Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516653
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Post Market Study for VasQ an External Support Implant for Arteriovenous Fistula
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Postmarket Surveillance Prospective Multicenter Randomized Controlled Study Evaluating the Performance of VasQ for Its Intended Use
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
VasQ is an external support implant for arteriovenous fistulas created for dialysis access
This is a postmarket surveillance prospective multi-center randomized controlled open label trial enrolling 300 patients randomized into two study arms
Treatment arm End to side fistula supported with VasQ
Control Standard of care end to side fistula
This is a postmarket surveillance prospective multi-center randomized controlled open label trial enrolling 300 patients randomized into two study arms
Treatment arm End to side fistula supported with VasQ
Control Standard of care end to side fistula
Detailed Description:
Structure
This is a postmarket surveillance prospective multi-center randomized controlled open label trial enrolling 300 patients randomized into two study arms
Treatment arm End to side fistula supported with VasQ
Control Standard of care end to side fistula
Duration The primary endpoint is defined at 6 month post index procedure of fistula creation Patients will be further followed up to 12 months post index procedure
Main study question What is the magnitude of benefit of the VasQ device with regard to time to achieving a clinically functional AVF as compared to a comparable contemporary standard of care cohort
This is a postmarket surveillance prospective multi-center randomized controlled open label trial enrolling 300 patients randomized into two study arms
Treatment arm End to side fistula supported with VasQ
Control Standard of care end to side fistula
Duration The primary endpoint is defined at 6 month post index procedure of fistula creation Patients will be further followed up to 12 months post index procedure
Main study question What is the magnitude of benefit of the VasQ device with regard to time to achieving a clinically functional AVF as compared to a comparable contemporary standard of care cohort
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