EVAR without coils embolization/ Coils embolization during EVAR
ProcedureOther names: Coil embolization during endovascular Aortic Abdominal Aneurysm repair
NCT Number: NCT01878240
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Hopital Henri Mondor - APHP, Créteil, Île-de-France Region, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Coil embolization during endovascular Aortic Abdominal Aneurysm repair
Time frame: 1 month
Time frame: 6, 12 and 24 months
Time frame: 1, 6, 12 and 24 months
Time frame: 1, 6, 12 and 24 months
Time frame: 1, 6, 12 and 24 months
Time frame: 1, 6, 12 and 24 months
Time frame: 6, 12 and 24 months
Time frame: 6, 12 and 24 months
Centre Chirurgical Marie Lannelongue
Other
Acronym: SCOPE1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00488943
Abdominal Aortic Aneurysm, Aneurysm
San Francisco, California, United States
View Trial DetailsNCT02996396
Abdominal Aortic Aneurysm, Aneurysm
Augsburg, Germany
View Trial DetailsNCT06008613
Abdominal Aortic Aneurysm, Aneurysm
Cleveland, Ohio, United States
View Trial DetailsNCT06972095
Abdominal Aortic Aneurysm, Aneurysm
Arnhem, Netherlands
View Trial Details