2D Perfusion DSA for the Quantification of Infrapopliteal Angioplasty

Ischemia Limb Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04356092
• Other study ID #: 264/12.04.2017
• Status: Completed
• Phase: N/A
• Start date: May 2, 2017
• Est. completion date: July 14, 2019

Study information

• Verified date: April 2020
• Source: Attikon Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 14, 2019
• Est. primary completion date: July 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemia Limb

Intervention

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.

Locations

Country	Name	City	State
Greece	Patras University Hospital	Patras	Achaia

Sponsors (2)

Lead Sponsor	Collaborator
Attikon Hospital	University Hospital of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Major amputation rate	The rate of above the knee target limb amputation	Six months
Secondary	Procedure-related complications	Complications noted during and after the index procedure	30 days