RecruitingNot ApplicableNCT03918460
ANEUFIX for Endoleak Type II Repair
Treatment of Type II Endoleak With ANEUFIX: Assessment of Safety, Performance and Clinical Benefit.
Sponsor
TripleMed B.V.
Enrollment
40 participants
Start Date
May 13, 2020
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria7
- Persistent type II endoleak (more than 6 months post-EVAR or post-embolization procedure); AND
- 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
- 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
- An aneurysm sac that can be punctured via a translumbar approach; AND
- Possibility to withhold anti-thrombogenic medication temporarily; AND
- Ability and willingness to undergo the translumbar procedure; AND
- Being older than 18 years.
Exclusion Criteria12
- Patient not able or willing to give written Informed Consent; OR
- Patient undergoing emergency procedures; OR
- Patient with traumatic vascular injury; OR
- Patient with haemostatic disorder (including bleeding disorders) or who is clinically unstable; OR
- Patient with a too high risk of abdominal sac rupture to allow safe radiological and scanographic assessments; OR
- Patient who is allergic to contrast media or anticoagulants; OR
- Patient with renal impairment (eGFR < 30 ml/min); OR
- Patient with a contra-indication for temporal positioning of a translumbar needle/catheter; OR
- 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
- Pre-menopausal women, OR
- Patient with a life expectancy of less than 12 months, OR
- Patient with an intra aneurysm systolic blood pressure > 125 mmHg
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Interventions
DEVICEANEUFIX
ANEUFIX is administered through translumbar injection into the AAA using imaging techniques to guide the place of injection.
Locations(9)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03918460
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