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

Not Applicable

Completed

• Conditions: Abdominal Aortic Aneurysm
• Interventions: Procedure: EVAR without coils embolization/ Coils embolization during EVAR

• Registration Number: NCT01878240
• Lead Sponsor: Centre Chirurgical Marie Lannelongue

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 Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-17
• Study First Submitted QC: 2013-06-12
• Study First Posted: 2013-06-14
• Primary Completion: 2017-04
• Status Verified: 2019-04
• Study Completion: 2019-05
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EVAR	EVAR without coils embolization/ Coils embolization during EVAR	Endovascular repair of an Abdominal Aortic Aneurysm
Coil embolization during EVAR	EVAR without coils embolization/ Coils embolization during EVAR	coil embolization during Endovascular repair

Primary Outcome Measures

Name	Time	Method
Evaluation at one month the presence or absence of endoleak type II in all patients for each group by Computer Tomography and Doppler.	1 month

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Hopital Henri Mondor - APHP; 🇫🇷 Creteil, Ile De France, France

Centre Chirurgical MarieLannelongue; 🇫🇷 Le Plessis Robinson, Ile De France, France

Institut Mutualiste Montsouris; 🇫🇷 Paris, Ile De France, France