Prevention of Type II Endoleaks During Endovascular Treatment of Abdominal Aortic Aneurysm: Endovascular Treatment Versus Combination With Coil Embolisation of the Aneurysmal Sac

Brief Title

Prevention of Type II Endoleaks During Endovascular Treatment of Abdominal Aortic Aneurysm: Endovascular Treatment Versus Combination With Coil Embolisation of the Aneurysmal Sac

Official Title

Prevention of Type II Endoleaks During Endovascular Treatment of Abdominal Aortic Aneurysm: Endovascular Treatment Versus Combination With Coil Embolisation of the Aneurysmal Sac

Brief Summary

      Abdominal aortic aneurysms (AAAs) continue to be a leading cause of death in older age
      groups. In the 60-85 year-old population, AAA represents the 14th-leading cause of death.
      Federal funding through Medicare has been allocated for early detection using abdominal
      ultrasound screening programs. Despite these more aggressive screening programs and concerted
      efforts by surgeons for timely repair, the incidence of ruptured AAA has continued to
      increase.

      Endovascular aneurysm repair (EVAR) has been the most common type of repair since 2006.
      Multiple studies reflecting decreased perioperative morbidity and mortality over open repair
      make this an attractive option for patients. EVAR requires more intensive follow-up than
      standard open surgical repair, however. Secondary interventions are more common to maintain
      "seal" of the endograft within the aorta and subsequent exclusion of the aneurysmal
      component.

      The term endoleak is specific to EVAR, and describes the primary means by which endografts
      fail. Type I endoleaks occur because of inadequate graft seal proximally or distally,
      resulting in perigraft flow and aneurysm sac pressurization. Type II endoleaks occur when
      branch arteries arising from the aneurysmal aorta back-bleed into the aneurysm sac due to
      collateral flow. Type III endoleaks occur when flow persists between segments of a modular
      graft. Type IV endoleaks occur when flow persists through endograft material (graft
      porosity). Type V endoleaks have also been called "endotension", and occur when
      pressurization of the sac occurs in the absence of any demonstrable endoleak. Type I and Type
      III endoleaks are most concerning for rupture, although persistent Type II endoleaks can also
      lead to aneurysm rupture and premature death.

      The most common method of EVAR follow-up is computed tomographic angiography (CTA). These
      studies allow accurate measurement of aneurysm sac diameters and volumes. They also are
      highly sensitive and specific for endoleaks. Type II endoleaks are treated if they remain
      persistent and are present in the setting of aneurysm sac enlargement. Type I and III
      endoleaks are immediately treated when identified. Type IV endoleaks are rarely seen with
      current endograft technology.
    

Detailed Description

      Study Objectives:

      The purpose of the current study is to compare the level of endoleaks between group 1 and 2
      at 1, 6, 12 and 24 months.

      Study Design Prospective interventional study, multicenter, open, randomized trial comparing
      the type II endoleak level in patients who benefited the endovascular AAA repair (group 1:
      without coils) versus combination with coil embolization of the aneurysmal sac (group II:
      with coils).

      The choice of treatment is randomized.
    

Study Type

Interventional

Primary Outcome

Evaluation at one month the presence or absence of endoleak type II in all patients for each group by Computer Tomography and Doppler.

Secondary Outcome

 • Evaluation at 6, 12 and 24 months by CT and doppler: -The rate of type II endoleak

Condition

Abdominal Aortic Aneurysm

Intervention

EVAR without coils embolization/ Coils embolization during EVAR

Study Arms / Comparison Groups

 EVAR

Description:  Endovascular repair of an Abdominal Aortic Aneurysm

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

100

Start Date

May 2013

Completion Date

May 2019

Primary Completion Date

April 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Age > 18 years

          -  Carrying a sub-renal AAA with a diameter of at least 5 cm at a rate of growth or
             greater 1cm/an diameter (according to Haute Autorité de Santé (HAS) recommendations
             toE VAR treatment),

          -  Patients with high risk of type II endoleak (clouding of an aortic aneurysm sac by
             collateral branch), respondents with at least one of the following criteria on the
             scanner to be included:

               -  The presence of a pair of permeable lumbar arteries.

               -  The presence of a patent inferior mesenteric artery.

        Exclusion Criteria:

          -  Sub renal Collet <10 mm

          -  Angulated > 60 °

          -  No collateral arising from the aneurysmal sac

          -  Iliac aneurysms associated

          -  Ruptured AAA

          -  Pregnant Women

          -  Lack of consent

          -  Lack of social security
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Dominique FABRE, Vascular surgeon, , 

Location Countries

France

Location Countries

France

NCT ID

NCT01878240

Organization ID

P12-37813003/2012A01258-35

Secondary IDs

IDRCB 2012-A0125-35

Responsible Party

Sponsor

Study Sponsor

Centre Chirurgical Marie Lannelongue

Collaborators

 Institut Mutualiste Montsouris

Study Sponsor

Dominique FABRE, Vascular surgeon, Principal Investigator, Centre Chirurgical Marie Lannelongue

Verification Date

April 2019