Status:
TERMINATED
Prevention of Endoleaks Using Autologous Platelet Gel on Unruptured Abdominal Aortic Aneurysms
Lead Sponsor:
Rennes University Hospital
Collaborating Sponsors:
Medtronic
Conditions:
Abdominal Aortic Aneurysms
Eligibility:
All Genders
18+ years
Phase:
NA
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 conventi...
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, seem...
Eligibility Criteria
Inclusion
- Patient eligible to endovascular treatment:
- Any patient having an infrarenal or aortoiliac abdominal aortic aneurysm needing surgical treatment,
- With an infrarenal neck larger than 10 mm,
- No thrombi in the neck,
- Calcifications of the neck smaller than 30% of the circumference.
- The maximum diameter of the aneurysm must be at least 50 mm and/or an annual growth rate of more than 10 mm and/or if the aneurysm is symptomatic,
- With no major tortuosity of the two iliac axes with an aortoiliac angle greater than 80°,
- An external iliac diameter of at least 8 mm,
- An angle between the interrenal aorta and the neck of 0-45°.
- The patient must meet at least one of the operability criteria of the French Health Products Safety Agency (AFSSAPS)
Exclusion
- Patient with a hemostatic disorder, previously known or discovered during the preoperative lab work-up,
- Patient whose arterial anatomy is incompatible with the criteria form use of a TALENT type endovascular stent graft,
- Patient with an aneurysm whose rapid progression (risk of rupture) does not allow a radiological and scanographic assessments to be performed,
- Patient allergic to the iodized contrast media,
- Disease of the connective tissue (Marfan's Syndrome) or inflammatory aneurysm,
- Patient with an aneurysm that includes the orifice of both internal iliacs,
- Patient in whom it is essential to keep the inferior mesenteric artery permeable,
- Patient surgically converted after failure of an endovascular technique,
- Pregnant women,
- Failure of stent graft insertion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00372138
Start Date
September 1 2006
End Date
July 1 2008
Last Update
March 2 2012
Active Locations (1)
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1
Service de Chirurgie Vasculaire - Hôpital de Pontchaillou
Rennes, France, 35033