Treatment of type II Endoleaks with ANEUFIX: assessment of safety, performance and clinical benefit..
- Conditions
- 10002363Persistent leak
- Registration Number
- NL-OMON55992
- Lead Sponsor
- TripleMed b.v.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
1. Persistent type II endoleak (more than 6 months post-EVAR or
post-embolization procedure); AND
2. Volume of the 'endoleak void' can be estimated upfront; AND
3. An endoleak confirmed on a CT scan that should be done within 180 days prior
to procedure but preferably within 90 days prior to screening demonstrating the
high likelihood of the isolated nature of the endoleak; AND
4. An aneurysm sac growing after EVAR of minimal 10 mm (per European
Guidelines) as documented in the preceding 90 days by means of CT-imaging
(alternative imaging technique) and based upon sac diameter measurements; AND
5. An aneurysm sac that can be punctured in translumbar approach; AND
6. Possibility to withhold anti-thrombogenic medication temporarily; AND
7. Ability and willingness to undergo the translumbar procedure; AND
8. Be older than 18 years.
1. Patient not able or willing to give written Informed Consent themselves; OR
2. Patient undergoing emergency procedures; OR
3. Patient with traumatic vascular injury; OR
4. Patient with an untreated endoleak connected to an open AMI (patients
can be included if the AMI is coiled or is technically not possible to be
coiled prior the Aneufix application); OR
5. Patient with hemostatic disorder (including bleeding disorders) or who is
clinically unstable; OR
6. Patient with a too high risk of abdominal sac rupture to allow safe
radiological and scanographic assessments; OR
7. Patient who is allergic to contrast media or anticoagulants; OR
8. Patient with renal impairment (eGRF < 30 ml/min); OR
9. Patient with a contra-indication for temporal positioning of a translumbar
needle/catheter; OR
10. Patient who is participating in another trial with an investigational drug
or medical device or where a medical device/drug is used outside its labelling
and its approved intended use; OR
11. Pre-menopausal women, OR
12. Patient with a life expectancy of less than 12 months; OR
13. Patient with an intra aneurysm systolic blood pressure > 125 mmHg
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary end-point is defined as *Technical success of Type II endoleak repair<br /><br>with ANEUFIX as demonstrated by the absence of endoleak circulation at the<br /><br>intended treated endoleak at the end of the procedure*. The presence or<br /><br>absence of the endoleak treated with Aneufix is verified by means of a CT scan<br /><br>the next day.</p><br>
- Secondary Outcome Measures
Name Time Method