Back to results2D Perfusion DSA for the Quantification of Infrapopliteal Angioplasty
Primary Purpose
Ischemia Limb
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
2D perfusion digital subtraction angiography of the foot.
Sponsored by
About this trial
This is an interventional diagnostic trial for Ischemia Limb focused on measuring Infrapopliteal angioplasty, Tissue perfusion, Quantification
Eligibility Criteria
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
Sites / Locations
- Patras University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Perfusion
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Major amputation rate
The rate of above the knee target limb amputation
Procedure-related complications
Complications noted during and after the index procedure
Full Information
NCT ID
NCT04356092
First Posted
April 15, 2020
Last Updated
April 18, 2020
Sponsor
Attikon Hospital
Collaborators
University Hospital of Patras
1. Study Identification
Unique Protocol Identification Number
NCT04356092
Brief Title
2D Perfusion DSA for the Quantification of Infrapopliteal Angioplasty
Official Title
Feasibility of 2D Perfusion DSA With Custom-made, Color-coded Software for the Quantification of Foot Perfusion Following Infrapopliteal Angioplasty
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
July 14, 2019 (Actual)
Study Completion Date
July 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Attikon Hospital
Collaborators
University Hospital of Patras
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia Limb
Keywords
Infrapopliteal angioplasty, Tissue perfusion, Quantification
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
In total, 7 consecutive patients were included in the study. The 2D-perfusion imaging and analysis of the DICOM files were performed after revascularization.
Masking
None (Open Label)
Masking Description
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.
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Perfusion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
2D perfusion digital subtraction angiography of the foot.
Other Intervention Name(s)
Infrapopliteal angioplasty
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Perfusion Blood Volume (PBV)
Description
PBV calculated on subtraction images and pre- and post-procedural values were compared using the proposed 2D perfusion DSA software.
Time Frame
Ten minutes before and five minutes after the intervention
Title
Change in Mean Transit Time (MTT)
Description
MTT calculated on subtraction images and pre- and post-procedural values were compared using the proposed 2D perfusion DSA software.
Time Frame
Ten minutes before and five minutes after the intervention
Title
Change in Perfusion Blood Flow (PBF)
Description
PBF calculated on subtraction images and pre- and post-procedural values compared using the proposed 2D perfusion DSA software.
Time Frame
Ten minutes before and five minutes after the intervention
Secondary Outcome Measure Information:
Title
Major amputation rate
Description
The rate of above the knee target limb amputation
Time Frame
Six months
Title
Procedure-related complications
Description
Complications noted during and after the index procedure
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitris Karnamatidis, MD, PhD
Organizational Affiliation
Patras University Hospital, Rion, Greece
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
George Kagadis, PhD, FAAPM
Organizational Affiliation
University of Patras, Greece
Official's Role
Principal Investigator
Facility Information:
Facility Name
Patras University Hospital
City
Patras
State/Province
Achaia
ZIP/Postal Code
26500
Country
Greece
12. IPD Sharing Statement
Citations:
PubMed Identifier
32875390
Citation
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.
Results Reference
derived
Learn more about this trial
2D Perfusion DSA for the Quantification of Infrapopliteal Angioplasty
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