment
Title
CD-TVR
Description
Clinically driven - Target Vessel Revascularization
Time Frame
30 days after treatment
Title
TVF
Description
Target Vessel Failure
Time Frame
2, 3, 4, 5 years after treatment
Title
Any revascularization
Description
Target lesion revascularization (TLR) - any and clinically driven Target vessel revascularization (TVR) - any and clinically driven A new lesion revascularization in a target vessel Non-Target vessel revascularization
Time Frame
30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Title
Myocardial Infarction (MI)
Description
Peri-procedural MI Target-vessel MI Non-target-vessel MI MI type (1 to 5) according to the 4th universal definition
Time Frame
30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Title
Composite of cardiac death or target vessel MI
Description
Composite of cardiac death or target vessel Myocardial Infarction
Time Frame
30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Title
All-cause mortality
Description
Cardiac mortality Non-cardiac mortality
Time Frame
30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Title
Patient-oriented ARC-2 composite endpoint
Description
All-cause mortality Any stroke Any MI (includes non-target vessel territory) Any revascularization
Time Frame
30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Title
Site-reported stroke
Description
Site-reported stroke
Time Frame
30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Title
Site-reported BARC 3-5 Bleeding
Description
Site-reported BARC (Bleeding Academic Research Consortium ) 3-5 Bleeding
Time Frame
30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Title
Cost-effectiveness of DEB vs. DES after 12 months in selected countries
Description
Total costs of materials used during treatment
Time Frame
1, 2, 3, 4 and 5 years after treatment
Title
Cost-effectiveness of DEB vs. DES after 12 months in selected countries
Description
Time of procedure. Total minutes from patient introducer introduction until removal
Time Frame
1, 2, 3, 4 and 5 years after treatment
Title
Cost-effectiveness of DEB vs. DES after 12 months in selected countries
Description
Total hospitalization days per procedure.
Time Frame
1, 2, 3, 4 and 5 years after treatment
Title
Net clinical benefit, a combination of freedom from TVF and/or BARC 3-5 bleeding
Description
Net clinical benefit, a combination of freedom from (Target Vessel Failure) TVF and/or BARC 3-5 bleeding
Time Frame
30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Title
Device success
Description
Device success defined as achievement of a final residual diameter stenosis of < 30% (site-reported), using the assigned device only
Time Frame
30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Title
Lesion success
Description
Lesion success defined as achievement of < 30% residual stenosis (site-reported), using any PCI method
Time Frame
30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Title
Procedure success
Description
Procedure success defined as achievement of a final diameter stenosis of < 30% (site-reported) using any PCI method, without the occurrence of death, MI, or repeat target vessel revascularization during hospital stay
Time Frame
30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Subjects must meet all the following criteria to participate in the trial: Subject age is ≥ 18 years (or 21 according to countries legal age) Female subjects of childbearing potential have a negative pregnancy test ≤7 days before the procedure or are using a contraceptive device or drug. Documented angina and/or positive functional testing or unstable angina or stabilized NSTEMI presentation. Life expectancy >1 year Written informed consent by the subject or her/his legally authorized representative for participation in the study One or more native target vessel (LAD, LCX or RCA) is considered to require intervention and is suitable for treatment of all lesions with either DEB + provisional stenting or with DES and is identified as such. The number of trial target lesions is not limited, but in the operator's opinion, if the subject is randomized to the DEB arm, the likelihood of the subject requiring provisional stenting of any of the identified trial target lesions is < 30%, and if randomized to the systematic DES arm, all lesions are considered amenable to stenting. All target lesions: diameter between 2.0 and 5 mm, and diameter stenosis >50% and <100% with distal flow at least TIMI 2 Exclusion Criteria: Age < 18 years (or 21 according to countries legal age) Subject is pregnant or breast-feeding Definite or suspected clinically active covid-19 infection Subject is under judicial protection, tutorship or curatorship (for France only) Subject is unable to fully comply with the study protocol Contraindications to dual antiplatelet therapy, sirolimus or its analogues Presentation with STEMI Presentation with NSTEMI and ongoing chest pain or hemodynamic instability Presentation with Killip III (pulmonary oedema) or IV (cardiogenic shock) Chronic NYHA class III or IV heart failure prior to index PCI Known LVEF < 30% prior to index PCI Previous PCI of a trial target vessel at any time Previous PCI of a non-trial target vessel within 30 days Trial target lesion located in the left main or any arterial or venous graft Trial target lesion is chronic total occlusion (CTO) or in-stent restenosis (ISR) Subject considered not able to tolerate at least 30 seconds of coronary occlusion for each trial target lesion RVD of trial target lesion > 5mm Planned major surgery within one month following the procedure Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Team SelutionDenovo
Phone
00 41 22 363 7890
Email
selutiondenovo@medalliance.com
Facility Information:
Facility Name
Academic Teaching Hospital Feldkirch
