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Sponsors and Collaborators: |
Rennes University Hospital Medtronic |
Information provided by: | Rennes University Hospital |
ClinicalTrials.gov Identifier: | NCT00372138 |
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 graft)is 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.
Condition | Intervention |
Abdominal Aortic Aneurysms |
Procedure: Reinjection of PRP and autologous thrombin in aneurysm sac |
MedlinePlus related topics: | Aneurysms |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Prevention of Endoleaks Using Autologous Platelet Gel During Endovascular Procedures on Unruptured Abdominal Aortic Aneurysms: Pilot Study |
Estimated Enrollment: | 15 |
Study Start Date: | September 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient eligible to endovascular treatment:
Exclusion Criteria:
Contact: Alain Cardon, MD | 33-2-9928-9568 | alain.cardon@chu-rennes.fr |
Contact: Bruno Laviolle, MD | 33-2-9928-9481 | bruno.laviolle@chu-rennes.fr |
France | |||||
Service de Chirurgie Vasculaire - Hôpital de Pontchaillou | Recruiting | ||||
Rennes, France, 35033 | |||||
Contact: Alain Cardon, MD 33-2-9928-9568 alain.cardon@chu-rennes.fr | |||||
Principal Investigator: Alain Cardon, MD | |||||
Sub-Investigator: Philippe Kergosien, MD | |||||
Sub-Investigator: Antoine Lucas, MD | |||||
Sub-Investigator: Cyril Kakon, MD |
Rennes University Hospital |
Medtronic |
Principal Investigator: | Alain Cardon, MD | CHU Rennes |
Study Chair: | Bruno Laviolle, MD | CHU Rennes |
Study ID Numbers: | AFSSAPS TC211, LOC/05-04, CIC0203/057 |
First Received: | September 5, 2006 |
Last Updated: | June 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00372138 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
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