ACP-T5: ANEUFIX for Endoleaks Type II

Sponsor

TripleMed B.V. (Industry)

Overall Status

Completed

CT.gov ID

NCT02487290

Collaborator

Fakkel bvba (Industry)

Enrollment

Locations

Arm

33.6

Actual Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aortic Aneurysm	Device: Aneufix ACP-T5	N/A

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'.

Study Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This is a feasibility study, where initially 5 patients are to be treated.This is a feasibility study, where initially 5 patients are to be treated.

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

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

Actual Study Start Date :

Feb 26, 2018

Actual Primary Completion Date :

Feb 1, 2019

Actual Study Completion Date :

Dec 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Aneufix ACP-T5	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. Other Names: ANEUFIX

Arm

Intervention/Treatment

Experimental: Treatment

Aneufix ACP-T5

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.

Other Names:

ANEUFIX

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Persistent type IIa or IIb endoleak (more than 6 months post-EVAR or post-embolization procedure); AND
Volume of the 'endoleak void' can be determined upfront; AND
An EVAR without circulatory complications; AND
An endoleak confirmed by CT scan in preceding 6 weeks demonstrating the high likelihood of the isolated nature of the endoleak; AND
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
An aneurysm sac that can be punctured in translumbar approach ; AND
Possibility to withhold anti-thrombogenic medication temporarily; AND
Ability and willingness to undergo the translumbar procedure under local anesthesia in a CT scan; AND
Be older than 18 years.

Exclusion Criteria:

Patient not able or willing to give written Informed Consent; OR
Patient undergoing emergency procedures; OR
Patient with traumatic vascular injury; OR
Patient with hemostatic disorder 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 (serum creatinine > 2 mg/dl or > 176 mmol/l); OR
Patient who is participating in another trial with an investigational drug or medical device; OR
Women of child-bearing potential; OR
Patient with a life expectancy of less than 12 months.