2D Perfusion DSA for the Quantification of Infrapopliteal Angioplasty
- Conditions
- Ischemia Limb
- Interventions
- Diagnostic Test: 2D perfusion digital subtraction angiography of the foot.
- Registration Number
- NCT04356092
- Lead Sponsor
- Attikon Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
- Patients prescheduled for infrapopliteal angioplasty due to chronic limb-threatening ischemia.
- Written informed consent obtained
- Image post-processing not feasible due to significant motion artifacts produced during DSA
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Perfusion 2D perfusion digital subtraction angiography of the foot. 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.
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Patras University Hospital
🇬🇷Patras, Achaia, Greece