Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372138
Status:
TERMINATED
Last Update Posted:
2012-03-02
First Post:
2006-09-05
Brief Title:
Prevention of Endoleaks Using Autologous Platelet Gel on Unruptured Abdominal Aortic Aneurysms
Sponsor:
Rennes University Hospital
Organization:
Rennes University Hospital
Study Overview
Official Title:
Prevention of Endoleaks Using Autologous Platelet Gel During Endovascular Procedures on Unruptured Abdominal Aortic Aneurysms Pilot Study
Status:
TERMINATED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main risk of aortic aneurysms is rupture that leads to a high risk of death A preventive surgical treatment is thus needed In order to reduce the morbidity and mortality associated with conventional surgery an endovascular approach insertion of an endovascular stent graftis now widely favored The main problem of this procedure is the occurrence of endoleaks persistence of a communication between the aneurysm and the aorta A new approach is proposed to prevent these endoleaks The principle is to draw blood from the patient separate the blood from the platelets and reinject both platelet rich plasma PRP and autologous thrombin in order to form a platelet gel PRP autologous thrombin Before studying the efficacy of this technique its safety of use and feasibility must be evaluated
Detailed Description:
The main risk of aortic aneurysms is rupture Onset is usually sudden leading to the death of the patient in 80 to 90 of cases The elective treatment of abdominal aortic aneurysms therefore seems to be a priority In order to reduce the morbidity and mortality associated with conventional surgery an endovascular approach insertion of an endovascular stent graft using the endovascular aneurysm repair procedure is now widely favored The main problem during follow-up of patients wearing an endovascular stent graft is the occurrence of endoleaks resulting in retrograde filling of the aneurysm sac The ideal is to prevent these endoleaks either by new developments in endovascular stent grafts or by using adjuvant therapy during the procedure The principle is to draw blood from the patient separate the blood from the platelets and reinject it into two separate catheters one with platelet rich plasma PRP and the other with autologous thrombin in order to form a platelet gel PRP autologous thrombin Before studying the efficacy of this technique its safety of use and feasibility must be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIC0203057 | Other Identifier | Rennes University Hospital | None |
| LOC05-04 | OTHER | None | None |