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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05071872
Other study ID # PMCF-Arteriovenous Graft
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Terminated NCT04494035 - AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System N/A
Completed NCT03839264 - Optimal Screening Program in Detecting Stenosis and Predicting Thrombosis in Hemodialysis Graft