ANEUFIX for Endoleaks Type II (ACP-T5)

TripleMed

Status: Completed

Conditions: Abdominal Aortic Aneurysm

Treatments: Device: Aneufix ACP-T5

Study type: Interventional

Funder types: Industry

Identifiers

NCT02487290

TripleMed 001

Details and patient eligibility

About

The study is a non-randomized, multi-center safety and feasibility trial of Aneufix ACP-T5 to treat patients with Isolated type II endoleak in the presence of a non-shrinking AAA sac following an EVAR procedure.

Full description

The investigational device is called Aneufix, more specifically the model ACP-T5, which is a product treating the endoleak by blockage of backflowing blood vessels, i.e. by filling the 'endoleak void and nidus of feeding artery and exit of existing draining arteries'.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Persistent type IIa or IIb endoleak (more than 6 months post-EVAR or post-embolization procedure); AND
2. Volume of the 'endoleak void' can be determined upfront; AND
3. An EVAR without circulatory complications; AND
4. An endoleak confirmed by CT scan in preceding 6 weeks demonstrating the high likelihood of the isolated nature of the endoleak; AND
5. An aneurysm sac growing in contours after EVAR (per European Guidelines) as documented in the preceding 6 weeks by means of echo (or alternative visualization technique); AND
6. An aneurysm sac that can be punctured in translumbar approach ; AND
7. Possibility to withhold anti-thrombogenic medication temporarily; AND
8. Ability and willingness to undergo the translumbar procedure under local anesthesia in a CT scan; AND
9. Be 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 hemostatic disorder 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 (serum creatinine > 2 mg/dl or > 176 mmol/l); OR
8. Patient who is participating in another trial with an investigational drug or medical device; OR
9. Women of child-bearing potential; OR
10. Patient with a life expectancy of less than 12 months.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Treatment

Experimental group

Description:

Aneufix ACP-T5

Treatment:

Device: Aneufix ACP-T5