Ignite Creation Date:
2024-05-05 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 9:50 AM
Study NCT ID:
NCT00695253
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2007-12-28
Brief Title:
Physician-Sponsored IDE for Talent Endoluminal Spring Graft System in Patients With Abdominal Aortic Aneurysms AAA
Sponsor:
Rodney A White MD
Organization:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Study Overview
Official Title:
Physician-Sponsored IDE for Talent Endoluminal Spring Graft System in Patients With AAA
Status:
COMPLETED
Status Verified Date:
2023-02
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 purpose of this study is to evaluate the safety and effectiveness of the Talent Endoluminal Spring Graft System an investigational device to treat abdominal aortic aneurysms AAA The treatment population will include patients with an abdominal aortic aneurysm who meet the inclusionexclusion criteria All patients in the treatment population will undergo post-procedure follow-up evaluations at one 1 six 6 and 12 months and annually thereafter up to five 5 years post-procedure
Detailed Description:
Endovascular aneurysm repair EVAR offers certain advantages as compared to surgical repair of an abdominal aortic aneurysm Known benefits associated with EVAR as described in scientific literature include minimally invasive procedure shorter ICU and hospital stay reduced blood loss more rapid recovery and reduced need for general anesthesia Potential benefits that may be associated with use of the Talent device include reduced occurrence of endoleaks therefore reduced subsequent re-interventions The riskscomplications known to occur to all patients undergoing AAA repair may include anesthetic complications eg aspiration aneurysm enlargement rupture perforation or dissection bleeding arterial or venous thrombosis andor pseudoaneurysm arteriovenous fistula hematoma or coagulopathy bowel complications cardiac complications eg arrhythmia myocardial infarction congestive heart failure hypotension hypertension embolization micro and macro with transient or permanent ischemia or infarction genitourinary complications infection neurologic complications occlusion of device or native vessel pulmonaryrespiratory complications and renal complications
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