2D Perfusion DSA for the Quantification of Infrapopliteal Angioplasty

NCT04356092 | Completed

• 1 other identifier: 264/12.04.2017
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemia Limb

Keywords

Infrapopliteal angioplasty; Tissue perfusion; Quantification

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Ten minutes before and five minutes after the intervention

Secondary Outcomes (2)

• Major amputation rate

  Six months

• Procedure-related complications

  30 days

Study Arms (1)

Perfusion

EXPERIMENTAL

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.

Interventions

2D perfusion digital subtraction angiography of the foot. DIAGNOSTIC_TEST

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

Perfusion

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients prescheduled for infrapopliteal angioplasty due to chronic limb-threatening ischemia.
• Written informed consent obtained

You may not qualify if:

• Image post-processing not feasible due to significant motion artifacts produced during DSA

Sponsors & Collaborators

• Attikon Hospital: lead
• University Hospital of Patras: collaborator

Study Sites (1)

Patras University Hospital

Pátrai, Achaia, 26500, Greece

Location

Related Publications (1)

• 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.

  PMID: 32875390 DERIVED

Study Officials

• Dimitris Karnamatidis, MD, PhD

  Patras University Hospital, Rion, Greece

  STUDY CHAIR

• George Kagadis, PhD, FAAPM

  University of Patras, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Interventional Radiology

Model Details: In total, 7 consecutive patients were included in the study. The 2D-perfusion imaging and analysis of the DICOM files were performed after revascularization.

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 22, 2020
• Study Start: May 2, 2017
• Primary Completion: July 14, 2019
• Study Completion: July 14, 2019
• Last Updated: April 22, 2020

Record last verified: 2020-04

Locations

GR (1)