Abdominal Aortic Aneurysm
Conditions
Keywords
AAA, Endoleak
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'.
Interventions
DEVICEAneufix ACP-T5
The ACP-T5 is injected via translumbar approach into the aneurysm sac near the entrance/exit of bloodvessel. ACP-T5 will cure and block the endoleak.
Sponsors
Fakkel bvba
TripleMed B.V.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
This is a feasibility study, where initially 5 patients are to be treated.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 24h | At the end of the injection procedure, the technical success will be determined by angiographic recording and physician assessment of absence of endoleak. CT scan at 24 hrs is obtained to reconfirm the absence of endoleak. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety aspects I : intra-operative complication rate. | All complications observed during the ACP-T5 injection procedure are documented. | Intra-operative occurrence of complications. |
| Safety aspects II: Peri-operative complication rate. | 1 month | All complications as well as the occurrence of adverse events and adverse device effects during the period of 24 hrs - 1 month are observed, documented, adjudicated and reported. adverse device effects are observed, documented, adjudicated and reported. |
| Clinical succes rate. | 6 and 12 months | The clinical succes rate is defined as the absence of aneurysm sac growth after the procedure of ACP-T5 injection. |
| Aneurysm sac rupture. | 12 months | The aneurysm sac rupture rate is assessed over a period of 12 months. |
| Survival. | 24 months. | The survival rate throughout the study and up to 24 months is assessed. |
| Safety aspects III : Mid- and long-term complication rate. | 1-12 months | All complications as well as the occurrence of adverse events and adverse device effects during the period of 1-12 months are observed, documented, adjudicated and reported. adverse device effects are observed, documented, adjudicated and reported. |
Countries
Netherlands
Outcome results
None listed