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

Arteriovenous Graft Thrombosis Clinical Trial

Official title:

Retrospective Post-Market Clinical Follow Up of Rotarex®S & Aspirex®S Catheters in Treating Thrombotic Occlusion of Arteriovenous Graft for Dialysis Access (Artificial Bypass)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05071872
• Other study ID #: PMCF-Arteriovenous Graft
• Status: Completed
• Start date: October 6, 2021
• Est. completion date: June 8, 2022

Study information

• Verified date: December 2021
• Source: Straub Medical AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: June 8, 2022
• Est. primary completion date: June 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Graft Thrombosis
• Thrombosis

Intervention

Device:
• Atherectomy/Thrombectomy
Percutaneous transluminal removal of thrombotic occlusion in arteriovenous graft

Locations

Country	Name	City	State
Czechia	Angiocentrum Príbram	Príbram

Sponsors (1)

Lead Sponsor	Collaborator
Straub Medical AG

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success	defined as removal of thrombotic occlusion in AV-G with Rotarex®S or Aspirex®S Catheter	Day 1
Secondary	Procedural success	defined as restoration of blood flow in AV-G following Rotarex®S or Aspirex®S Catheter ± adjunctive treatment	Day 1
Secondary	Successful use of AV-Graft as dialysis access	Successful use of AV-Graft as dialysis access post-procedure on at least two occasions	Up to 14 days
Secondary	Primary and Secondary Patency	defined as ability to perform dialysis at 10 days, 1 month, 3 months and 6 months	10 days, 1, 3 and 6 months
Secondary	(SAEs) Serious Adverse events Rate	SAEs as defined per ISO 14155	6 months
Secondary	Procedure-related Adverse events Rate	Procedure-related AEs as defined per ISO 14155	6 months
Secondary	(ADEs) Adverse device effects Rate	Adverse device effects (ADEs) as defined per ISO 14155	6 months
Secondary	(SADEs) Serious Adverse Device Effects Rate	(SADEs) Serious Adverse Device Effects as defined per ISO 14155	6 months