2D Perfusion DSA for the Quantification of Infrapopliteal Angioplasty

Attikon University Hospital

Status: Completed

Conditions: Ischemia Limb

Treatments: Diagnostic Test: 2D perfusion digital subtraction angiography of the foot.

Study type: Interventional

Funder types: Other

Identifiers

NCT04356092

264/12.04.2017

Details and patient eligibility

About

A custom-made, 2D-perfusion digital subtraction angiography (PDSA) algorithm has been designed and implemented towards foot perfusion quantification following endovascular treatment of critical limb ischemia (CLI), in order to assist intra-procedural decision-making and enhance clinical outcomes.

Full description

This is a prospective, single-center, study investigating the feasibility of 2D-PDSA using newly-developed, non-commercially available, color-coded software for the quantification of foot perfusion following infrapopliteal angioplasty for the treatment of CLI. In total, 7 consecutive patients scheduled to undergo infrapopliteal endovascular treatment of CLI were enrolled. Perfusion Blood Volume (PBV), Mean Transit Time (MTT), and Perfusion Blood Flow (PBF) maps were extracted by analyzing Time-Intensity Curves and signal intensity on the perfused vessel mask. Mean values calculated from user-specified ROIs on perfusion maps were employed to evaluate the patient's pre- and post- endovascular treatment condition.

Enrollment: 7 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients prescheduled for infrapopliteal angioplasty due to chronic limb-threatening ischemia.
• Written informed consent obtained

Exclusion criteria

• Image post-processing not feasible due to significant motion artifacts produced during DSA

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Perfusion

Experimental group

Description:

Consecutive patients scheduled to undergo infrapopliteal angioplasty or stenting, or both, as part of their standard treatment for Rutherford-Becker class 5 and 6 chronic limb-threatening ischemia, were included in the study. All procedures were performed using local anesthesia. An antegrade access was used in all patients followed by the deployment of a 5 or 6 Fr arterial sheaths. A semi-lateral foot projection was preferred and the pre-revascularization DSA of the foot was performed via a 5 Fr angiographic catheter placed at the distal third of the popliteal artery. Following revascularization of one or more tibial arteries, the catheter was placed at the same popliteal segment and post-procedural DSA of the foot was performed following the exact pre-revascularization injection protocol at the same semi-lateral projection. The 2D-perfusion imaging and analysis of the DICOM files was performed after revascularization.

Treatment:

Diagnostic Test: 2D perfusion digital subtraction angiography of the foot.