Outflow StenosisPhase 2SHARENCT00642083
Stenting of Haemodialysis Acces Trial
A Phase 2 study testing Viabahn stent-graft in people with Outflow Stenosis, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
The purpose of this study is to demonstrate the efficacy of a PTFE covered stent-graft in the prevention of outflow re-stenosis in loop fistula in a prospective trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Outflow Stenosis
- What is being tested?
- Viabahn stent-graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Start not givento Aug 2011
- Phase
- Phase 2
- 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
Who may be able to join
- Patients of 18 years of age
- Patients have a life expectancy of at least 2 years
- Signed informed consent
- Recurrent stenosis at the venous anastomosis or in the draining vein of a loop arterio venous fistula, within 2 cm from the anastomosis.
Who cannot join
- Patient unsuitable for administration of contrast agent
- Pregnancy
- Dementia or altered mental status that would prohibit giving conscious informed consent
- Need for adjunctive major surgical or vascular procedures within one month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stenting of Haemodialysis Acces Re-stenosis Trial (SHARE Trial)
The purpose of this study is to demonstrate the efficacy of a PTFE covered stent-graft in the prevention of outflow re-stenosis in loop fistula in a prospective trial.
- Conditions
- Outflow Stenosis
- Being tested
- Viabahn stent-graft
- Keywords
- outflow stenosis, stentgraft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viabahn stent-graftDevice
The viabahn stent-graft is a combined ePTFE-Nitinol self-expanding stent-graft preloaded on a catheter-based delivery system. It was originally designed for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions with reference vessel diameters ranging from 4.8 to 7.5 mm. This device is also increasingly used for the exclusion of popliteal aneurysms. Its flexibility might make the device ideal for the treatment of recurrent outflow stenosis in AV loop-fistula.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | viabahn stent-graft Receives: Device: Viabahn stent-graft |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: slow inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Outflow StenosisStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- W.L.Gore & Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642083
- Sponsor's protocol ID
- LTC-499-301107
- Acronym
- SHARE
- Status last verified
- Dec 2011
- First submitted
- 19 Mar 2008
- Last updated
- 15 Dec 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stenting of Haemodialysis Acces Re-stenosis Trial (SHARE Trial)
- ClinicalTrials.gov ID
- NCT00642083
- Acronym / sponsor ID
- SHARE / LTC-499-301107
- Conditions
- Outflow Stenosis
- Keywords
- outflow stenosis, stentgraft
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow inclusion
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- W.L.Gore & Associates
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 24 Mar 2008 (estimated)
- 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.
The purpose of this study is to demonstrate the efficacy of a PTFE covered stent-graft in the prevention of outflow re-stenosis in loop fistula in a prospective trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Viabahn stent-graftviabahn stent-graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of 18 years of age
- Patients have a life expectancy of at least 2 years
- Signed informed consent
- Recurrent stenosis at the venous anastomosis or in the draining vein of a loop arterio venous fistula, within 2 cm from the anastomosis.
Key exclusion criteria (4 listed)
- Patient unsuitable for administration of contrast agent
- Pregnancy
- Dementia or altered mental status that would prohibit giving conscious informed consent
- Need for adjunctive major surgical or vascular procedures within one month
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 |
|---|---|---|
| Viabahn stent-graftThe viabahn stent-graft is a combined ePTFE-Nitinol self-expanding stent-graft preloaded on a catheter-based delivery system. It was originally designed for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions with reference vessel diameters ranging from 4.8 to 7.5 mm. This device is also increasingly used for the exclusion of popliteal aneurysms. Its flexibility might make the device ideal for the treatment of recurrent outflow stenosis in AV loop-fistula. | Device | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: slow inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Viabahn stent-graft in people with Outflow Stenosis, run by Rijnstate Hospital at 1 site in Netherlands.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 15 Dec 2011. 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 Netherlands. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: slow inclusion). Results are not available in the source record.
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.
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 15 Dec 2011.