ANEUFIX for Endoleaks Type II (ACP-T5)

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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: Aneufix ACP-T5

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Den Haag, Netherlands, 2512
    • Medisch Centrum Westeinde
  • Haarlem, Netherlands, 2035 RC
    • Spaarne Gasthuisberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Safety aspects I : intra-operative complication rate.	Intra-operative occurrence of complications.	All complications observed during the ACP-T5 injection procedure are documented.
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
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
Aneurysm sac rupture.	The aneurysm sac rupture rate is assessed over a period of 12 months.	12 months
Survival.	The survival rate throughout the study and up to 24 months is assessed.	24 months.

Collaborators and Investigators

• Sponsor: TripleMed B.V.
• Collaborators: Fakkel bvba
• Investigators: Principal Investigator: Daniel Eefting, Dr, Medisch Centrum Westeinde Den Haag; Principal Investigator: Erik Vermeulen, Dr, Spaarne Gasthuis, Haarlem

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2018
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): December 15, 2020

Study Registration Dates

• First Submitted: June 29, 2015
• First Submitted That Met QC Criteria: June 29, 2015
• First Posted (Estimate): July 1, 2015

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 19, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: AAA; Endoleak
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Hemorrhage; Aortic Diseases; Postoperative Hemorrhage; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Endoleak
• Other Study ID Numbers: TripleMed 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is currently no plan to share with other investigators then those participating in the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No