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

NCT01878240 | Completed DMC

• 2 other identifiers: P12-37813003/2012A01258-35IDRCB 2012-A0125-35
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Abdominal Aortic Aneurysm

Keywords

Vascular surgery; Abdominal Aortic aneurysm; endovascular

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• • 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

• • 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

Study Arms (2)

EVAR

ACTIVE COMPARATOR

Endovascular repair of an Abdominal Aortic Aneurysm

Procedure: EVAR without coils embolization/ Coils embolization during EVAR

Coil embolization during EVAR

EXPERIMENTAL

coil embolization during Endovascular repair

Procedure: EVAR without coils embolization/ Coils embolization during EVAR

Interventions

EVAR without coils embolization/ Coils embolization during EVAR PROCEDURE

Also known as: Coil embolization during endovascular Aortic Abdominal Aneurysm repair

Coil embolization during EVAR; EVAR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Chirurgical Marie Lannelongue: lead
• Institut Mutualiste Montsouris: collaborator
• Henri Mondor University Hospital: collaborator
• Unité de Recherche Clinique du Centre chirurgical marie Lannelongue: collaborator

Study Sites (3)

Hopital Henri Mondor - APHP

Créteil, Île-de-France Region, 94000, France

Location

Centre Chirurgical MarieLannelongue

Le Plessis-Robinson, Île-de-France Region, 92350, France

Location

Institut Mutualiste Montsouris

Paris, Île-de-France Region, 75014, France

Location

Related Publications (6)

• 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.

  PMID: 23171095 RESULT

• 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.

  PMID: 22511690 RESULT

• 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.

  PMID: 23475697 RESULT

• 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.

  PMID: 23384494 RESULT

• 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.

  PMID: 21478500 RESULT

• 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.

  PMID: 33342658 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Dominique FABRE, Vascular surgeon

  Centre Chirurgical Marie Lannelongue

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2013
• First Posted: June 14, 2013
• Study Start: May 1, 2013
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2019
• Last Updated: January 22, 2020

Record last verified: 2019-04

Locations

FR (3)