Vascular Stent-Graft StenosisNCT04429243
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study
An observational study of Vascular Stent-Graft Stenosis, run by W.L.Gore & Associates at 17 sites in Japan.
Trial summary
This study will confirm the efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® stent graft (hereafter referred to as "Viabahn") for the treatment of patients with stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vascular Stent-Graft Stenosis
- What is being tested?
- GORE® VIABAHN® Stent Graft
- Type of treatment
- Medical device
- How many people
- 124 participants
- Where
- 17 sitesJapan
- Study dates
- 2 Jul 2020to 6 Oct 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with stenosis or occlusion at the venous anastomosis of synthetic arteriovenous (AV) access graft in Japan.
Who may be able to join
- Participants who developed stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft
- Participants who was used to repair vascular access circuits for purposes other than treatment of stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft
Who cannot join
None listed.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Japan17 sites
Kansai Rosai Hospital
Amagasaki, Hyōgo, 660-8511
Shizuoka General Hospital
Aoi, Shizuoka, 420-8527
Haruguchi Vascular Access Clinic
Chiyoda City, Tokyo, 102-0072
University of Yamanashi Hospital
Chūō, Yamanashi, 409-3898
Fukuoka City Hospital
Fukuoka, 812-0046
Ikeda Vascular Access, Dialysis and Internal Medicine Clinic
Fukuoka
Japanese Red Cross Kumamoto Hospital
Higashi, Kumamoto, 861-8520
Kanazawa Cardiovascular Hospital
Kanazawa, Ishikawa-ken, 920-0007
Saitama Medical Center
Kawagoe, Saitama, 350-8550
Matsuyama Red Cross Hospital
Matsuyama, Ehime, 790-8524
Kichijoji Asahi Hospital
Musashino, Tokyo, 180-0004
Kaikoukai Central Clinic
Nagoya, Aichi-ken, 454-0933
Nagoya Vascular Access Clinic
Nagoya, Aichi-ken, 464-0850
Bouseidai1 Clinic
Numazu, Shizuoka, 410-0043
Osaka Vascular Access Temma Nakamura Clinic
Osaka, 530-6012
Vascular Access Clinic Mejiro
Toshima City, Tokyo, 171-0031
Yokohama Dai-ichi Hospital
Yokohama, Kanagawa, 220-0011
About this study
Official title: GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study - Treatment of Patients With Stenosis or Occlusion at the Venous Anastomosis of Synthetic Arteriovenous (AV) Access Graft
This study will confirm the efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® stent graft (hereafter referred to as "Viabahn") for the treatment of patients with stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft.
- Conditions
- Vascular Stent-Graft Stenosis
- Being tested
- GORE® VIABAHN® Stent Graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE® VIABAHN® Stent GraftDevice
On Day 1, participants will receive the GORE® VIABAHN® Stent Graft.
| Study group | Role | What they receive |
|---|---|---|
| GORE® VIABAHN® Stent Graft | Participants will be examined 1, 3, 6, 12 and 24 months following the GORE® VIABAHN® Stent Graft installation. Receives: Device: GORE® VIABAHN® Stent Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Loss of Primary Patency of Target Lesion
Primary patency of target lesion is defined as the period during the patency was maintained from initial treatment until occlusion of target lesion or re-treatment of target lesion.
Measured: up to 2 years
Number of Subjects With Loss of Secondary Patency of Target Lesion
Secondary patency of target lesion is defined as the period during the patency was maintained from initial treatment (including the period of patency after re-treatment).
Measured: up to 2 years
Number of Subjects With Loss of Primary Patency of Vascular Access Circuit
Primary patency of vascular access circuit is defined as the period during the patency was maintained from initial treatment until occlusion in vascular access or re-treatment in vascular access circuit.
Measured: up to 2 years
Number of Subjects With Loss of Secondary Patency of Vascular Access Circuit
Secondary patency of vascular access circuit is defined as the period during the patency was maintained from initial treatment until discontinuation of the use of vascular access circuit.
Measured: up to 2 years
Mean Cumulative Number of Re-treatment Per Target Lesion
Mean cumulative number of re-treatment in target lesion is defined as the number of re-treatment performed for target lesion after the initial treatment.
Measured: at 24 months
Number of Subjects Achieving Technical Success
Technical Success is defined as < 30% residual stenosis after initial treatment.
