ANEUFIX for Endoleaks Type II

NCT02487290 | Completed DMC

• 1 other identifier: TripleMed 001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

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.

Conditions

Abdominal Aortic Aneurysm

Keywords

AAA; Endoleak

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Clinical succes rate.

  6 and 12 months

• Safety aspects I : intra-operative complication rate.

  All complications observed during the ACP-T5 injection procedure are documented.

• Safety aspects II: Peri-operative complication rate.

  1 month

• Safety aspects III : Mid- and long-term complication rate.

  1-12 months

• Aneurysm sac rupture.

  12 months

Study Arms (1)

Treatment

EXPERIMENTAL

Aneufix ACP-T5

Device: Aneufix ACP-T5

Interventions

Aneufix ACP-T5 DEVICE

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.

Also known as: ANEUFIX

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TripleMed B.V.: lead
• Fakkel bvba: collaborator

Study Sites (2)

Spaarne Gasthuisberg

Haarlem, 2035 RC, Netherlands

Location

Medisch Centrum Westeinde

The Hague, 2512, Netherlands

Location

Related Publications (1)

• Smorenburg SPM, Lely RJ, Kelckhoven BV, Vermeulen EG, Yeung KK, Kruse RR, Kraai M, Stassen CM, Jacobs MJ, Hoksbergen AWJ. Initial Clinical Experience With AneuFix Injectable Biocompatible Elastomer for Translumbar Embolization of Type 2 Endoleaks. J Endovasc Ther. 2025 Feb;32(1):57-67. doi: 10.1177/15266028231165731. Epub 2023 Apr 19.

  PMID: 37073926 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Endoleak

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Postoperative Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Study Officials

• Daniel Eefting, Dr

  Medisch Centrum Westeinde Den Haag

  PRINCIPAL INVESTIGATOR

• Erik Vermeulen, Dr

  Spaarne Gasthuis, Haarlem

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 1, 2015
• Study Start: February 26, 2018
• Primary Completion: February 1, 2019
• Study Completion: December 15, 2020
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)