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Completed

NCT Number: NCT04356092

2D Perfusion DSA for the Quantification of 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.

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Key information

Conditions

Ischemia Limb

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Patras University Hospital

Pátrai, Achaia, 26500, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Infrapopliteal angioplasty

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Major amputation rate

    Time frame: Six months

    The rate of above the knee target limb amputation

  2. Procedure-related complications

    Time frame: 30 days

    Complications noted during and after the index procedure

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Collaborators

  • University Hospital of Patras

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 22, 2020
Registry last updated
Apr 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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