2D Perfusion DSA for the Quantification of Infrapopliteal Angioplasty

Not Applicable

Completed

• Conditions: Ischemia Limb

• Registration Number: NCT04356092
• Lead Sponsor: Attikon Hospital

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.

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 Timeline

• Study Start: 2017-05-02
• Primary Completion: 2019-07-14
• Study Completion: 2019-07-14
• Status Verified: 2020-04
• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-18
• Last Update Submitted: 2020-04-18
• Study First Posted: 2020-04-22
• Last Update Posted: 2020-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Perfusion Blood Flow (PBF)	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.
Change in Perfusion Blood Volume (PBV)	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.
Change in Mean Transit Time (MTT)	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.

Secondary Outcome Measures

Name	Time	Method
Major amputation rate	Six months	The rate of above the knee target limb amputation
Procedure-related complications	30 days	Complications noted during and after the index procedure

Trial Locations

Locations (1)

Patras University Hospital; 🇬🇷 Patras, Achaia, Greece