City
Feldkirch
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Frick
Facility Name
University Heart Center Graz
City
Graz
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabor Toth, Dr.
Facility Name
University Hospital Brno
City
Brno
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Poloczek, MUDr.
Facility Name
University Hospital Ostrava
City
Ostrava
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leoš Pleva, MUDr.
Facility Name
SIUN sote Hospital and Healthcare center
City
Joensuu
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tuomas Rissanen, Dr
Facility Name
CH La Rochelle
City
La Rochelle
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ludovic Meunier, Dr
Facility Name
Hôpital Jaques Cartier
City
Massy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Garot, Dr
Facility Name
CHU de Nîmes
City
Nîmes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume Cayla, Pr
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Etienne Puymirat, Prof
Facility Name
Centre Hospitalier de Pau
City
Pau
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Delarche, Dr
Facility Name
Clinique Saint Hilaire
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthieu Godin, Dr
Facility Name
Universitätsklinik Augsburg
City
Augsburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bastian Wein, Dr. med.
Facility Name
BG Klinikum Unfallkrankenhaus Berlin
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonhard Bruch, Dr.
Facility Name
Charite Campus Virchow Klinikum
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florian Krackhardt, Dr. med.
Facility Name
RKH Kliniken Bruchsal Fürst Stirum Klinik
City
Bruchsal
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Andrassy, Prof Dr med
Facility Name
Elisabeth-Krankenhaus
City
Essen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Schmitz, Dr
Facility Name
Asklepios Kliniken GmbH & Co.
City
Hamburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joachim Schofer, Prof. Dr.
Facility Name
University Medical Center Hamburg Eppendorf
City
Hamburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moritz Seiffert, PD Dr.
Facility Name
University Koeln
City
Koeln
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcel Halbach, Prof
Facility Name
MEDICLIN Herzzentrum Lahr
City
Lahr
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kambis Mashayekhi, PD Dr. med.
Facility Name
Johannes Wesling Klinikum Minden
City
Minden
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcus Wiemer, Prof.
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Geisler, Prof Dr
Facility Name
Herzklinikum Ulm
City
Ulm
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralf Birkemeyer, PD Dr
Facility Name
Ospedale Civile Santi Antonio e Biagio e Cesare Arrigo
City
Alessandria
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gioel Gabrio Secco, Dr
Facility Name
Clinica Mediterranea
City
Napoli
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlo Briguori, MD, PhD
Facility Name
Ospedale Santa Croce di Moncalieri
City
Torino
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurizio d'Amico, Dr
Facility Name
Ospedale Sant'andrea
City
Vercelli
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrizio Ugo, Dr
Facility Name
Szpital Kliniczny Przemienienia Pańskiego UM
City
Poznań
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maciej Lesiak, Prof
Facility Name
Kliniczny Szpital Wojewódzki Nr. 2 w Rzeszowie
City
Rzeszów
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamil Skoczyński
Facility Name
Szpital Ministerstwa Spraw Wewnetrznych
City
Rzeszów
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piotr Wanczura, Dr
Facility Name
University Hospital of Bern
City
Bern
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonas Dominik Haner, Dr.
Facility Name
University Hospital Geneva (HUG)
City
Geneva
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Fernando Iglesias, Dr
Facility Name
University Zurich
City
Zürich
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Stähli, Dr.
Facility Name
University Hospitals of North Midlands, Royal Stoke University Hospital
City
Stoke-on-Trent
State/Province
Staffordshire
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karim Ratib, Dr
Facility Name
The Royal Bournemouth and Christchurch Hospitals
City
Bournemouth
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter O'Kane, Dr
Facility Name
Royal Sussex County Hospital
City
Brighton
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Hildick-Smith, Prof
Facility Name
University Hospitals Bristol
City
Bristol
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom Johnson, Dr
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nick Cruden, Dr
Facility Name
Golden Jubilee National Hospital
City
Glasgow
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stuart Watkins, Dr.
Facility Name
Glenfield Hospital
City
Leicester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Ladwiniec, Dr
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eltigani Abdelaal, Dr
Facility Name
Norfolk and Norwich University Hospitals
City
Norwich
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clint Maart, Dr
Facility Name
Trent Cardiac Centre, Nottingham City Hospital
City
Nottingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Peter Vanezis, Dr
Facility Name
Royal Berkshire Hospital
City
Reading
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neil Ruparelia, Prof
Facility Name
Northern General, Sheffield
City
Sheffield
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Morgan, Dr
Facility Name
Worcestershire Royal Hospital
City
Worcester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasper Trevelyan, Dr

12. IPD Sharing Statement

Plan to Share IPD
No

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