ANEUFIX for Endoleaks Type II

Abdominal Aortic Aneurysm Clinical Trial

— ACP-T5  

Official title:

Feasibility Study of Treatment Type II Endoleaks With ACP-T5: a Novel Approach.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02487290
• Other study ID #: TripleMed 001
• Status: Completed
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: December 15, 2020

Study information

• Verified date: February 2021
• Source: TripleMed B.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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'.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 15, 2020
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Endoleak

Intervention

Device:
• Aneufix 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.

Locations

Country	Name	City	State
Netherlands	Medisch Centrum Westeinde	Den Haag
Netherlands	Spaarne Gasthuisberg	Haarlem

Sponsors (2)

Lead Sponsor	Collaborator
TripleMed B.V.	Fakkel bvba

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	24h
Secondary	Clinical succes rate.	The clinical succes rate is defined as the absence of aneurysm sac growth after the procedure of ACP-T5 injection.	6 and 12 months
Secondary	Safety aspects I : intra-operative complication rate.	Intra-operative occurrence of complications.	All complications observed during the ACP-T5 injection procedure are documented.
Secondary	Safety aspects II: Peri-operative complication rate.	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.	1 month
Secondary	Safety aspects III : Mid- and long-term complication rate.	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.	1-12 months
Secondary	Aneurysm sac rupture.	The aneurysm sac rupture rate is assessed over a period of 12 months.	12 months
Secondary	Survival.	The survival rate throughout the study and up to 24 months is assessed.	24 months.