Trials / Completed
CompletedNCT02487290
ANEUFIX for Endoleaks Type II
Feasibility Study of Treatment Type II Endoleaks With ACP-T5: a Novel Approach.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- TripleMed B.V. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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'.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-02-26
- Primary completion
- 2019-02-01
- Completion
- 2020-12-15
- First posted
- 2015-07-01
- Last updated
- 2021-02-21
Locations
2 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT02487290. Inclusion in this directory is not an endorsement.