Clinical trial NCT04897828: REtrospective Analysis on the Use of COvered Stents for the Treatment of the Dysfunctional Vascular Access
Official title: REtrospective Analysis on the Use of COvered Stents for the Treatment of the Dysfunctional Vascular Access
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Study Focuses on the Use of Covered Stents (Stent Grafts) for the Treatment of Dysfunctional Vascular Access of Hemodialysis Patients
Keywords: covered stent
vascular access
dialysis
arteriovenous fitula
arteriovenous graft
Lead sponsor: University Hospital of Patras
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that received covered stent treatment for their dysfunctional hemodialysis vascular access at the different centers that will be included in the study

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, 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).

Eligibility criteria: Inclusion Criteria:

* Age \>18 years and \<80 years
* Patient on Dialysis with an Arteriovenous Fistula (AVF) or Graft (AVG)
* Clinical Signs of Vascular Access Dysfunction or presence of a Pseudoaneurysm or Intraprocedural Vessel Rupture
* Use of Covered Stent(s) for treatment
* Minimum follow-up: 6 months

Exclusion Criteria:

* \>1 treatment areas included per procedure
* Covered Stent not available in the market any more

Primary outcomes:
measure: Effectiveness: Clinically assessed intervention-free period of the treated segment
timeFrame: 6 months
measure: Safety: Procedural Complications
timeFrame: 30 days
Secondary outcomes:
measure: Access Circuit Primary Patency
timeFrame: 12 months
measure: Postintervention assisted primary patency
timeFrame: 12 months
measure: Anatomic success
timeFrame: 12 months
measure: Clinically assessed intervention-free period of the treated segment
timeFrame: 12 months
Other outcomes:
measure: Exploratory analysis
timeFrame: 12 months
Locations:
Study officials:
References: