An interventional study of 2D perfusion digital subtraction angiography of the foot. in Ischemia Limb, sponsored by Attikon Hospital. Completed at 1 site in Greece. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-04-22.
Sponsored by Attikon Hospital · Not applicable, Interventional, and Diagnostic
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.
2,058 studies on the registry are indexed under Ischemia; 347 are open to participants now.
This study's enrollment of 7 is below the median of 80 across 1,359 interventional studies indexed under Ischemia.
Browse Ischemia studies →Attikon Hospital is the lead sponsor of 83 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Diagnostic Test: 2D 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.
Also known as: Infrapopliteal angioplasty
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.
Time frame: 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.
Time frame: 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.
Time frame: Ten minutes before and five minutes after the intervention
Major amputation rate
The rate of above the knee target limb amputation
Time frame: Six months
Procedure-related complications
Complications noted during and after the index procedure
Time frame: 30 days
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Attikon Hospital