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

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Descriptive Information
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 Phase N/A
Study Type † Interventional
Study Design †
Primary Outcome Measure † 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 Measure † • Evaluation at 6, 12 and 24 months by CT and doppler: -The rate of type II endoleak
Condition † Abdominal Aortic Aneurysm
Intervention † ProcedureEVAR without coils embolization/ Coils embolization during EVAR
Study Arms / Comparison Groups EVAR Endovascular repair of an Abdominal Aortic Aneurysm Coil embolization during EVAR coil embolization during Endovascular repair
Publications *

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

Recruitment Information
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 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, MD Vascular Surgeon, + 33(0) 1 40 94 85 76, d.fabre@ccml.fr
Location Countries † France
Administrative Information
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
Investigators † Principal Investigator: Dominique FABRE, Vascular surgeon, Centre Chirurgical Marie Lannelongue
Information Provided By
Verification Date May 2017
First Received Date † May 17, 2013
Last Updated Date May 21, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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