ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Prevention of Endoleaks Using Autologous Platelet Gel on Unruptured Abdominal Aortic Aneurysms

This study is currently recruiting participants.
Verified by Rennes University Hospital, June 2007

Sponsors and Collaborators: Rennes University Hospital
Medtronic
Information provided by: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT00372138
  Purpose

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   

U.S. FDA Resources

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

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Safety of the perioperative procedure for injecting PRP + autologous thrombin assessed by distal embolism, colic necrosis, aneurysm rupture. [ Time Frame: perioperative ]

Secondary Outcome Measures:
  • Description of the perioperative surgical technique for injecting PRP + autologous thrombin [ Time Frame: perioperative ]
  • Rate of occurrence of endoleaks at 1 month and types of endoleaks, [ Time Frame: 1 month ]
  • Time to onset of endoleaks, [ Time Frame: 1 month ]
  • Rate of complications related to the endovascular procedure. [ Time Frame: 1 month ]

Estimated Enrollment:   15
Study Start Date:   September 2006

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372138

Contacts
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    

Locations
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            

Sponsors and Collaborators
Rennes University Hospital
Medtronic

Investigators
Principal Investigator:     Alain Cardon, MD     CHU Rennes    
Study Chair:     Bruno Laviolle, MD     CHU Rennes    
  More Information


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

Keywords provided by Rennes University Hospital:
Abdominal aortic aneurysms  
Endoleaks  
Prevention  

Study placed in the following topic categories:
Thrombin
Aortic Diseases
Aneurysm
Aortic Aneurysm, Abdominal
Abdominal aortic aneurysm
Vascular Diseases
Aortic Aneurysm

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 16, 2008




Links to all studies - primarily for crawlers