Ignite Creation Date:
2024-05-06 @ 1:16 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01776450
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2019-07-24
First Post:
2013-01-21
Brief Title:
Compassionate Use of the Incraft AAA Stent Graft System
Sponsor:
Cordis Corporation
Organization:
Cordis Corporation
Study Overview
Official Title:
Compassionate Use of the Incraft AAA Stent Graft System
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2019-07
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:
To treat patients with abdominal aortic aneurysms requiring endovascular repair outside of the clinical protocol through compassionate use
Detailed Description:
In the US abdominal aortic aneurysms AAA are found in 4-8 of older men and 05-15 of older women resulting in 30000-40000 elective procedures and 1400 peri-operative deaths The most significant complication of AAA is an aneurysm sac rupture from which more than 15000 patients die annually and is the 15th leading cause of death in elderly between 60 to 85 years of age In Japan it is estimated that approximately 14000 endovascular aneurysm repair EVAR and open surgical repair cases were performed in the year 2010
Abdominal aortic aneurysms can be treated three ways 1 Medical management 2 Open surgical repair and 3 Endovascular aneurysm repair EVAR EVAR has emerged as an alternative treatment of AAA for most patients It is less invasive than open repair and carries lower rates of early mortality and morbidity It has also extended treatment options to patients who cannot undergo conventional surgical procedures due to a high operative risk As EVAR technology evolves it allows treatment of AAA with increasing complexity of the aortic neck and access vessels
The InCraft AAA Stent Graft System is designed for endovascular repair of infrarenal AAAs with complex aortic anatomies This stent-graft system utilizes nitinol stent and polyester graft technology in an ultra-low profile delivery system which assists the physician in deploying the device in a controlled consistent and precise manner within the aortic neck and iliac arteries By isolating the aneurysmal sac the system provides an alternative blood flow path to relieve pressure on the arterial vessel walls and minimize aneurysm growth and the potential for aneurysm sac rupture
Abdominal aortic aneurysms can be treated three ways 1 Medical management 2 Open surgical repair and 3 Endovascular aneurysm repair EVAR EVAR has emerged as an alternative treatment of AAA for most patients It is less invasive than open repair and carries lower rates of early mortality and morbidity It has also extended treatment options to patients who cannot undergo conventional surgical procedures due to a high operative risk As EVAR technology evolves it allows treatment of AAA with increasing complexity of the aortic neck and access vessels
The InCraft AAA Stent Graft System is designed for endovascular repair of infrarenal AAAs with complex aortic anatomies This stent-graft system utilizes nitinol stent and polyester graft technology in an ultra-low profile delivery system which assists the physician in deploying the device in a controlled consistent and precise manner within the aortic neck and iliac arteries By isolating the aneurysmal sac the system provides an alternative blood flow path to relieve pressure on the arterial vessel walls and minimize aneurysm growth and the potential for aneurysm sac rupture
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