Feasibility Assessment of the Prophylactic Use of AneuFix at the Time of EVAR Implantation

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study is set up to assess the feasibility and safety of the clinical procedure using AneuFix in a prophylactic setting at the time of EVAR endograft implantation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Asymptomatic, infrarenal AAA that requires surgery with a high-risk profile of developing endoleak type II in line with the recommendations of Guntner et al:

• \- Open IMA AND

⁃ 1 patent lumbar AND a cross-sectional area at the location of the IMA (CSAIMA) \>17,5cm2 OR

⁃ 2 patent lumbars AND a CSAIMA \>15cm2 OR

⁃ 5 patent lumbars AND a CSAIMA \>7,5 cm2

• Infrarenal neck according to the IFU of the EVAR device

• Other aortic-iliac anatomical configuration suitable for EVAR according to the criteria of the EVAR device to be used

• Patient having a life expectation of at least 2 years

• Being older than 18 years

• Willing and able to comply with the requirements of this clinical study

Locations
Other Locations
Netherlands
VUmc
RECRUITING
Amsterdam
Contact Information
Primary
Florie Daniels
f.daniels@triple-med.com
+31 6 38 19 92 91
Backup
Tjeerd Homsma
t.homsma@triple-med.com
+31 6 29 07 80 03
Time Frame
Start Date: 2022-02-15
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 5
Treatments
Experimental: Intervention
Device: ANEUFIX
Sponsors
Leads: TripleMed B.V.

This content was sourced from clinicaltrials.gov