Prevention of Endoleaks Using Autologous Platelet Gel on Unruptured Abdominal Aortic Aneurysms

NCT ID: NCT00372138

Last Updated: 2012-03-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2008-07-31

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 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.

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.

Conditions

Abdominal Aortic Aneurysms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PRP + autologous thrombin

simultaneous perioperative PRP and autologous thrombin in the aneurysm sac, during the endovascular treatment of unruptured abdominal aortic aneurysms

Group Type: EXPERIMENTAL

PRP + autologous thrombin

Intervention Type: PROCEDURE

simultaneous perioperative PRP and autologous thrombin in the aneurysm sac, during the endovascular treatment of unruptured abdominal aortic aneurysms

Interventions

PRP + autologous thrombin

simultaneous perioperative PRP and autologous thrombin in the aneurysm sac, during the endovascular treatment of unruptured abdominal aortic aneurysms

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alain Cardon, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Bruno Laviolle, MD

Role: STUDY_CHAIR

CHU Rennes

Locations

Service de Chirurgie Vasculaire - Hôpital de Pontchaillou

Rennes, , France

Countries

France

Other Identifiers

LOC/05-04

Identifier Type: OTHER

Identifier Source: secondary_id

CIC0203/057

Identifier Type: -

Identifier Source: secondary_id

AFSSAPS TC211

Identifier Type: -

Identifier Source: org_study_id