Ignite Creation Date:
2024-05-06 @ 12:13 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03701243
Status:
UNKNOWN
Last Update Posted:
2019-09-25
First Post:
2018-10-07
Brief Title:
Compare Elbow mNT-BBAVF With Wrist RCAVF for Hemodialysis Access
Sponsor:
Shanghai 10th Peoples Hospital
Organization:
Shanghai 10th Peoples Hospital
Study Overview
Official Title:
A Multicenter Open-labelled Randomized Study to Compare the Primary Patency and Safety of Elbow Modified Non-transposed Brachiobasilic Arteriovenous Fistula With Wrist Radiocephalic Arteriovenous Fistula in Hemodialysis Patients
Status:
UNKNOWN
Status Verified Date:
2019-09
Last Known Status:
NOT_YET_RECRUITING
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:
Investigator plan to conduct a multicenter open-labelled randomized study to compare the primary patency and safety of elbow mNT-BBAVF and wrist RCAVF in hemodialysis patients
Detailed Description:
Although wrist radiocephalic arteriovenous fistula RCAVF has been recommended as first preferred fistula in many clinical practical guidelines for vascular access there are no randomized controlled trials RCTs comparing the recommended anatomic order of distal-to-proximal access construction up to now A modified non-transposed brachiobasilic arteriovenous fistula mNT-BBAVF that has a long length of suitable superficial vein for cannulation and a sufficient blood flow for effective dialysis has been introduced by investigator for several years In addition mNT-BBAVF has good primary patency and a low risk of complication and leave opportunities for further procedures in the event of failure Investigator plan to conduct a multicenter open-labelled randomized study to compare the primary patency and safety of elbow mNT-BBAVF and wrist RCAVF in hemodialysis patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None