Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04897828
Status:
UNKNOWN
Last Update Posted:
2021-05-24
First Post:
2021-05-19
Brief Title:
REtrospective Analysis on the Use of COvered Stents for the Treatment of the Dysfunctional Vascular Access
Sponsor:
University Hospital of Patras
Organization:
University Hospital of Patras
Study Overview
Official Title:
REtrospective Analysis on the Use of COvered Stents for the Treatment of the Dysfunctional Vascular Access
Status:
UNKNOWN
Status Verified Date:
2021-05
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:
RECOVA
Brief Summary:
This will be a multi-center multi-national investigator-initiated and lead retrospective analysis assessing the safety and the clinical use of covered stents for the treatment of dysfunctional vascular access
Detailed Description:
This will be a multi-center multi-national investigator initiated and lead retrospective analysis assessing the safety and the clinical use of covered stents for the treatment of the dysfunctional vascular access
There are no limitations on the type of covered stent use the reason or the length of the treatment area The only limitations are the one owed to covered stent diameter and that patients included in the study should be treated for only one treatment area
The criteria for inclusion the outcome measures and the variables that should be recorded are listed below
There is also no limitation if data has been previously published in another study however data as part of an ongoing study or of a study in press cannot be submitted
Due to previous experience from similar studies it is known that it will be difficult to have data available for all re-interventions Thus study will focus on primary patency and safety Nevertheless centers should provide data regarding circuit survival thrombosis abandonment surgical revision patients death Terms and definitions of outcome measures are provided below
Studys final follow-up date is March 31st 2021 Patient should have a minimum follow-up of 6 months to be included in the study at that timepoint unless circuit is no longer in use thrombosis abandonment surgical revision patients death
If a scientific committees approval is needed for the data collection it is the centers responsibility to acquire it If this is waived due to the nature of the study this should also be stated
A large number of data will be recorded so hopefully a lot of meaningful evidence will come up from this effort As seen below situations out of those allowed in the instructions for use for covered stents are included ruptures pseudoaneurysms cannulation zone placement etc
There are no limitations on the type of covered stent use the reason or the length of the treatment area The only limitations are the one owed to covered stent diameter and that patients included in the study should be treated for only one treatment area
The criteria for inclusion the outcome measures and the variables that should be recorded are listed below
There is also no limitation if data has been previously published in another study however data as part of an ongoing study or of a study in press cannot be submitted
Due to previous experience from similar studies it is known that it will be difficult to have data available for all re-interventions Thus study will focus on primary patency and safety Nevertheless centers should provide data regarding circuit survival thrombosis abandonment surgical revision patients death Terms and definitions of outcome measures are provided below
Studys final follow-up date is March 31st 2021 Patient should have a minimum follow-up of 6 months to be included in the study at that timepoint unless circuit is no longer in use thrombosis abandonment surgical revision patients death
If a scientific committees approval is needed for the data collection it is the centers responsibility to acquire it If this is waived due to the nature of the study this should also be stated
A large number of data will be recorded so hopefully a lot of meaningful evidence will come up from this effort As seen below situations out of those allowed in the instructions for use for covered stents are included ruptures pseudoaneurysms cannulation zone placement etc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None