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

February 8, 2023 updated by: Straub Medical AG

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

127

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Příbram, Czechia
        • Angiocentrum Příbram

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Acute thrombotic occlusion of arteriovenous graft for dialysis access (Artificial Bypass) treated with either Rotarex®S Catheter nor Aspirex®S Catheter

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rotarex®S
Treatment performed with Rotarex®S
Device: Atherectomy/Thrombectomy
Percutaneous transluminal removal of thrombotic occlusion in arteriovenous graft
Aspirex®S
Treatment performed with Aspirex®S
Device: Atherectomy/Thrombectomy
Percutaneous transluminal removal of thrombotic occlusion in arteriovenous graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: Day 1
defined as removal of thrombotic occlusion in AV-G with Rotarex®S or Aspirex®S Catheter
Day 1

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Straub Medical AG

Investigators

  • Principal Investigator: Samuel Heller, M.D., Angiocentrum Příbram

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 6, 2021

Primary Completion (ACTUAL)

June 8, 2022

Study Completion (ACTUAL)

June 8, 2022

Study Registration Dates

First Submitted

September 27, 2021

First Submitted That Met QC Criteria

September 27, 2021

First Posted (ACTUAL)

October 8, 2021

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMCF-Arteriovenous Graft

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arteriovenous Graft Thrombosis

Clinical Trials on Atherectomy/Thrombectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe