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| Name | Class |
|---|---|
| University Hospital of Patras | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perfusion | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2D perfusion digital subtraction angiography of the foot. | Diagnostic Test | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dimitris Karnamatidis, MD, PhD | Patras University Hospital, Rion, Greece | Study Chair |
| George Kagadis, PhD, FAAPM | University of Patras, Greece | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Patras University Hospital | Pátrai | Achaia | 26500 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32875390 | Derived | Kagadis GC, Tsantis S, Gatos I, Spiliopoulos S, Katsanos K, Karnabatidis D. 2D perfusion DSA with an open-source, semi-automated, color-coded software for the quantification of foot perfusion following infrapopliteal angioplasty: a feasibility study. Eur Radiol Exp. 2020 Sep 2;4(1):47. doi: 10.1186/s41747-020-00176-z. |
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In total, 7 consecutive patients were included in the study. The 2D-perfusion imaging and analysis of the DICOM files were performed after revascularization.
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2D-perfusion imaging and analysis of the DICOM files was performed after revascularization, by an investigator blinded to the name of the patient or the result of the angioplasty procedure. The participant was also blinded to the results of the perfusion outcomes during follow up.
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| 30 days |