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

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

• Registration Number: NCT04897828
• Lead Sponsor: University Hospital of Patras

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).

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-05-20
• Last Update Submitted: 2021-05-20
• Study First Posted: 2021-05-24
• Last Update Posted: 2021-05-24
• Study Start: 2021-06-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Covered Stent Group	Covered Stent placement	Patients with a dysfunctional hemodialysis vascular access undergoing treatment procedure using a covered stent (stent graft).

Primary Outcome Measures

Name	Time	Method
Safety: Procedural Complications	30 days	Procedure-related Minor Complications No therapy, no consequence Nominal therapy, no consequence; includes overnight admission for observation only; Procedure-related Major Complications Require therapy, minor hospitalization (\<48 hours). Require major therapy, unplanned increase in level of care, Prolonged hospitalization (\>48 hours). Permanent adverse sequelae Death
Effectiveness: Clinically assessed intervention-free period of the treated segment	6 months	A dialysis access circuit with no need for clinically driven treatment area repeat intervention for symptom recurrence and angiographic verification of the presence of stenosis at the treatment area.

Secondary Outcome Measures

Name	Time	Method
Postintervention assisted primary patency	12 months	The interval of patency after the endovascular intervention until dialysis circuit thrombosis or a surgical intervention of the access circuit. Endovascular interventions in a previously treated lesion and a new arterial or venous outflow stenosis or occlusion (excluding access thrombosis) are compatible with assisted primary patency. Assisted primary patency ends with percutaneous thrombolysis/thrombectomy or surgical circuit thrombectomy
Access Circuit Primary Patency	12 months	The interval of patency after an endovascular intervention until any repeat intervention of the access circuit.
Anatomic success	12 months	Defined as the resumption of normal hemodialysis for a minimum of at least 1 session following percutaneous intervention.
Clinically assessed intervention-free period of the treated segment	12 months	A dialysis access circuit with no need for clinically driven treatment area repeat intervention for symptom recurrence and angiographic verification of the presence of stenosis at the treatment area.