Abdominal Aortic Aneurysm Clinical Trial
— SCOPE1Official title:
Prevention of Type II Endoleaks During Endovascular Treatment of Abdominal Aortic Aneurysm: Endovascular Treatment Versus Combination With Coil Embolisation of the Aneurysmal Sac
Verified date | April 2019 |
Source | Centre Chirurgical Marie Lannelongue |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | May 2019 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | 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 |
Lead Sponsor | Collaborator |
---|---|
Centre Chirurgical Marie Lannelongue | Henri Mondor University Hospital, Institut Mutualiste Montsouris, Unité de Recherche Clinique du Centre chirurgical marie Lannelongue |
France,
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. — View 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 ane — View 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):93 — View 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 — View 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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | • Evaluation at 6, 12 and 24 months by CT and doppler: -The rate of type II endoleak | 6, 12 and 24 months | ||
Secondary | • Mortality and morbidity . | 1, 6, 12 and 24 months | ||
Secondary | • Number of additional procedures -endovascular -surgical | 1, 6, 12 and 24 months | ||
Secondary | • Complications of endovascular procedures away from the EVAR -Thrombosis of leg -Limb occlusion -Evolution of the aneurysmal neck | 1, 6, 12 and 24 months | ||
Secondary | • Monitoring of renal function (creatinine clearance). | 1, 6, 12 and 24 months | ||
Secondary | • Evaluation at 6, 12 and 24 months by CT and doppler: -Measurement of the maximum transverse aneurysm diameter | 6, 12 and 24 months | ||
Secondary | • Evaluation at 6, 12 and 24 months by CT and doppler: -volumetric measurement of the sac aneurysmal | 6, 12 and 24 months |
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