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

NCT04909190 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-07-20

No results posted yet for this study

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.

Conditions

  • Aortic Aneurysm
  • Aortic Aneurysm, Thoracic
  • Aortic Diseases
  • Aortic Arch Aneurysm
  • Stroke

Interventions

PROCEDURE

Increased saline flush volume

Additional flushing of the stentgraft delivery system.

Sponsors & Collaborators

  • Semmelweis University Heart and Vascular Center

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-10
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Hungary

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04909190 on ClinicalTrials.gov