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Clinical Trials/NL-OMON54373
NL-OMON54373
Recruiting
Not Applicable

Feasibility assessment of the prophylactic Use of AneuFix at the time of EVAR implantation - AneuFix - PSF

TripleMed B.V.0 sites5 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endoleak
Sponsor
TripleMed B.V.
Enrollment
5
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. Asymptomatic, infrarenal AAA that requires surgery with a high\- risk profile
  • of developing endoleak type II
  • 2\. Infrarenal neck according to the IFU of the EVAR device
  • 3\. Other aortic\-iliac anatomical configuration suitable for EVAR according to
  • the criteria of the EVAR device to be used
  • 4\. Patient having a life expectation of at least 2 years
  • 5\. Being older than 18 years
  • 6\. Willing and able to comply with the requirements of this clinical study

Exclusion Criteria

  • 1\. Patient not able or willing to give written Informed Consent
  • 2\. Patient undergoing emergency procedures
  • 3\. Patient undergoing EVAR for ruptured or symptomatic AAA,
  • 4\. Patient with a suprarenal AAA
  • 5\. Patient with an inflammatory AAA (more than minimal wall thickening)
  • 6\. Patient with an infrarenal neck unsuitable for endovascular fixation
  • (including so called \*hostile necks\*) or aortic\-iliac anatomic configuration
  • otherwise unsuitable for EVAR according to criteria of the device to be used
  • 7\. Patient in which a bilateral retroperitoneal incision is required for EVAR
  • 8\. Patient in which a sacrifice of both hypogastric arteries is required

Outcomes

Primary Outcomes

Not specified

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