NL-OMON54373
Recruiting
Not Applicable
Feasibility assessment of the prophylactic Use of AneuFix at the time of EVAR implantation - AneuFix - PSF
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.
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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