Peripheral Arterial Disease Clinical Trial
Official title:
Application of Digital Variance Angiography in Diagnostic Lower Limb Angiographiy for Radiation Exposure Reduction a Prospective Randomized Clinical Trial
Verified date | September 2021 |
Source | Kinepict Health Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Digital Variance Angiography (DVA) is a new tool in medical imaging with proven image quality reserve. The previously observed quality reserve of Digital Variance Angiography (DVA) in lower extremity angiographies, allowed to lower radiation exposure by 70 % during DSA in lower extremity diagnostic angiographies with non-inferior image quality. The aim of this study is to apply this non-inferior image quality and use it for radiation exposure reduction in diagnostic lower limb angiography. The project would prospectively block-randomise (50:50) patients, who undergo elective diagnostic angiography into two groups: a comparator group examined by means of conventional DSA using a standard care protocol (Siemens Artis Zee, Extremities Care setting, 1.2 µGy/frame) (Group B) and a study group examined by means of DVA using a low-dose protocol (0.36 µGy/frame corresponding to 70% decrease of radiation dose) (Group A). During each procedure the investigators record radiation exposure (cumulative dosage, dose area product) and contrast media usage and procedural time then compare the results of the groups. Qualitative image review is done to compare conventional DSA and reduced radiation exposure DVA images after image acquisition. Our hypothesis is that with the previously proven non-inferior image quality, the investigators will be able to reduce radiation exposure of the participants and also staff members in everyday clinical practice.
Status | Completed |
Enrollment | 114 |
Est. completion date | October 30, 2020 |
Est. primary completion date | September 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Patients with lower limb peripheral arterial disease, admitted for diagnostic angiography - Fontaine II- IV - Normal renal function: GFR> 60ml/min/m2 - Age > 18 Exclusion Criteria: - Acute myocardial infarction - Severe heart/liver/renal failure - Iodine contrast allergy - Atrioventricular block - Coagulopathy and Hematological Bleeding Disorders |
Country | Name | City | State |
---|---|---|---|
Hungary | Semmelweis University, Heart and Vascular Center | Budapest |
Lead Sponsor | Collaborator |
---|---|
Kinepict Health Ltd. | Semmelweis University Heart and Vascular Center |
Hungary,
Gyánó M, Góg I, Óriás VI, Ruzsa Z, Nemes B, Csobay-Novák C, Oláh Z, Nagy Z, Merkely B, Szigeti K, Osváth S, Sótonyi P. Kinetic Imaging in Lower Extremity Arteriography: Comparison to Digital Subtraction Angiography. Radiology. 2019 Jan;290(1):246-253. doi: 10.1148/radiol.2018172927. Epub 2018 Oct 16. — View Citation
Óriás VI, Gyánó M, Góg I, Szöllosi D, Veres DS, Nagy Z, Csobay-Novák C, Zoltán O, Kiss JP, Osváth S, Szigeti K, Zoltán R, Sótonyi P. Digital Variance Angiography as a Paradigm Shift in Carbon Dioxide Angiography. Invest Radiol. 2019 Jul;54(7):428-436. doi: 10.1097/RLI.0000000000000555. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total procedural Dose-area product(DAP) | Indicator of a patient's irradiation dosage (microGy*cm2 or Gy*cm2) | During the procedure | |
Primary | Total DSA-related DAP | Radiation load of the patient during DSA image acquistion (microGy*cm2 or Gy*cm2) | During the procedure | |
Primary | Image quality review | Blinded, anonymised and randomised qualitative review and comparison of images by multiple endovascular specialists in multiple regions using a 1-5 Likert-scale for each image. Region specific scores are compared between DSA and DVA technique. | Upon completion of enrollment, approximately 1-year period | |
Primary | TASC classification | Blinded, anonymised and randomised review of images by multiple endovascular specialists. Clinically relevant sides for each patient are reviewed in a separate questionnaire: each reviewer have to classify each patient's angiographic image according to the Trans-Atlantic Inter-Society Consensus Document's second version. | Upon completion of enrollment, approximately 1-year period | |
Secondary | Contrast media usage | The volume of the iodinated contrast agent used for enhancing the image quality (mL) | During the procedure | |
Secondary | Number of protocol change | The number of occasions when the reduced radiation level protocol has to be switched back to conventional protocol in one region because of unsuitable image quality. | During the procedure | |
Secondary | Procedure time | Duration of the whole procedure, from radial artery puncture till the removal of every tool (min). | During the procedure |
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