Digital Variance Angiography in Diagnostic Angiographies for Effective Radiation Dose Reduction

Kinepict

Status: Completed

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

Treatments: Radiation: Diagnostic Angiography (DSA or DVA based on randomization result)

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT04343196

Kinepict-008

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Group A: Low-dose DVA group

Experimental group

Description:

Image acquisition at a reduced X-ray dose, 0.36 µGy/frame (70% reduction) image processing by DVA

Treatment:

Radiation: Diagnostic Angiography (DSA or DVA based on randomization result)

Group B: Normal-dose DSA group

Active Comparator group

Description:

Image acquisition at a normal dose (1.2 µGy/frame) image processing by DSA

Treatment:

Radiation: Diagnostic Angiography (DSA or DVA based on randomization result)