Clinical Trials Directory

Trials / Completed

CompletedNCT04356092

2D Perfusion DSA for the Quantification of Infrapopliteal Angioplasty

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
7 (actual)
Sponsor
Attikon Hospital · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
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.

Timeline

Start date
2017-05-02
Primary completion
2019-07-14
Completion
2019-07-14
First posted
2020-04-22
Last updated
2020-04-22

Locations

1 site across 1 country: Greece

Source: ClinicalTrials.gov record NCT04356092. Inclusion in this directory is not an endorsement.