Trial document




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  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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Organizational Data

  •   DRKS00014649
  •   2018/05/07
  •   2017/03/31
  •   yes
  •   Approved
  •   PV5691, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

  •   NCT03098290  (clinicaltrials.gov)
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Health Condition or Problem studied

  •   I70.2 -  Atherosclerosis of arteries of extremities
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Interventions/Observational Groups

  •   Catheter-based endovascular revascularization
  •   Endarterectomy
  •   Bypass surgery
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Other
  •   N/A
  •   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

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2018/05/01
  •   10000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   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

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    • Universitätsklinikum Hamburg-Eppendorf
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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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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    • 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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Sources of Monetary or Material Support

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    • Innovationsausschuss beim Gemeinsamen Bundesausschuss
    • Mr.  Prof. Dr.  Josef  Hecken 
    • Wegelystr. 8
    • 10623  Berlin
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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* This entry means the parameter is not applicable or has not been set.