Study Focuses on the Use of Covered Stents (Stent Grafts) for the Treatment of Dysfunctional Vascular Access of Hemodialysis PatientsRECOVANCT04897828
REtrospective Analysis on the Use of COvered Stents for the Treatment of the Dysfunctional Vascular Access
An observational study of Study Focuses on the Use of Covered Stents (Stent Grafts) for the Treatment of Dysfunctional Vascular Access of Hemodialysis Patients, run by University Hospital of Patras.
Trial summary
This will be a multi-center, multi-national, investigator-initiated and lead, retrospective analysis assessing the safety and the clinical use of covered stents for the treatment of dysfunctional vascular access. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Study Focuses on the Use of Covered Stents (Stent Grafts) for the Treatment of Dysfunctional Vascular Access of Hemodialysis Patients
- What is being tested?
- Covered Stent placement
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 31 Dec 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that received covered stent treatment for their dysfunctional hemodialysis vascular access at the different centers that will be included in the study
Who may be able to join
- Age >18 years and <80 years
- Patient on Dialysis with an Arteriovenous Fistula (AVF) or Graft (AVG)
- Clinical Signs of Vascular Access Dysfunction or presence of a Pseudoaneurysm or Intraprocedural Vessel Rupture
- Use of Covered Stent(s) for treatment
- Minimum follow-up: 6 months
Who cannot join
- >1 treatment areas included per procedure
- Covered Stent not available in the market any more
Trial locations and contacts
No sites are listed yet.
About this study
This will be a multi-center, multi-national, investigator-initiated and lead, retrospective analysis assessing the safety and the clinical use of covered stents for the treatment of dysfunctional vascular access.
Read the detailed description
This will be a multi-center, multi-national, investigator initiated and lead retrospective analysis assessing the safety and the clinical use of covered stents for the treatment of the dysfunctional vascular access.
There are no limitations on the type of covered stent use, the reason, or the length of the treatment area. The only limitations are the one owed to covered stent diameter and that patients included in the study should be treated for only one treatment area.
The criteria for inclusion, the outcome measures and the variables that should be recorded are listed below.
There is also no limitation if data has been previously published in another study, however data as part of an ongoing study, or of a study in press cannot be submitted.
Due to previous experience from similar studies it is known that it will be difficult to have data available for all re-interventions. Thus, study will focus on primary patency and safety. Nevertheless, centers should provide data regarding circuit survival (thrombosis, abandonment, surgical revision, patient's death). Terms and definitions of outcome measures are provided below.
Study's final follow-up date is March 31st, 2021. Patient should have a minimum follow-up of 6 months to be included in the study at that timepoint, unless circuit is no longer in use (thrombosis, abandonment, surgical revision, patient's death).
If a scientific committee's approval is needed for the data collection, it is the center's responsibility to acquire it. If this is waived due to the nature of the study, this should also be stated.
A large number of data will be recorded so hopefully, a lot of meaningful evidence will come up from this effort. As seen below, situations out of those allowed in the instructions for use for covered stents are included (ruptures, pseudoaneurysms, cannulation zone placement etc).
- Being tested
- Covered Stent placement
- Keywords
- covered stent, vascular access, dialysis, arteriovenous fitula, arteriovenous graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covered Stent placementDevice
Also called Stent placement, Stent Graft placement, Vascular Access intervention
Covered stent placement for the treatment of dysfunctional vascular access of hemodialysis patients
| Study group | Role | What they receive |
|---|---|---|
| Covered Stent Group | Patients with a dysfunctional hemodialysis vascular access undergoing treatment procedure using a covered stent (stent graft). Receives: Device: Covered Stent placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness: Clinically assessed intervention-free period of the treated segment
A dialysis access circuit with no need for clinically driven treatment area repeat intervention for symptom recurrence and angiographic verification of the presence of stenosis at the treatment area.
Measured: 6 months
Safety: Procedural Complications
Procedure-related Minor Complications No therapy, no consequence Nominal therapy, no consequence; includes overnight admission for observation only
Procedure-related Major Complications Require therapy, minor hospitalization (<48 hours). Require major therapy, unplanned increase in level of care, Prolonged hospitalization (>48 hours). Permanent adverse sequelae Death
Measured: 30 days
Secondary outcomes (4)
Access Circuit Primary Patency
The interval of patency after an endovascular intervention until any repeat intervention of the access circuit.
Measured: 12 months
Postintervention assisted primary patency
The interval of patency after the endovascular intervention until dialysis circuit thrombosis or a surgical intervention of the access circuit. Endovascular interventions in a previously treated lesion and a new arterial or venous outflow stenosis or occlusion (excluding access thrombosis) are compatible with assisted primary patency. Assisted primary patency ends with percutaneous thrombolysis/thrombectomy or surgical circuit thrombectomy
Measured: 12 months
Anatomic success
Defined as the resumption of normal hemodialysis for a minimum of at least 1 session following percutaneous intervention.
