Trial document





This trial has been registered retrospectively.
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  DRKS00017813

Trial Description

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Title

Quantitative evaluation of peripheral arterial blood flow using peri-interventional fluoroscopic parameters: an in vivo study evaluating feasibility and clinical utility

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aim of the study is to evaluate the use of X-ray flouroscopy-dervied curves of the vascular flow to assess treatment success during percutaneous angioplasty of vessels of the leg.

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Brief Summary in Scientific Language


In this study 10 patients with peripheral arterial disease and indication to PTA should be included retrospectively.
The aim is to evaluate the utility of different quantitative parameters which are derived from fluoroscopically acquired time-densitiy curves during angiography.
These parameters should be compared to treatment outcome to quantify treatment success.

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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

  •   DRKS00017813
  •   2019/08/30
  •   [---]*
  •   yes
  •   Approved
  •   372/2018BO2, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

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Health Condition or Problem studied

  •   I70-I79 -  Diseases of arteries, arterioles and capillaries
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Interventions/Observational Groups

  •   Patients receive a clinically driven peripheral vascular intervention. Measurement of flow-velocity with colour-coeded flouroscopy is performed out of the clinically acquired DSA images during the intervention. For this purpose a dedicated software is used to fit density-curves on the acquired DSA data. The course of the curves allows to draw conclusions on flow-parameters in the target vessel.
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Characteristics

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

Measurement of flow-velocity at the end of the intervention. The flow-velocity is then compared with the flow-velocity before treatment of the vascular target lesion.

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Secondary Outcome

Treatment success of interventional treatment at the end of the intervention. Vessel patency and technical success.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/06/01
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

symptomatic peripheral arterial disease; indication for angiography

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Exclusion Criteria

Age under 18; Preganancy, allergy to contrast agent

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Addresses

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    • Universitätsklinikum TübingenDiagnostische und Interventionelle Radiologie
    • Mr.  Prof  Konstantin  Nikolaou 
    • Hoppe-Seyler-Straße 3
    • 72076  Tübingen
    • Germany
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    • Universitätsklinikum Tübingen
    • Mr.  Priv.-Doz. Dr.  Gerd  Grözinger 
    • Hoppe-Seyler Straße 3
    • 72076  Tübingen
    • Germany
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    • Universitätsklinikum Tübingen
    • Mr.  Priv-Doz. Dr.  Gerd  Grözinger 
    • Hoppe-Seyler Straße 3
    • 72076  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Tübingen
    • Mr.  Priv-Doz. Dr.  Gerd  Grözinger 
    • Hoppe-Seyler Straße 3
    • 72076  Tübingen
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.