Ignite Creation Date:
2024-05-06 @ 1:41 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01878240
Status:
COMPLETED
Last Update Posted:
2020-01-22
First Post:
2013-05-17
Brief Title:
Prevention of Type II Endoleaks During Endovascular Treatment of Abdominal Aortic Aneurysm Endovascular Treatment Versus Combination With Coil Embolisation of the Aneurysmal Sac
Sponsor:
Centre Chirurgical Marie Lannelongue
Organization:
Centre Chirurgical Marie Lannelongue
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCOPE1
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IDRCB 2012-A0125-35 | OTHER | P12-37813003 | None |