Condition or disease | Intervention/treatment | Phase |
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Abdominal Aortic Aneurysm Endoleak | Device: ANEUFIX | Not Applicable |
The investigational device is called ANEUFIX, 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.
ANEUFIX is a polymer that cures rapidly (7 min at 37°C) after injection into the AAA-sac close to the nidus.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | The current study is a follow up study on the previous feasibility study where ACP-T5 was used; after increasing the % tantalum in ANEUFIX to make the product more detectable under X-ray, the current study evaluates the end-points in a total of 25 patients. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Treatment of Type II Endoleak With ANEUFIX: Assessment of Safety, Performance and Clinical Benefit. |
Actual Study Start Date : | May 13, 2020 |
Estimated Primary Completion Date : | September 2021 |
Estimated Study Completion Date : | December 2022 |
Arm | Intervention/treatment |
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Experimental: Intervention
All patients enrolled are intended to be treated
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Device: ANEUFIX
ANEUFIX is administered through translumbar injection into the AAA using imaging techniques to guide the place of injection.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Diedelinde Persijn, MSc | +32471437477 | dp@triumclinicalconsulting.com |
Netherlands | |
Amsterdam UMC - VUmc | Recruiting |
Amsterdam, Netherlands | |
Contact: Arjan WJ Hoksbergen, Dr |
Principal Investigator: | Arjan WJ Hoksbergen, Dr | VUmc Heelkunde, Amsterdam |
Tracking Information | |||||
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First Submitted Date ICMJE | April 12, 2019 | ||||
First Posted Date ICMJE | April 17, 2019 | ||||
Last Update Posted Date | April 6, 2021 | ||||
Actual Study Start Date ICMJE | May 13, 2020 | ||||
Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Technical success rate [ Time Frame: 24 hours ] Technical success of Type II endoleak repair with Aneufix as demonstrated by the absence of endoleak circulation at the end of the procedure; presence or absence of endoleak is verified by means of CT scan at the end of or soon after the Aneufix injection procedure, i.e. within 24 hrs after the completion of the injection procedure.
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Original Primary Outcome Measures ICMJE |
Technical success. [ Time Frame: 24 hours ] Technical success of Type II endoleak repair with Aneufix ACP-T20 as demonstrated by the absence of an endoleak at the end of the procedure; presence of endoleak is verified by means of CT scan at the end of the ACP-T20 procedure
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | ANEUFIX for Endoleak Type II Repair | ||||
Official Title ICMJE | Treatment of Type II Endoleak With ANEUFIX: Assessment of Safety, Performance and Clinical Benefit. | ||||
Brief Summary | The study is non-randomized, multicenter international safety, performance and clinical benefit outcome assessment of ANEUFIX to treat patients with isolated type II endoleak in the presence of a growing AAA-sac following an EVAR procedure more than 6 months ago. | ||||
Detailed Description |
The investigational device is called ANEUFIX, 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. ANEUFIX is a polymer that cures rapidly (7 min at 37°C) after injection into the AAA-sac close to the nidus. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: The current study is a follow up study on the previous feasibility study where ACP-T5 was used; after increasing the % tantalum in ANEUFIX to make the product more detectable under X-ray, the current study evaluates the end-points in a total of 25 patients. Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Device: ANEUFIX
ANEUFIX is administered through translumbar injection into the AAA using imaging techniques to guide the place of injection.
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Study Arms ICMJE | Experimental: Intervention
All patients enrolled are intended to be treated
Intervention: Device: ANEUFIX
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
25 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 2022 | ||||
Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Netherlands | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03918460 | ||||
Other Study ID Numbers ICMJE | TripleMed 002 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | TripleMed B.V. | ||||
Study Sponsor ICMJE | TripleMed B.V. | ||||
Collaborators ICMJE | Trium Clinical Consulting | ||||
Investigators ICMJE |
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PRS Account | TripleMed B.V. | ||||
Verification Date | June 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |