Trial document

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DRKS-ID: DRKS00014649

Trial Description

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Title

GermanVasc-Registry within the IDOMENEO study

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Trial Acronym

IDOMENEO

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URL of the Trial

http://www.idomeneo.de

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Brief Summary in Lay Language

The government-funded registry-based IDOMENEO-study will consecutively include 10,000 patients with invasive revascularisations for symptomatic peripheral arterial disease performed at approximately 30-40 German vascular centres utilizing the GermanVasc registry system.

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Brief Summary in Scientific Language

The study is a prospective non-randomized registry trial including invasive endovascular (ER) and open-surgical (OR) revascularisations of chronic symptomatic peripheral arterial disease (PAD) of the lower extremities performed in 30-40 legally endorsed multidisciplinary German hospitals. All patients matching the inclusion criteria are consecutively included for an enrolment period of six months or until 10,000 patients have been included in the study registry. There are three follow-up measures at 3 months, 6 months and 12 months. The study outcomes consist of indicators of outcome quality defined by consensual agreement among experts in the field of vascular medicine. Plausibility-checks for integrity of submitted data are implemented into the registry system and all data needs to be verified by a physician employed in the participating study centre. Furthermore, the study data will undergo an independent quality assurance for internal validity by random-sample cross-checking against local patient files.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

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Organizational Data

DRKS-ID: DRKS00014649
Date of Registration in DRKS: 2018/05/07
Date of Registration in Partner Registry or other Primary Registry: 2017/03/31
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: PV5691, Ethik-Kommission der Ärztekammer Hamburg

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Secondary IDs

Primary Registry-ID: NCT03098290 (clinicaltrials.gov)

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Health Condition or Problem studied

ICD10: I70.2 - Atherosclerosis of arteries of extremities

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Interventions/Observational Groups

Arm 1: Catheter-based endovascular revascularization
Arm 2: Endarterectomy
Arm 3: Bypass surgery

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Characteristics

Study Type: Non-interventional
Study Type Non-Interventional: Epidemiological study
Allocation: Other
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Other
Purpose: Treatment
Assignment: Other
Phase: N/A
Off-label Drug use: N/A

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Primary Outcome

Before discharge, after 3 months, after 6 months, after 12 months:
Major Adverse Cardiovascular Events (MACE)
Major Adverse Limb Events (MALE)
Myocardial Infarction
Stroke or TIA
Major Amputation
Major Reintervention
Any Reintervention
Wound Infection
Vascular Access-related Major Complication
Maximum Walking Distance
Rutherford-Classification
Ankle-Brachial-Index

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Secondary Outcome

Evaluated at time of discharge, after 3 months, after 6 months, and after 12 months:
Minor Amputation
Primary Patency
Secondary Patency
Quality of Life
Healing of Wound Infections or Wound Healing Disorders
Lymphatic Fistula
Ambulation
Technical Success
Patient Satisfaction
Total Length of Hospital Stay
Functional Status
Hospital-acquired Infection
Cathether-related Infection
Ankle-Brachial-Index

