NCT04897828

REtrospective Analysis on the Use of COvered Stents for the Treatment of the Dysfunctional Vascular Access

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: University Hospital of Patras · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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, patient's death). Terms and definitions of outcome measures are provided below. Study's 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, patient's death). If a scientific committee's approval is needed for the data collection, it is the center's 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).

Conditions

• Study Focuses on the Use of Covered Stents (Stent Grafts) for the Treatment of Dysfunctional Vascular Access of Hemodialysis Patients

Interventions

Type	Name	Description
DEVICE	Covered Stent placement	Covered stent placement for the treatment of dysfunctional vascular access of hemodialysis patients

Timeline

• Start date: 2021-06-01
• Primary completion: 2021-09-30
• Completion: 2021-12-31
• First posted: 2021-05-24
• Last updated: 2021-05-24

Regulatory

• FDA-regulated device study