Back to resultsSaline Flush to Reduce the Amount of Residual Air Inside a Stentgraft Delivery System (SAFRANE)
Primary Purpose
Aortic Aneurysm, Aortic Aneurysm, Thoracic, Aortic Diseases
Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Increased saline flush volume
Sponsored by
About this trial
This is an interventional prevention trial for Aortic Aneurysm focused on measuring endovascular, evar, tevar, stentgraft, de-airing
Eligibility Criteria
Inclusion Criteria:
- endovascular aortic repair of an abdominal aortic aneurysm using either of these devices: Terumo/Bolton Treo, Terumo Anaconda, Cook Zenith Alpha Abdominal
Exclusion Criteria:
- concomitant use of an iliac bifurcation device due to insufficient common iliac landing zone on either side
Sites / Locations
- Heart and Vascular Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
1xIFU
4xIFU
Arm Description
Subjects in this arm are randomized to have a saline flush volume according to the IFU of the used device.
Subjects in this arm are randomized to have a saline flush volume of 4x of what is stated in the IFU of the used device.
Outcomes
Primary Outcome Measures
Air volume
Total volume of air inside the aneurysm sac on discharge CT imaging.
Secondary Outcome Measures
Full Information
NCT ID
NCT04909190
First Posted
May 26, 2021
Last Updated
July 19, 2022
Sponsor
Semmelweis University Heart and Vascular Center
1. Study Identification
Unique Protocol Identification Number
NCT04909190
Brief Title
Saline Flush to Reduce the Amount of Residual Air Inside a Stentgraft Delivery System
Acronym
SAFRANE
Official Title
A Randomized Trial of an Increased Saline Flush Protocol to Reduce the Amount of Residual Air Inside a Stentgraft Delivery System
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Semmelweis University Heart and Vascular Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Non-randomized studies have shown that de-airing of the delivery system with an increased volume of saline may be associated to a decrease in periprocedural stroke during thoracic endovascular aortic repair. This study is designed to provide evidence that 4xIFU-dose volume of saline flush vs. standard IFU-dose saline flush is associated to a decrease in the amount of intra-sac air detected on the first follow-up imaging after EVAR.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Aortic Aneurysm, Thoracic, Aortic Diseases, Aortic Arch Aneurysm, Stroke
Keywords
endovascular, evar, tevar, stentgraft, de-airing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1xIFU
Arm Type
No Intervention
Arm Description
Subjects in this arm are randomized to have a saline flush volume according to the IFU of the used device.
Arm Title
4xIFU
Arm Type
Experimental
Arm Description
Subjects in this arm are randomized to have a saline flush volume of 4x of what is stated in the IFU of the used device.
Intervention Type
Procedure
Intervention Name(s)
Increased saline flush volume
Intervention Description
Additional flushing of the stentgraft delivery system.
Primary Outcome Measure Information:
Title
Air volume
Description
Total volume of air inside the aneurysm sac on discharge CT imaging.
Time Frame
within 7 days after index procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
endovascular aortic repair of an abdominal aortic aneurysm using either of these devices: Terumo/Bolton Treo, Terumo Anaconda, Cook Zenith Alpha Abdominal
Exclusion Criteria:
concomitant use of an iliac bifurcation device due to insufficient common iliac landing zone on either side
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Csaba Csobay-Novák, MD PhD
Organizational Affiliation
Dept. of Interventional Radiology, Heart and Vascular Center, Semmelweis University
Official's Role
Study Director
Facility Information:
Facility Name
Heart and Vascular Center
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Saline Flush to Reduce the Amount of Residual Air Inside a Stentgraft Delivery System
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