PMCF of Rotarex®S & Aspirex®S Catheters in Treating Thrombotic Occlusion of Arteriovenous Graft

Straub Medical

Status: Completed

Conditions: Arteriovenous Graft Thrombosis

Treatments: Device: Atherectomy/Thrombectomy

Study type: Observational

Funder types: Industry

Identifiers

NCT05071872

PMCF-Arteriovenous Graft

Details and patient eligibility

About

Retrospective Post-Market Clinical Follow Up of Rotarex®S & Aspirex®S Catheters in treating thrombotic occlusion of Arteriovenous Graft for dialysis access (Artificial Bypass)

Full description

To evaluate the safety, technical performance, and clinical efficacy of the Rotarex®S & Aspirex®S Catheters as a stand-alone and adjunctive therapy for the treatment of acute thrombotic occlusion of arteriovenous graft for dialysis access (Artificial Bypass) in accordance with Rotarex®S & Aspirex®S Catheters intended use.

Enrollment: 127 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Female or male subject with a minimum age of 18 years
2. Treatment performed between 2013 and 2020
3. Occlusion in arteriovenous graft
4. For the Rotarex®S group: use of Rotarex®S Catheter
5. For the Aspirex®S group: use of Aspirex®S Catheter

Exclusion criteria

1. Subjects not appropriate for this study according to the opinion of the principal investigator

Trial design

127 participants in 2 patient groups

Rotarex®S

Description:

Treatment performed with Rotarex®S

Treatment:

Device: Atherectomy/Thrombectomy

Aspirex®S

Description:

Treatment performed with Aspirex®S

Treatment:

Device: Atherectomy/Thrombectomy