Clinical trial NCT02487290: ANEUFIX for Endoleaks Type II
Official title: Feasibility Study of Treatment Type II Endoleaks With ACP-T5: a Novel Approach.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Keywords: AAA
Endoleak
Lead sponsor: TripleMed B.V.
Sponsor class: INDUSTRY
Collaborators: name: Fakkel bvba
First posted: 2015-07-01
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a feasibility study, where initially 5 patients are to be treated.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.

Detailed 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'.

Eligibility criteria: 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.

Primary outcomes:
measure: Technical success of Type II endoleak repair with Aneufix ACP-T5 as demonstrated by the absence of an endoleak at the end of the procedure.
timeFrame: 24h
Secondary outcomes:
measure: Clinical succes rate.
timeFrame: 6 and 12 months
measure: Safety aspects I : intra-operative complication rate.
timeFrame: All complications observed during the ACP-T5 injection procedure are documented.
measure: Safety aspects II: Peri-operative complication rate.
timeFrame: 1 month
measure: Safety aspects III : Mid- and long-term complication rate.
timeFrame: 1-12 months
measure: Aneurysm sac rupture.
timeFrame: 12 months
measure: Survival.
timeFrame: 24 months.
Other outcomes:
Locations:
city: Den Haag
country: Netherlands
facility: Medisch Centrum Westeinde
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuisberg
Study officials:
affiliation: Medisch Centrum Westeinde Den Haag
name: Daniel Eefting, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Spaarne Gasthuis, Haarlem
name: Erik Vermeulen, Dr
role: PRINCIPAL_INVESTIGATOR
References: