ANEUFIX for Endoleak Type II Repair

Launched by TRIPLEMED B.V. · Apr 16, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called ANEUFIX for patients with a specific type of complication known as type II endoleak. This condition can occur after a procedure called endovascular aneurysm repair (EVAR) used to treat abdominal aortic aneurysms (AAA). The trial is looking for individuals who have a persistent type II endoleak that has been confirmed by a recent CT scan and whose aneurysm sac is growing. To be eligible, participants must be at least 18 years old, able to temporarily stop certain blood-thinning medications, and willing to undergo a procedure to address the endoleak.

Participants in this trial can expect to receive the ANEUFIX treatment at one of several international centers. The study is focused on assessing the safety and effectiveness of this treatment. It is important to note that individuals who are pregnant, have certain health issues, or are involved in other clinical trials may not be eligible to participate. Overall, this trial aims to provide valuable information on managing type II endoleaks in patients with growing aneurysm sacs after EVAR.

Gender

ALL

Eligibility criteria

• 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