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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Study Focuses on the Use of Covered Stents (Stent Grafts) for the Treatment of Dysfunctional Vascular Access of Hemodialysis Patients
• Intervention / Treatment: Device: Covered Stent placement

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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Panagiotis M Kitrou, MD, MSc, PhD, EBIR, FCIRSE; Phone Number: +306946686766; Email: panoskitrou@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Covered Stent Group; Patients with a dysfunctional hemodialysis vascular access undergoing treatment procedure using a covered stent (stent graft).	Device: Covered Stent placement; Covered stent placement for the treatment of dysfunctional vascular access of hemodialysis patients; Other Names: Stent placement; Stent Graft placement; Vascular Access intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness: Clinically assessed intervention-free period of the treated segment	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.	6 months
Safety: Procedural Complications	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	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Access Circuit Primary Patency	The interval of patency after an endovascular intervention until any repeat intervention of the access circuit.	12 months
Postintervention assisted primary patency	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	12 months
Anatomic success	Defined as the resumption of normal hemodialysis for a minimum of at least 1 session following percutaneous intervention.	12 months
Clinically assessed intervention-free period of the treated segment	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.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory analysis	for identification of independent predictors influencing primary outcome measures.	12 months

Collaborators and Investigators

• Sponsor: University Hospital of Patras

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): May 24, 2021
• Last Update Submitted That Met QC Criteria: May 20, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: dialysis; vascular access; arteriovenous graft; covered stent; arteriovenous fitula
• Other Study ID Numbers: UHPatras

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be collected from investigator sites and statistical analysis will be performed. Results will be presented to the investigators prior to publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes