Ischemia Limb
Conditions
Keywords
Infrapopliteal angioplasty, Tissue perfusion, Quantification
Brief summary
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
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.
Interventions
DIAGNOSTIC_TEST2D perfusion digital subtraction angiography of the foot.
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.
Sponsors
University Hospital of Patras
Attikon Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Perfusion Blood Volume (PBV) | Ten minutes before and five minutes after the intervention | PBV calculated on subtraction images and pre- and post-procedural values were compared using the proposed 2D perfusion DSA software. |
| Change in Mean Transit Time (MTT) | Ten minutes before and five minutes after the intervention | MTT calculated on subtraction images and pre- and post-procedural values were compared using the proposed 2D perfusion DSA software. |
| Change in Perfusion Blood Flow (PBF) | Ten minutes before and five minutes after the intervention | PBF calculated on subtraction images and pre- and post-procedural values compared using the proposed 2D perfusion DSA software. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major amputation rate | Six months | The rate of above the knee target limb amputation |
| Procedure-related complications | 30 days | Complications noted during and after the index procedure |
Countries
Greece
Outcome results
None listed