Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00260728
Status:
TERMINATED
Last Update Posted:
2012-06-27
First Post:
2005-11-30
Brief Title:
The Boston Scientific ACCESS Trial
Sponsor:
Maquet Cardiovascular
Organization:
Maquet Cardiovascular
Study Overview
Official Title:
ACCESS Prospective Multi-center Trial of the Fusion Vascular Access Graft for Patients Who Require Early Vascular Access for Hemodialysis
Status:
TERMINATED
Status Verified Date:
2012-06
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:
ACCESS
Brief Summary:
The Boston Scientific ACCESS trial seeks to study the safety and to evaluate the success of the Fusion Vascular Access Graft for patients in need of early vascular access for hemodialysis
Detailed Description:
The Boston Scientific ACCESS trial seeks to study the safety and to evaluate the success of the Fusion Vascular Access Graft for patients in need of early vascular access for hemodialysis The primary objective is to demonstrate that secondary patency at 6 months for the Fusion Vascular Access Graft is not less than an objective performance criterion OPC minus a clinically relevant margin δ The OPC represents secondary patency at 6 months for the standard of care access grafts
The secondary safety endpoint is the occurrence of CEC-adjudicated device or procedure related adverse events through 24 months post implant procedure or through discharge for patients with unsuccessful device implantation Secondary efficacy endpoints includeprimary patency primary assisted patency ability to revise a failed graft early access capability time to hemostasis
Subjects will undergo a thorough medical assessment and physical examination pre-procedure and will be assessed peri-procedure Enrolled subjects with a device implanted will be evaluated at 1 6 12 18 and 24 months post implant procedure
The secondary safety endpoint is the occurrence of CEC-adjudicated device or procedure related adverse events through 24 months post implant procedure or through discharge for patients with unsuccessful device implantation Secondary efficacy endpoints includeprimary patency primary assisted patency ability to revise a failed graft early access capability time to hemostasis
Subjects will undergo a thorough medical assessment and physical examination pre-procedure and will be assessed peri-procedure Enrolled subjects with a device implanted will be evaluated at 1 6 12 18 and 24 months post implant procedure
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 |
|---|---|---|---|
| G050151 | None | None | None |