Arteriovenous Graft ThrombosisNCT05071872
PMCF of Rotarex®S & Aspirex®S Catheters in Treating Thrombotic Occlusion of Arteriovenous Graft
An observational study of Arteriovenous Graft Thrombosis, run by Straub Medical AG at 1 site in Czechia.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Graft Thrombosis
- What is being tested?
- Atherectomy/Thrombectomy
- Type of treatment
- Medical device
- How many people
- 127 participants
- Where
- 1 siteCzechia
- Study dates
- 6 Oct 2021to 8 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute thrombotic occlusion of arteriovenous graft for dialysis access (Artificial Bypass) treated with either Rotarex®S Catheter nor Aspirex®S Catheter
Who may be able to join
- Female or male subject with a minimum age of 18 years
- Treatment performed between 2013 and 2020
- Occlusion in arteriovenous graft
- For the Rotarex®S group: use of Rotarex®S Catheter
- For the Aspirex®S group: use of Aspirex®S Catheter
Who cannot join
- 1. Subjects not appropriate for this study according to the opinion of the principal investigator
Trial locations and contacts
1 site in 1 country.
About this study
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)
Retrospective Post-Market Clinical Follow Up of Rotarex®S \& Aspirex®S Catheters in treating thrombotic occlusion of Arteriovenous Graft for dialysis access (Artificial Bypass)
Read the 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.
- Conditions
- Arteriovenous Graft Thrombosis
- Being tested
- Atherectomy/Thrombectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atherectomy/ThrombectomyDevice
Percutaneous transluminal removal of thrombotic occlusion in arteriovenous graft
| Study group | Role | What they receive |
|---|---|---|
| Rotarex®S | Treatment performed with Rotarex®S Receives: Device: Atherectomy/Thrombectomy | |
| Aspirex®S | Treatment performed with Aspirex®S Receives: Device: Atherectomy/Thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
defined as removal of thrombotic occlusion in AV-G with Rotarex®S or Aspirex®S Catheter
Measured: Day 1
Secondary outcomes (7)
Procedural success
defined as restoration of blood flow in AV-G following Rotarex®S or Aspirex®S Catheter ± adjunctive treatment
Measured: Day 1
Successful use of AV-Graft as dialysis access
Successful use of AV-Graft as dialysis access post-procedure on at least two occasions
Measured: Up to 14 days
Primary and Secondary Patency
defined as ability to perform dialysis at 10 days, 1 month, 3 months and 6 months
Measured: 10 days, 1, 3 and 6 months
(SAEs) Serious Adverse events Rate
SAEs as defined per ISO 14155
Measured: 6 months
Procedure-related Adverse events Rate
Procedure-related AEs as defined per ISO 14155
Measured: 6 months
(ADEs) Adverse device effects Rate
Adverse device effects (ADEs) as defined per ISO 14155
Measured: 6 months
(SADEs) Serious Adverse Device Effects Rate
(SADEs) Serious Adverse Device Effects as defined per ISO 14155
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start6 Oct 2021
- Primary completion8 Jun 2022
- Study completion8 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous Graft ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Straub Medical AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samuel Heller, M.D., Principal investigator, Angiocentrum Příbram
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071872
- Sponsor's protocol ID
- PMCF-Arteriovenous Graft
- Status last verified
- Dec 2021
- First submitted
- 27 Sep 2021
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05071872
- Acronym / sponsor ID
- PMCF-Arteriovenous Graft
- Conditions
- Arteriovenous Graft Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Straub Medical AGIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective Post-Market Clinical Follow Up of Rotarex®S \& Aspirex®S Catheters in treating thrombotic occlusion of Arteriovenous Graft for dialysis access (Artificial Bypass)
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotarex®S | – | Device: Atherectomy/ThrombectomyTreatment performed with Rotarex®S |
| Aspirex®S | – | Device: Atherectomy/ThrombectomyTreatment performed with Aspirex®S |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute thrombotic occlusion of arteriovenous graft for dialysis access (Artificial Bypass) treated with either Rotarex®S Catheter nor Aspirex®S Catheter
Key inclusion criteria (5 listed)
- Female or male subject with a minimum age of 18 years
- Treatment performed between 2013 and 2020
- Occlusion in arteriovenous graft
- For the Rotarex®S group: use of Rotarex®S Catheter
- For the Aspirex®S group: use of Aspirex®S Catheter
Key exclusion criteria (1 listed)
- 1. Subjects not appropriate for this study according to the opinion of the principal investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atherectomy/ThrombectomyPercutaneous transluminal removal of thrombotic occlusion in arteriovenous graft | Device | Aspirex®S, Rotarex®S |
Primary outcome
Technical success
Time frame: Day 1
defined as removal of thrombotic occlusion in AV-G with Rotarex®S or Aspirex®S Catheter
7 secondary outcomes
Procedural success
Time frame: Day 1
Successful use of AV-Graft as dialysis access
Time frame: Up to 14 days
Primary and Secondary Patency
Time frame: 10 days, 1, 3 and 6 months
(SAEs) Serious Adverse events Rate
Time frame: 6 months
Procedure-related Adverse events Rate
Time frame: 6 months
(ADEs) Adverse device effects Rate
Time frame: 6 months
(SADEs) Serious Adverse Device Effects Rate
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
Related trials for Arteriovenous Graft Thrombosis
RecruitingObservational study
Changes in Regional Ventilation-Perfusion Match Following Percutaneous Transluminal Angioplasty for Arteriovenous Graft Thrombosis
Arteriovenous Graft Thrombosis, End Stage Renal Disease on Dialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Heller, M.D. principal investigator
Angiocentrum Příbram
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arteriovenous Graft Thrombosis, run by Straub Medical AG at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.