2D Perfusion DSA for the Quantification of Infrapopliteal Angioplasty

April 18, 2020 updated by: Stavros Spiliopoulos, Attikon Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Achaia
      • Patras, Achaia, Greece, 26500
        • Patras University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Perfusion
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.
Other Names:
  • Infrapopliteal angioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Perfusion Blood Volume (PBV)
Time Frame: 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.
Ten minutes before and five minutes after the intervention
Change in Mean Transit Time (MTT)
Time Frame: 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.
Ten minutes before and five minutes after the intervention
Change in Perfusion Blood Flow (PBF)
Time Frame: 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.
Ten minutes before and five minutes after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major amputation rate
Time Frame: Six months
The rate of above the knee target limb amputation
Six months
Procedure-related complications
Time Frame: 30 days
Complications noted during and after the index procedure
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Attikon Hospital

Collaborators

University Hospital of Patras

Investigators

  • Study Chair: Dimitris Karnamatidis, MD, PhD, Patras University Hospital, Rion, Greece
  • Principal Investigator: George Kagadis, PhD, FAAPM, University of Patras, Greece

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2017

Primary Completion (Actual)

July 14, 2019

Study Completion (Actual)

July 14, 2019

Study Registration Dates

First Submitted

April 15, 2020

First Submitted That Met QC Criteria

April 18, 2020

First Posted (Actual)

April 22, 2020

Study Record Updates

Last Update Posted (Actual)

April 22, 2020

Last Update Submitted That Met QC Criteria

April 18, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 264/12.04.2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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