Measured: 12 months
Clinically assessed intervention-free period of the treated segment
A dialysis access circuit with no need for clinically driven treatment area repeat intervention for symptom recurrence and angiographic verification of the presence of stenosis at the treatment area.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Study Focuses on the Use of Covered Stents (Stent Grafts) for the Treatment of Dysfunctional Vascular Access of Hemodialysis PatientsStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panagiotis Kitrou, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897828
- Sponsor's protocol ID
- UHPatras
- Acronym
- RECOVA
- Status last verified
- May 2021
- First submitted
- 19 May 2021
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will be collected from investigator sites and statistical analysis will be performed. Results will be presented to the investigators prior to publication.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REtrospective Analysis on the Use of COvered Stents for the Treatment of the Dysfunctional Vascular Access
- ClinicalTrials.gov ID
- NCT04897828
- Acronym / sponsor ID
- RECOVA / UHPatras
- Keywords
- covered stent, vascular access, dialysis, arteriovenous fitula, arteriovenous graft
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital of PatrasUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 24 May 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.
This will be a multi-center, multi-national, investigator-initiated and lead, retrospective analysis assessing the safety and the clinical use of covered stents for the treatment of dysfunctional vascular access.
Detailed description
This will be a multi-center, multi-national, investigator initiated and lead retrospective analysis assessing the safety and the clinical use of covered stents for the treatment of the dysfunctional vascular access.
There are no limitations on the type of covered stent use, the reason, or the length of the treatment area. The only limitations are the one owed to covered stent diameter and that patients included in the study should be treated for only one treatment area.
The criteria for inclusion, the outcome measures and the variables that should be recorded are listed below.
There is also no limitation if data has been previously published in another study, however data as part of an ongoing study, or of a study in press cannot be submitted.
Due to previous experience from similar studies it is known that it will be difficult to have data available for all re-interventions. Thus, study will focus on primary patency and safety. Nevertheless, centers should provide data regarding circuit survival (thrombosis, abandonment, surgical revision, patient's death). Terms and definitions of outcome measures are provided below.
Study's final follow-up date is March 31st, 2021. Patient should have a minimum follow-up of 6 months to be included in the study at that timepoint, unless circuit is no longer in use (thrombosis, abandonment, surgical revision, patient's death).
If a scientific committee's approval is needed for the data collection, it is the center's responsibility to acquire it. If this is waived due to the nature of the study, this should also be stated.
A large number of data will be recorded so hopefully, a lot of meaningful evidence will come up from this effort. As seen below, situations out of those allowed in the instructions for use for covered stents are included (ruptures, pseudoaneurysms, cannulation zone placement etc).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Covered Stent Group | – | Device: Covered Stent placementPatients with a dysfunctional hemodialysis vascular access undergoing treatment procedure using a covered stent (stent graft). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that received covered stent treatment for their dysfunctional hemodialysis vascular access at the different centers that will be included in the study
Key inclusion criteria (5 listed)
- Age >18 years and <80 years
- Patient on Dialysis with an Arteriovenous Fistula (AVF) or Graft (AVG)
- Clinical Signs of Vascular Access Dysfunction or presence of a Pseudoaneurysm or Intraprocedural Vessel Rupture
- Use of Covered Stent(s) for treatment
- Minimum follow-up: 6 months
Key exclusion criteria (2 listed)
- >1 treatment areas included per procedure
- Covered Stent not available in the market any more
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 |
|---|---|---|
| Covered Stent placementAlso: Stent placement, Stent Graft placement, Vascular Access interventionCovered stent placement for the treatment of dysfunctional vascular access of hemodialysis patients | Device | Covered Stent Group |
Primary outcome
Effectiveness: Clinically assessed intervention-free period of the treated segment
Time frame: 6 months
A dialysis access circuit with no need for clinically driven treatment area repeat intervention for symptom recurrence and angiographic verification of the presence of stenosis at the treatment area.
Safety: Procedural Complications
Time frame: 30 days
Procedure-related Minor Complications No therapy, no consequence Nominal therapy, no consequence; includes overnight admission for observation only Procedure-related Major Complications Require therapy, minor hospitalization (<48 hours). Require major therapy, unplanned increase in level of care, Prolonged hospitalization (>48 hours). Permanent adverse sequelae Death
4 secondary outcomes
Access Circuit Primary Patency
Time frame: 12 months
Postintervention assisted primary patency
Time frame: 12 months
Anatomic success
Time frame: 12 months
Clinically assessed intervention-free period of the treated segment
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Individual participant dataSharing planned: No. IPD will be collected from investigator sites and statistical analysis will be performed. Results will be presented to the investigators prior to publication.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Study Focuses on the Use of Covered Stents (Stent Grafts) for the Treatment of Dysfunctional Vascular Access of Hemodialysis Patients, run by University Hospital of Patras.
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 2 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: status not confirmed, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Panagiotis M Kitrou, MD, MSc, PhD, EBIR, FCIRSE (+306946686766, panoskitrou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness: Clinically assessed intervention-free period of the treated segment (time frame: 6 months). The study lists 2 primary outcomes in all. 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 24 May 2021.