SAFRANE: Saline Flush to Reduce the Amount of Residual Air Inside a Stentgraft Delivery System

• Sponsor: Semmelweis University Heart and Vascular Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04909190
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.6
• Patients Per Site Per Month: 2.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Aneurysm; Aortic Aneurysm, Thoracic; Aortic Diseases; Aortic Arch Aneurysm; Stroke	Procedure: Increased saline flush volume	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Randomized Trial of an Increased Saline Flush Protocol to Reduce the Amount of Residual Air Inside a Stentgraft Delivery System
• Actual Study Start Date: Jun 10, 2021
• Actual Primary Completion Date: Jun 30, 2022
• Actual Study Completion Date: Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 1xIFU Subjects in this arm are randomized to have a saline flush volume according to the IFU of the used device.
Experimental: 4xIFU 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.	Procedure: Increased saline flush volume; Additional flushing of the stentgraft delivery system.

Outcome Measures

Primary Outcome Measures

1. Air volume [within 7 days after index procedure]

   Total volume of air inside the aneurysm sac on discharge CT imaging.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heart and Vascular Center	Budapest		Hungary	1122

Sponsors and Collaborators

• Semmelweis University Heart and Vascular Center

Investigators

• Study Director: Csaba Csobay-Novák, MD PhD, Dept. of Interventional Radiology, Heart and Vascular Center, Semmelweis University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Csaba Csobay-Novák MD PhD, Chief radiologist, Noninvasive Imaging, Semmelweis University Heart and Vascular Center
• ClinicalTrials.gov Identifier: NCT04909190
• Other Study ID Numbers: SF2021
• First Posted: Jun 1, 2021
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Csaba Csobay-Novák MD PhD, Chief radiologist, Noninvasive Imaging, Semmelweis University Heart and Vascular Center: endovascular; evar; tevar; stentgraft; de-airing
• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Diseases; Aortic Aneurysm, Thoracic

Study Results

No Results Posted as of Jul 20, 2022