Ignite Creation Date:
2024-05-05 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 9:44 AM
Study NCT ID:
NCT00612924
Status:
COMPLETED
Last Update Posted:
2017-10-16
First Post:
2008-01-22
Brief Title:
The Vascutek AnacondaTM Stent Graft System Phase II IDE Study
Sponsor:
Terumo CVS
Organization:
Terumo CVS
Study Overview
Official Title:
The Anaconda Endovascular Graft US FDA Phase II Clinical Study
Status:
COMPLETED
Status Verified Date:
2017-10
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:
None
Brief Summary:
The Phase I safety study is now complete FDA approval has been granted to proceed to Phase II The primary objectives of the Phase II study is to assess the safety and effectiveness of the Anaconda Stent Graft System in subjects presenting with abdominal aortic aneurysm AAA The secondary objectives of this study are to assess additional clinical outcomes measurements associated with treatment of AAA using the Anaconda Stent Graft System
Detailed Description:
Abdominal aortic aneurysms afflict a large number of patients in the United States and world-wide The treatment of this disorder is based upon the concept of aneurysm repair prior to the presentation of symptoms or rupture Thus aneurysm repair can be viewed as a prophylactic procedure embarked upon to prevent the disastrous complications of a ruptured aneurysm The decision to treat an aneurysm electively is based upon a risk to benefit ratio Treatment options include medical management of co-morbidities hypertension pulmonary disease etc with observation of the aneurysm open surgical aneurysm repair through a transabdominal or retroperitoneal approach and endovascular aneurysm repair The decision to intervene is based upon physician judgment Once the decision to intervene is made the mode of the intervention must be chosen Although open surgical repair is more invasive and has been noted to have a higher morbidity and mortality12 than most endovascular reports few argue with the effectiveness of the procedure To date open surgical repair remains the gold standard of care for the aneurysm patient Endovascular repair has several beneficial characteristics in comparison to an open surgical approach They include the potential for decreased need for blood transfusions shorter intensive care unit and total hospital stays the lack of endotracheal intubation to name a few However the procedure requires adequate imaging prior to graft placement and during the follow-up period in addition to the availability of a trained team to ensure proper device placement
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 |
|---|---|---|---|
| G030036 | OTHER | FDA G030036 | None |