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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prevention of Type II Endoleaks During Endovascular Treatment of Abdominal Aortic Aneurysm: Endovascular Treatment Versus Combination With Coil Embolisation of the Aneurys

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

Detailed Summary:

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.


Sponsor: Centre Chirurgical Marie Lannelongue

Current 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. [ Time Frame: 1 month ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • • Evaluation at 6, 12 and 24 months by CT and doppler: -The rate of type II endoleak [ Time Frame: 6, 12 and 24 months ]
  • • Mortality and morbidity . [ Time Frame: 1, 6, 12 and 24 months ]
  • • Number of additional procedures -endovascular -surgical [ Time Frame: 1, 6, 12 and 24 months ]
  • • Complications of endovascular procedures away from the EVAR -Thrombosis of leg -Limb occlusion -Evolution of the aneurysmal neck [ Time Frame: 1, 6, 12 and 24 months ]
  • • Monitoring of renal function (creatinine clearance). [ Time Frame: 1, 6, 12 and 24 months ]
  • • Evaluation at 6, 12 and 24 months by CT and doppler: -Measurement of the maximum transverse aneurysm diameter [ Time Frame: 6, 12 and 24 months ]
  • • Evaluation at 6, 12 and 24 months by CT and doppler: -volumetric measurement of the sac aneurysmal [ Time Frame: 6, 12 and 24 months ]


Original Secondary Outcome: Same as current

Information By: Centre Chirurgical Marie Lannelongue

Dates:
Date Received: May 17, 2013
Date Started: May 2013
Date Completion: May 2018
Last Updated: March 25, 2016
Last Verified: March 2016