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Countries of Recruitment

DE: Germany

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Locations of Recruitment

Medical Center Universitätsklinikum Hamburg-Eppendorf, Hamburg
Medical Center Agaplesion Diakonie Kliniken Kassel, Kassel
Medical Center Agaplesion Diakonieklinikum Hamburg, Hamburg
Medical Center Asklepios Klinik Birkenwerder, Birkenwerder
Medical Center Carl-Thiem-Klinikum Cottbus, Cottbus
Medical Center Charité Universitätsmedizin Berlin (Campus Benjamin Franklin), Berlin
Medical Center Elisabeth-Krankenhaus Essen, Essen
Medical Center Ev. Krankenhaus Mühlheim an der Ruhr, Mühlheim an der Ruhr
Medical Center Frankfurter RotKreuz-Kliniken e.V., Frankfurt a.M.
Medical Center Friedrich-Ebert-Krankenhaus Neumünster, Neumünster
Medical Center Gemeinschaftskrankenhaus Bonn (Haus St. Petrus), Bonn
Medical Center GFO Kliniken Bonn (Betriebsstätte St. Marien), Bonn
Medical Center Helios Klinikum Berlin-Buch, Berlin
Medical Center Helios Klinikum Erfurt, Erfurt
Medical Center Herz- und Gefäßzentrum Bad Bevensen, Bad Bevensen
Medical Center Isarklinikum München, München
Medical Center Kath. Karl-Leisner-Klinikum I Marienhospital Kevelaer, Kevelaer
Medical Center Kerckhoff-Klinik Bad Nauheim, Bad Nauheim
Medical Center Klinikum Chemnitz gGmbH, Chemnitz
Medical Center Klinikum Darmstadt GmbH, Darmstadt
Medical Center Klinikum Magdeburg gGmbH, Magdeburg
Medical Center Klinikum Mutterhaus der Borromäerinnen gGmbH (Mitte), Trier
Medical Center Klinikum Rheine I Mathias Spital, Rheine
Medical Center Klinikum Stadt Soest, Soest
Medical Center SRH-Klinikum-Karlsbad-Langensteinbach, Karlsbad
Medical Center Städtisches Klinikum Karlsruhe, Karlsruhe
Medical Center Städtisches Klinikum Dresden Friedrichstadt, Dresden
Medical Center Theresienkrankenhaus Mannheim, Mannheim
Medical Center Universitäres Herzzentrum Hamburg GmbH, Hamburg
Medical Center Universitäts-Herzzentrum Freiburg (Standort Bad Krozingen), Freiburg im Breisgau
Medical Center Universitäts-Herzzentrum Freiburg (Standort Freiburg), Freiburg im Breisgau
Medical Center Universitätsklinikum Jena, Jena
Medical Center Universitätsklinikum Schleswig-Holstein (Campus Kiel), Kiel
Medical Center Universitätsklinikum Schleswig-Holstein (Campus Lübeck), Lübeck
Medical Center Zentralklinik Bad Berka GmbH, Bad Berka

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2018/05/01
Target Sample Size: 10000
Monocenter/Multicenter trial: Multicenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: no maximum age

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Additional Inclusion Criteria

Invasive open-surgical (endarterectomy, bypass surgery) or catheter-based endovascular revascularizations of symptomatic peripheral arterial disease

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Exclusion Criteria

No informed consent
Patient <18 years

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Addresses

Primary Sponsor
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- Universitätsklinikum Hamburg-Eppendorf
- Martinistr. 52
- 20246 Hamburg
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.uke.de
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Contact for Scientific Queries
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- Universitätsklinikum Hamburg-Eppendorf,Klinik und Poliklinik für Gefäßmedizin,Arbeitsgruppe GermanVasc
- Mr. Dr. med. Christian-Alexander Behrendt
- Martinistr. 52
- 20246 Hamburg
- Germany
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- Telephone: 0049-40-7410-18087
- Fax: 0049-40-7410-54840
- E-mail: ch.behrendt at uke.de
- URL: http://www.uke.de
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Contact for Public Queries
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- Universitätsklinikum Hamburg-Eppendorf,Klinik und Poliklinik für Gefäßmedizin,Arbeitsgruppe GermanVasc
- Mr. Dr. med. Christian-Alexander Behrendt
- Martinistr. 52
- 20246 Hamburg
- Germany
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- Telephone: 0049-40-7410-18087
- Fax: 0049-40-7410-54840
- E-mail: ch.behrendt at uke.de
- URL: http://www.uke.de
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Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
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- Innovationsausschuss beim Gemeinsamen Bundesausschuss
- Mr. Prof. Dr. Josef Hecken
- Wegelystr. 8
- 10623 Berlin
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: info at if.g-ba.de
- URL: [---]*
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Status

Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*

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Trial Publications, Results and other Documents

Approval of ethics comm. (mandatory for transfer to Studybox): Ethikvotum der federführenden Ethikkommission Hamburg
Paper: Behrendt CA, et al. IDOMENEO - Ist die Versorgungsrealität in der Gefäßmedizin Leitlinien und Versorgungsgerecht. Gefässchirurgie 2017;22:41-47.
Paper: Behrendt CA, et al. Leitlinienempfehlungen in der PAVK Therapie. Bundesgesundheitsbl 2018;61:218-223.

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