Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06297343
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-02-29
Brief Title:
Study of the Risk of Ischaemia Following the Creation of an Arteriovenous Fistula
Sponsor:
GCS Ramsay Santé pour lEnseignement et la Recherche
Organization:
GCS Ramsay Santé pour lEnseignement et la Recherche
Study Overview
Official Title:
Study of the Risk of Ischaemia Following the Creation of an Arteriovenous Fistula
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
MODIFVASC
Brief Summary:
The purpose of this study is to identify functional vascular changes and clinical factors correlated with the occurrence of short- or medium-term hand ischaemia after arteriovenous fistula creation
Detailed Description:
This is a non-interventional prospective non-randomised descriptive single-centre study with no comparator
The study population will be adult patients with chronic renal failure for whom an arteriovenous fistula has been planned
Patients requiring the creation of an arteriovenous fistula by the surgeons at Hôpital Privé des Peupliers will be seen beforehand in the usual pre-operative consultation during which the surgeon will explain the principle of the operation and the expected benefitsrisks On the day of surgery patients will undergo the surgical procedure to create an arteriovenous fistula and will be discharged the same day Patients will be reviewed during post-operative follow-up visits at 1 6 and 12 months as in standard practice All the data collected in the study were collected in routine medical practice
The study population will be adult patients with chronic renal failure for whom an arteriovenous fistula has been planned
Patients requiring the creation of an arteriovenous fistula by the surgeons at Hôpital Privé des Peupliers will be seen beforehand in the usual pre-operative consultation during which the surgeon will explain the principle of the operation and the expected benefitsrisks On the day of surgery patients will undergo the surgical procedure to create an arteriovenous fistula and will be discharged the same day Patients will be reviewed during post-operative follow-up visits at 1 6 and 12 months as in standard practice All the data collected in the study were collected in routine medical practice
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