Active, not recruiting
Not applicable
ANEUFIX for Endoleak Type II Repair
Condition(s) studied
Abdominal Aortic AneurysmEndoleak
Investigational drug(s) / intervention(s)
ANEUFIX
ANEUFIX: ANEUFIX is administered through translumbar injection into the AAA using imaging techniques to guide the place of injection.
Study summary
The study is non-randomized, multicenter international safety, performance and clinical benefit outcome assessment of ANEUFIX to treat patients with isolated type II endoleak in the presence of a growing AAA-sac following an EVAR procedure more than 6 months ago.
Eligibility
Inclusion Criteria:
1. Persistent type II endoleak (more than 6 months post-EVAR or post-embolization procedure); AND
2. 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
3. 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 (or alternative imaging techniques) and based upon sac diameter measurements; AND
4. An aneurysm sac that can be punctured via a translumbar approach; AND
5. Possibility to withhold anti-thrombogenic medication temporarily; AND
6. Ability and willingness to undergo the translumbar procedure; AND
7. Being older than 18 years.
Exclusion Criteria:
1. Patient not able or willing to give written Informed Consent; OR
2. Patient undergoing emergency procedures; OR
3. Patient with traumatic vascular injury; OR
4. Patient with haemostatic disorder (including bleeding disorders) or who is clinically unstable; OR
5. Patient with a too high risk of abdominal sac rupture to allow safe radiological and scanographic assessments; OR
6. Patient who is allergic to contrast media or anticoagulants; OR
7. Patient with renal impairment (eGFR \< 30 ml/min); OR
8. Patient with a contra-indication for temporal positioning of a translumbar needle/catheter; OR
9. 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
10. Pre-menopausal women, OR
11. Patient with a life expectancy of less than 12 months, OR
12. Patient with an intra aneurysm systolic blood pressure \> 125 mmHg
Primary outcome measure(s)
- Technical success rate — 24 hours
Technical success of Type II endoleak repair with Aneufix as demonstrated by the absence of endoleak circulation at the intended treated endoleak at the end of the procedure; presence or absence of the endoleak treated with ANEUFIX is verified by means of a CT scan the next day.
Trial sites (9)
| Facility | City | Region | Status |
| Imelda |
Bonheiden |
Belgium |
|
| ZOL |
Genk |
Belgium |
|
| UZ Leuven |
Leuven |
Belgium |
|
| ZGT |
Almelo |
Netherlands |
|
| Amsterdam UMC - VUmc |
Amsterdam |
Netherlands |
|
| OLVG |
Amsterdam |
Netherlands |
|
| Rijnstate |
Arnhem |
Netherlands |
|
| Spaarne Gasthuis |
Haarlem |
Netherlands |
|
| ETZ |
Tilburg |
Netherlands |
|
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