Trial document





This trial has been registered retrospectively.
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  DRKS00014192

Trial Description

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Title


Diagnostic accuracy of quantitative vascular analysis (Syngo QVA) to assess the degree of stenosis of peripheral vessel lesions compared to other examination modalities

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Patients suffering from peripheral arterial disease receive a series of diagnostic tests to find the affected constriction. For this purpose the following tests are implemented - the blood pressure measurement, ultrasound, Ratschow test, computer tomography and magnetic resonance imaging. In advanced stages an additional angiography is performed. The decision as to the extent of the disease and the associated need for therapeutic intervention is left at the discretion of the attending doctor. New computer programs allow the standardized and independent description of narrowing detected by angiography. One of these computer programs is the "QVA vascular analysis" from Siemens. Based on the X-ray images, this program evaluates the affected area and indicates the extent of the constriction in percentages. Once a constriction is determined and the level is measured, some action may be required. The accuracy of this method however has not yet been confirmed. Starting February 1st 2018 until January 31st 2019 all patients at the "Klinik für Gefäßchirurgie und endovaskuläre Chirurgie, Universitätsklinikum Heidelberg" that register for a paod-therapy/diagnosis and give their consent to participate, can be part of the study. The participation in the study is voluntary and upon completion we hope to confirm the accuracy of the QVA, so that this method can be used more routinely in the future. Also by participating in this study, patients will not be exposed to additional radiation or other additional risks. Treatment prospects do not change as a result of participating in the study. The results however may be able to help improve treatment processes which patients can benefit from in the future.

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Brief Summary in Scientific Language

Peripheral arterial disease is a disease associated with the stenosis of peripheral vessels. PAOD can be divided into the four Fontaine stages, which are based on the symptoms presented and treated. While treatment in stage I is still conservative, invasive therapy may already be required in stage II and when patients may experience claudication pain. Preinterventional diagnosis, by the means of pulse examination, Ratschow test, treadmill ergometry, ankle-brachial index, doppler ultrasonography, CTA/MRA, provide a comprehensive overview of the arterial supply of the affected extremity. However it is generally decided on the basis of non-invasive diagnostics whether or not an operation or endovascular intervention is directly indicated, or if a digital subtraction angiography (DSA) should be used to assess the treatment options further. In case of a planned endovascular intervention of a lesion, the final decision is usually made by the examiner during the DSA. His decision is based on his subjective assessment of the degree of stenosis.
The Siemens Healthcare GmbH’s QVA-Algorithm is a quantitative analysis method that allows to perform and to analyze the stenosis quantification before and after an intervention. However, as of now the diagnostic accuracy of the QVA for peripheral vascular lesions has been insufficiently validated against the gold standard (subjective assessment by the examiner during a DSA), as well as other diagnostic modalities. The aims of this study are to correlate the subjective estimation of the degree of stenosis of peripheral arterial lesions by the examiner in the DSA and the results of the pre-interventional diagnostics with the degree of stenosis determined by the QVA.

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Organizational Data

  •   DRKS00014192
  •   2018/03/12
  •   [---]*
  •   yes
  •   Approved
  •   S-582/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

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

  •   Determination of the degree of stenosis by the QVA (Quantitative Vascular Analysis) in all patients
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Characteristics

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

Determination of the sensitivity and specificity, as well as predictive values of the QVA in comparison to the subjective assessment by the examiner whether an intervention need is given

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Secondary Outcome

Determination of the sensitivity and specificity of the QVA in comparison to other preinterventional diagnostic methods

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/02/01
  •   100
  •   Monocenter 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

Planned DSA in an intervention readiness because of PAOD with iliac, femoral, or popliteo-crural lesions

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Exclusion Criteria

Allergies or renal failure make an injection of the contrast agents impossible

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Addresses

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Klinik für Gefäßchirurgie und Endovaskuläre Chirurgie
    • Mr.  PD Dr. med  Ulrich  Ronellenfitsch 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Klinik für Gefäßchirurgie und Endovaskuläre Chirurgie
    • Mr.  PD Dr. med  Ulrich  Ronellenfitsch 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Siemens Healthcare GmbH
    • Henkestr. 127
    • 91052  Erlangen
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2019/01/31
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Trial Publications, Results and other Documents

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