Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fakkel bvba | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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'.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Aneufix ACP-T5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel Eefting, Dr | Medisch Centrum Westeinde Den Haag | Principal Investigator |
| Erik Vermeulen, Dr | Spaarne Gasthuis, Haarlem | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaarne Gasthuisberg | Haarlem | 2035 RC | Netherlands | |||
| Medisch Centrum Westeinde |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37073926 | Derived | 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. |
Not provided
Not provided
There is currently no plan to share with other investigators then those participating in the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D057867 | Endoleak |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
This is a feasibility study, where initially 5 patients are to be treated.
Not provided
Not provided
Not provided
Not provided
|
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. |
| The Hague |
| 2512 |
| Netherlands |
| D001018 |
| Aortic Diseases |
| D019106 | Postoperative Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |