Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00013585

Trial Description

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Title

RECCORD (Recording Courses of Vascular Diseases) Registry

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Trial Acronym

RECCORD

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URL of the Trial

https://www.reccord.de

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Brief Summary in Lay Language

Vascular Registry of Deutschen Gesellschaft für Angiologie - Gesellschaft für Gefäßmedizin e.V.

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Brief Summary in Scientific Language

The RECording COurses of vasculaR Diseases registry (RECCORD registry) is an observational, prospective, multicentre, all-comers registry platform.
In the initial phase, patients referred for endovascular revascularization of peripheral artery disease (PAD) of the lower limbs will be prospectively included and followed up for at least one year.
At baseline, data on patients' demographic characteristics, comorbidities, previous peripheral interventions, medication, and clinical stage of PAD (Rutherford category), haemodynamic parameters, and procedural data including complications will be assessed.
Major adverse cardiac and limb events will be recorded at planned (at six and 12 months) and at any unplanned visits.
For details see NM Malyar et al., Rationale and design of the RECording COurses of vasculaR Diseases registry (RECCORD registry). Vasa. https://doi.org/10.1024/0301-1526/a000631

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Organizational Data

  •   DRKS00013585
  •   2018/02/23
  •   [---]*
  •   yes
  •   Approved
  •   17-611, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  •   U1111-1209-6562 
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Health Condition or Problem studied

  •   I70 -  Atherosclerosis
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Interventions/Observational Groups

  •   Patients referred for endovascular revascularization of peripheral artery disease (PAD) of the lower limbs will be prospectively included in the registry and followed up for at least one year. At baseline, data on patients' demographic characteristics, comorbidities, previous peripheral interventions, medication, and clinical stage of PAD (Rutherford category), haemodynamic parameters, and procedural data including complications will be assessed. Major adverse cardiac and limb events will be recorded at planned (at six and 12 months) and at any unplanned visits. The RECCORD registry will provide a comprehensive dataset depicting the current real life practice and outcome of vascular care.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

1. Peri- and post-interventional complications (puncture-site complications & intervention-related complications over 30 days), 2. Amputations, 3. Survival

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Secondary Outcome

4. Quality of Life, 5. Re-Intervention

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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 
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Recruitment

  •   Actual
  •   2018/01/01
  •   6000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

- any type of endovascular interventions for symptomatic PAD
- endovascular intervention for PAD of lower extremities, i.e. below the aorto-iliac bifurcation

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Exclusion Criteria

- patients undergoing hybrid-(surgical and endovascular) and/or surgical interventions for symptomatic PAD
- patients with a life expectancy of <6 months
- endovascular intervention for reasons other than symptomatic PAD

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Deutsche Gesellschaft für Angiologie - Gesellschaft für Gefäßmedizin e.V.
    • Mr.  Prof. Dr. med.  Sebastian  Schellong 
    • Schiffbauerdamm 40
    • 10117  Berlin
    • Germany
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    • emil GmbH
    • Mr.  Marco  Tränkle 
    • Deichelweiherweg 1
    • 79102  Freiburg
    • Germany
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  • start of 1:1-Block address scientific-contact
    • emil GmbH
    • Mr.  Marco  Tränkle 
    • Deichelweiherweg 1
    • 79102  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
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    end of 1:1-Block address contact scientific-contact
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    • emil GmbH
    • Mr.  Marco  Tränkle 
    • Deichelweiherweg 1
    • 79102  Freiburg
    • Germany
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    end of 1:1-Block address contact public-contact
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Sources of Monetary or Material Support

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    • Deutsche Gesellschaft für Angiologie - Gesellschaft für Gefäßmedizin e.V.
    • Mr.  Prof. Dr. med.  Sebastian  Schellong 
    • Schiffbauerdamm 40
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  •   URL: http://econtent.hogrefe.com/doi/pdf/10.1024/0301-1526/a000631 Description: Rationale and design of the RECording COurses of vasculaR Diseases registry (RECCORD registry), Vasa (2017), 46, pp. 262-267
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* This entry means the parameter is not applicable or has not been set.