AneuFix - Prophylactic Sac Filling
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTripleMed B.V.
About this trial
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 criteria
Qualifiers
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
3 patent lumbars AND a CSAIMA >12,5 cm2 OR
4 patent lumbars AND a CSAIMA >10 cm2 OR
Disqualifiers
Patient not able or willing to give written Informed Consent
Patient undergoing emergency procedures
Patient undergoing EVAR for ruptured or symptomatic AAA,
Patient with a suprarenal AAA
Trial design
Treatments tested in this trial
- Prophylactic sac filling with AneuFix
Treatment groups
5 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov