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

Brief Title

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

Official Title

Prevention of Endoleaks Using Autologous Platelet Gel During Endovascular Procedures on Unruptured Abdominal Aortic Aneurysms: Pilot Study

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.
    

Study Type

Interventional

Primary Outcome

Safety of the perioperative procedure for injecting PRP + autologous thrombin assessed by distal embolism, colic necrosis, aneurysm rupture.

Secondary Outcome

 Description of the perioperative surgical technique for injecting PRP + autologous thrombin

Condition

Abdominal Aortic Aneurysms

Intervention

PRP + autologous thrombin

Study Arms / Comparison Groups

 PRP + autologous thrombin

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Procedure

Estimated Enrollment

20

Start Date

September 2006

Completion Date

July 2008

Primary Completion Date

October 2007

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Alain Cardon, MD, , 

Location Countries

France

Location Countries

France

NCT ID

NCT00372138

Organization ID

AFSSAPS TC211

Secondary IDs

LOC/05-04

Responsible Party

Sponsor

Study Sponsor

Rennes University Hospital

Collaborators

 Medtronic

Study Sponsor

Alain Cardon, MD, Principal Investigator, CHU Rennes

Verification Date

March 2012