Digital Variance Angiography in Diagnostic Angiographies for Effective Radiation Dose Reduction

Not Applicable

Completed

• Conditions: Popliteal Stenosis; Femoral Artery Occlusion; Peripheral Artery Disease; Femoral Artery Stenosis; Iliac Artery Stenosis; Crural Artery Thrombosis; Peripheral Arterial Disease; Limb Ischemia

• Registration Number: NCT04343196
• Lead Sponsor: Kinepict Health Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-06
• Study First Submitted QC: 2020-04-09
• Study First Posted: 2020-04-13
• Study Start: 2020-04-21
• Primary Completion: 2020-09-30
• Study Completion: 2020-10-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
TASC classification	Upon completion of enrollment, approximately 1-year period	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.
Total procedural Dose-area product(DAP)	During the procedure	Indicator of a patient's irradiation dosage (microGy\*cm2 or Gy\*cm2)
Total DSA-related DAP	During the procedure	Radiation load of the patient during DSA image acquistion (microGy\*cm2 or Gy\*cm2)
Image quality review	Upon completion of enrollment, approximately 1-year period	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.

Secondary Outcome Measures

Name	Time	Method
Procedure time	During the procedure	Duration of the whole procedure, from radial artery puncture till the removal of every tool (min).
Contrast media usage	During the procedure	The volume of the iodinated contrast agent used for enhancing the image quality (mL)
Number of protocol change	During the procedure	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.

Trial Locations

Locations (1)

Semmelweis University, Heart and Vascular Center; 🇭🇺 Budapest, Hungary