2D Perfusion DSA for the Quantification of Infrapopliteal Angioplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Feasibility of 2D Perfusion DSA With Custom-made, Color-coded Software for the Quantification of Foot Perfusion Following Infrapopliteal Angioplasty

Conditions
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Ischemia Limb

Intervention / Treatment
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* Diagnostic Test: 2D perfusion digital subtraction angiography of the foot.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: In total, 7 consecutive patients were included in the study. The 2D-perfusion imaging and analysis of the DICOM files were performed after revascularization.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perfusion<br>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. | Diagnostic Test: 2D perfusion digital subtraction angiography of the foot.<br>* 2D perfusion digital subtraction angiography of the foot was performed after infrapopliteal angioplasty and 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.<br>* Other names: Infrapopliteal angioplasty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Perfusion Blood Volume (PBV) | PBV calculated on subtraction images and pre- and post-procedural values were compared using the proposed 2D perfusion DSA software. | Ten minutes before and five minutes after the intervention | 
| Change in Mean Transit Time (MTT) | MTT calculated on subtraction images and pre- and post-procedural values were compared using the proposed 2D perfusion DSA software. | Ten minutes before and five minutes after the intervention | 
| Change in Perfusion Blood Flow (PBF) | PBF calculated on subtraction images and pre- and post-procedural values compared using the proposed 2D perfusion DSA software. | Ten minutes before and five minutes after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major amputation rate | The rate of above the knee target limb amputation | Six months | 
| Procedure-related complications | Complications noted during and after the index procedure | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infrapopliteal angioplasty, Tissue perfusion, Quantification