Clinical trial NCT04356092: 2D Perfusion DSA for the Quantification of Infrapopliteal Angioplasty
Official title: Feasibility of 2D Perfusion DSA With Custom-made, Color-coded Software for the Quantification of Foot Perfusion Following Infrapopliteal Angioplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemia Limb
Keywords: Infrapopliteal angioplasty
Tissue perfusion
Quantification
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital of Patras
First posted: 2020-04-22
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Perfusion Blood Volume (PBV)
timeFrame: Ten minutes before and five minutes after the intervention
measure: Change in Mean Transit Time (MTT)
timeFrame: Ten minutes before and five minutes after the intervention
measure: Change in Perfusion Blood Flow (PBF)
timeFrame: Ten minutes before and five minutes after the intervention
Secondary outcomes:
measure: Major amputation rate
timeFrame: Six months
measure: Procedure-related complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Patras
country: Greece
facility: Patras University Hospital
state: Achaia
Study officials:
affiliation: Patras University Hospital, Rion, Greece
name: Dimitris Karnamatidis, MD, PhD
role: STUDY_CHAIR
affiliation: University of Patras, Greece
name: George Kagadis, PhD, FAAPM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.