Feasibility study of treatment type II Endoleaks with ACP-T5: a novel approach

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 5

Inclusion Criteria

- Persistent type IIa or IIb endoleak (more than 6 months post-EVAR or
post-embolization procedure); AND
- Volume of the *endoleak void* can be determined upfront; AND
- An EVAR without circulatory complications; AND
- An endoleak confirmed by CT scan in preceding 8 weeks demonstrating the high
likelihood of the isolated nature of the endoleak; AND
- An aneurysm sac either growing in contours after EVAR (per European
Guidelines) as documented in the preceding 8 weeks by means of echo (or
alternative visualization technique); AND
- An aneurysm sac that can be punctured in translumbar approach; AND
- Possibility to withhold anti-thrombogenic medication temporarily; AND
- Ability and willingness to undergo the translumbar procedure under local
anesthesia in a CT scan
-Patients older than 18 years

Exclusion Criteria

- Patient not able or willing to give written Informed Consent; OR
- Patient undergoing emergency procedures; OR
- Patient with traumatic vascular injury; OR
- Patient with hemostatic disorder or who is clinically unstable; OR
- Patient with a risk of abdominal sac rupture too high to allow safe
radiological and scanographic assessments;
OR
- Patient who is allergic to contrast media or anticoagulants; OR
- Patient with renal impairment (serum creatinine > 2 mg/dl or > 176 mmol/l); OR
- Patient who is participating in another trial with an investigational drug or
medical device; OR
- Women of child bearing potential: OR
- Patient with a life expectancy of less than 12 months.

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 ACP-T5 as demonstrated by the absence of an endoleak at the end of<br /><br>the procedure.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary end-points are defined as:<br /><br>- Occurrence of general adverse events and adverse device effects at 1, 3, 6<br /><br>and 12 months and 24 months;<br /><br>- Absence of aneurysm sac growth at 6 and12 months (clinical success rate);<br /><br>- Rate of peri-operative complications (<30 days);<br /><br>- Rate of secondary endovascular or surgical re-interventions at 1, 3, 6 and 12<br /><br>months;<br /><br>- Rate of aneurysm rupture at 6 and 12months;<br /><br>- Survival throughout the study<br /><br>Safety is assessed based on the nature and severity of adverse events.</p><br>