Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111176
Status:
COMPLETED
Last Update Posted:
2014-08-18
First Post:
2005-05-17
Brief Title:
STARZ-TX2 Clinical Study Study of Thoracic Aortic Aneurysm Repair With the Zenith TX2 Endovascular Graft
Sponsor:
Cook Group Incorporated
Organization:
Cook Group Incorporated
Study Overview
Official Title:
Study of Thoracic Aortic Aneurysm Repair With the Zenith TX2 Endovascular Graft
Status:
COMPLETED
Status Verified Date:
2014-08
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:
STARZ-TX2
Brief Summary:
The STARZ-TX2 trial Study of Thoracic Aortic Aneurysm Repair with the Zenith TX2R TAA Thoracic Aortic Aneurysm Endovascular Graft is a clinical trial approved by the United States Food and Drug Administration FDA to study the safety and effectiveness of the Zenith TX2 TAA Endovascular Graft in the treatment of thoracic aortic aneurysms ulcers
Detailed Description:
The STARZ-TX2 trial Study of Thoracic Aortic Aneurysm Repair with the Zenith TX2R TAA Endovascular Graft is a clinical trial approved by the FDA to study the safety and effectiveness of the Zenith TX2R TAA Endovascular Graft in the treatment of thoracic aortic aneurysms ulcers Instead of making a large incision in the chest the physician makes a small incision near the groin to insert and guide the graft into place in the aorta relieving pressure on the aneurysm and helping to reduce the risk of rupture
The Zenith TX2 TAA Endovascular Graft is a reinforced fabric tube that is sized to the length of the aorta that needs to be covered to seal off the aneurysm ulcer The graft is made of a polyester material like that used in open surgical repair Standard surgical suture is used to sew the graft material to a frame of self-expanding stainless steel stents which provide support The materials used in the Zenith TX2 system have a long history of use in medical implants
The Zenith TX2 TAA Endovascular Graft is a reinforced fabric tube that is sized to the length of the aorta that needs to be covered to seal off the aneurysm ulcer The graft is made of a polyester material like that used in open surgical repair Standard surgical suture is used to sew the graft material to a frame of self-expanding stainless steel stents which provide support The materials used in the Zenith TX2 system have a long history of use in medical implants
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 |
|---|---|---|---|
| 37010 | None | None | None |