ANEUFIX for Endoleaks Type II (ACP-T5)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02487290|
Recruitment Status : Active, not recruiting
First Posted : July 1, 2015
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Aortic Aneurysm||Device: Aneufix ACP-T5||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a feasibility study, where initially 5 patients are to be treated.|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Feasibility Study of Treatment Type II Endoleaks With ACP-T5: a Novel Approach.|
|Actual Study Start Date :||February 26, 2018|
|Actual Primary Completion Date :||February 1, 2019|
|Estimated Study Completion Date :||December 2020|
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 Name: ANEUFIX
- 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. [ Time Frame: 24h ]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.
- Clinical succes rate. [ Time Frame: 6 and 12 months ]The clinical succes rate is defined as the absence of aneurysm sac growth after the procedure of ACP-T5 injection.
- Safety aspects I : intra-operative complication rate. [ Time Frame: All complications observed during the ACP-T5 injection procedure are documented. ]Intra-operative occurrence of complications.
- Safety aspects II: Peri-operative complication rate. [ Time Frame: 1 month ]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.
- Safety aspects III : Mid- and long-term complication rate. [ Time Frame: 1-12 months ]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.
- Aneurysm sac rupture. [ Time Frame: 12 months ]The aneurysm sac rupture rate is assessed over a period of 12 months.
- Survival. [ Time Frame: 24 months. ]The survival rate throughout the study and up to 24 months is assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02487290
|Medisch Centrum Westeinde|
|Den Haag, Netherlands, 2512|
|Haarlem, Netherlands, 2035 RC|
|Principal Investigator:||Daniel Eefting, Dr||Medisch Centrum Westeinde Den Haag|
|Principal Investigator:||Erik Vermeulen, Dr||Spaarne Gasthuis Haarlem|