Health TrialsbyHealthPanel

AneuFix - Prophylactic Sac Filling

ConditionsAbdominal Aortic AneurysmEndoleak
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Prophylactic sac filling with AneuFix

    Device

    ANEUFIX is administered by injection into the AAA via transferal access at the time of EVAR placement using imaging techniques to guide the place of injection.

Treatment groups

5 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Technical Success

Technical Success as demonstrated by the feasibility to fill the AAA sac after EVAR during the same procedure, and by the rate of (all) endoleaks after EVAR followed by the AneuFix procedure

Time frame
24 hours
2

Clinical Success rate

Clinical Success as demonstrated by the occurrence of type II endoleaks at 6 months after EVAR, and aneurysmal sac growth at 6 months after EVAR

Time frame
6 months
3

Clinical Success rate

Clinical Success as demonstrated by the occurrence of type II endoleaks at 12 months after EVAR, and aneurysmal sac growth at 12 months after EVAR

Time frame
12 months

Secondary outcomes

1

Intraoperative occurrence of complications

Adverse events occurring during the surgical intervention are registered.

Time frame
24 hours
2

Peri-operative complications

Rate of peri-operative complications

Time frame
30 days
3

Prevention of (any type of) endoleak

Occurrence of (any type of) endoleak

Time frame
1, 6 and 12 months
4

adverse events

Occurrence of adverse events and adverse device effects

Time frame
1, 6 and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TripleMed B.V.

Lead sponsor

Source ClinicalTrials.gov
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