Clinical trial NCT01878240: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Keywords: Vascular surgery
Abdominal Aortic aneurysm
endovascular
Lead sponsor: Centre Chirurgical Marie Lannelongue
Sponsor class: OTHER
Collaborators: name: Institut Mutualiste Montsouris
name: Henri Mondor University Hospital
name: Unité de Recherche Clinique du Centre chirurgical marie Lannelongue
First posted: 2013-06-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Evaluation at one month the presence or absence of endoleak type II in all patients for each group by Computer Tomography and Doppler.
timeFrame: 1 month
Secondary outcomes:
measure: • Evaluation at 6, 12 and 24 months by CT and doppler: -The rate of type II endoleak
timeFrame: 6, 12 and 24 months
measure: • Mortality and morbidity .
timeFrame: 1, 6, 12 and 24 months
measure: • Number of additional procedures -endovascular -surgical
timeFrame: 1, 6, 12 and 24 months
measure: • Complications of endovascular procedures away from the EVAR -Thrombosis of leg -Limb occlusion -Evolution of the aneurysmal neck
timeFrame: 1, 6, 12 and 24 months
measure: • Monitoring of renal function (creatinine clearance).
timeFrame: 1, 6, 12 and 24 months
measure: • Evaluation at 6, 12 and 24 months by CT and doppler: -Measurement of the maximum transverse aneurysm diameter
timeFrame: 6, 12 and 24 months
measure: • Evaluation at 6, 12 and 24 months by CT and doppler: -volumetric measurement of the sac aneurysmal
timeFrame: 6, 12 and 24 months
Other outcomes:
Locations:
city: Creteil
country: France
facility: Hopital Henri Mondor - APHP
state: Ile De France
city: Le Plessis Robinson
country: France
facility: Centre Chirurgical MarieLannelongue
state: Ile De France
city: Paris
country: France
facility: Institut Mutualiste Montsouris
state: Ile De France
Study officials:
affiliation: Centre Chirurgical Marie Lannelongue
name: Dominique FABRE, Vascular surgeon
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lederle FA, Freischlag JA, Kyriakides TC, Matsumura JS, Padberg FT Jr, Kohler TR, Kougias P, Jean-Claude JM, Cikrit DF, Swanson KM; OVER Veterans Affairs Cooperative Study Group. Long-term comparison of endovascular and open repair of abdominal aortic aneurysm. N Engl J Med. 2012 Nov 22;367(21):1988-97. doi: 10.1056/NEJMoa1207481.
citation: Jackson RS, Chang DC, Freischlag JA. Comparison of long-term survival after open vs endovascular repair of intact abdominal aortic aneurysm among Medicare beneficiaries. JAMA. 2012 Apr 18;307(15):1621-8. doi: 10.1001/jama.2012.453.
citation: Stather PW, Sidloff D, Dattani N, Choke E, Bown MJ, Sayers RD. Systematic review and meta-analysis of the early and late outcomes of open and endovascular repair of abdominal aortic aneurysm. Br J Surg. 2013 Jun;100(7):863-72. doi: 10.1002/bjs.9101. Epub 2013 Mar 8.
citation: Piazza M, Frigatti P, Scrivere P, Bonvini S, Noventa F, Ricotta JJ 2nd, Grego F, Antonello M. Role of aneurysm sac embolization during endovascular aneurysm repair in the prevention of type II endoleak-related complications. J Vasc Surg. 2013 Apr;57(4):934-41. doi: 10.1016/j.jvs.2012.10.078. Epub 2013 Feb 4.
citation: Schanzer A, Greenberg RK, Hevelone N, Robinson WP, Eslami MH, Goldberg RJ, Messina L. Predictors of abdominal aortic aneurysm sac enlargement after endovascular repair. Circulation. 2011 Jun 21;123(24):2848-55. doi: 10.1161/CIRCULATIONAHA.110.014902. Epub 2011 Apr 10.
citation: Fabre D, Mougin J, Mitilian D, Cochennec F, Garcia Alonso C, Becquemin JP, Desgranges P, Allaire E, Hamdi S, Brenot P, Bourkaib R, Haulon S. Prospective, Randomised Two Centre Trial of Endovascular Repair of Abdominal Aortic Aneurysm With or Without Sac Embolisation. Eur J Vasc Endovasc Surg. 2021 Feb;61(2):201-209. doi: 10.1016/j.ejvs.2020.11.028. Epub 2020 Dec 17.