Measured: Day 1
Number of Subjects Achieving Clinical Success
Clinical Success is defined as the resumption of normal dialysis for at least one session after the initial treatment.
Measured: Day 1 to Month 1 follow up
Number of Subjects Experiencing Device and Procedure-related Adverse Events
An adverse event (AE) is defined as any unfavorable or unintended sign (including abnormal laboratory changes), symptom, or illness associated with the use of a medical device. Unless worsening of severity or increasing of incidence during the surveillance, the primary disease of the patient is not considered an adverse event.
Measured: Day 1 to Month 1 follow up
Number of Subjects Experiencing Device Defects
A device defect is defined as a defect such as damage, malfunction, etc. that are widely unfavorable. Regardless of whether they are due to design, marketing, distribution, or use.
Measured: Day 1 to Month 1 follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start2 Jul 2020
- Primary completion6 Oct 2023
- Study completion6 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vascular Stent-Graft StenosisStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kei Kaneko, Study director, W. L. Gore & Associates G.K
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429243
- Sponsor's protocol ID
- JPS 19-05: AVR PMS
- Status last verified
- Oct 2024
- First submitted
- 27 May 2020
- Last updated
- 29 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study - Treatment of Patients With Stenosis or Occlusion at the Venous Anastomosis of Synthetic Arteriovenous (AV) Access Graft
- ClinicalTrials.gov ID
- NCT04429243
- Acronym / sponsor ID
- JPS 19-05: AVR PMS
- Conditions
- Vascular Stent-Graft Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Posted 29 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will confirm the efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® stent graft (hereafter referred to as "Viabahn") for the treatment of patients with stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GORE® VIABAHN® Stent Graft | – | Device: GORE® VIABAHN® Stent GraftParticipants will be examined 1, 3, 6, 12 and 24 months following the GORE® VIABAHN® Stent Graft installation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with stenosis or occlusion at the venous anastomosis of synthetic arteriovenous (AV) access graft in Japan.
Key inclusion criteria (2 listed)
- Participants who developed stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft
- Participants who was used to repair vascular access circuits for purposes other than treatment of stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| GORE® VIABAHN® Stent GraftOn Day 1, participants will receive the GORE® VIABAHN® Stent Graft. | Device | GORE® VIABAHN® Stent Graft |
Primary outcome
Number of Subjects With Loss of Primary Patency of Target Lesion
Time frame: up to 2 years
Primary patency of target lesion is defined as the period during the patency was maintained from initial treatment until occlusion of target lesion or re-treatment of target lesion.
Number of Subjects With Loss of Secondary Patency of Target Lesion
Time frame: up to 2 years
Secondary patency of target lesion is defined as the period during the patency was maintained from initial treatment (including the period of patency after re-treatment).
Number of Subjects With Loss of Primary Patency of Vascular Access Circuit
Time frame: up to 2 years
Primary patency of vascular access circuit is defined as the period during the patency was maintained from initial treatment until occlusion in vascular access or re-treatment in vascular access circuit.
Number of Subjects With Loss of Secondary Patency of Vascular Access Circuit
Time frame: up to 2 years
Secondary patency of vascular access circuit is defined as the period during the patency was maintained from initial treatment until discontinuation of the use of vascular access circuit.
Mean Cumulative Number of Re-treatment Per Target Lesion
Time frame: at 24 months
Mean cumulative number of re-treatment in target lesion is defined as the number of re-treatment performed for target lesion after the initial treatment.
Number of Subjects Achieving Technical Success
Time frame: Day 1
Technical Success is defined as < 30% residual stenosis after initial treatment.
Number of Subjects Achieving Clinical Success
Time frame: Day 1 to Month 1 follow up
Clinical Success is defined as the resumption of normal dialysis for at least one session after the initial treatment.
Number of Subjects Experiencing Device and Procedure-related Adverse Events
Time frame: Day 1 to Month 1 follow up
An adverse event (AE) is defined as any unfavorable or unintended sign (including abnormal laboratory changes), symptom, or illness associated with the use of a medical device. Unless worsening of severity or increasing of incidence during the surveillance, the primary disease of the patient is not considered an adverse event.
Number of Subjects Experiencing Device Defects
Time frame: Day 1 to Month 1 follow up
A device defect is defined as a defect such as damage, malfunction, etc. that are widely unfavorable. Regardless of whether they are due to design, marketing, distribution, or use.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kei Kaneko study director
W. L. Gore & Associates G.K
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Stent-Graft Stenosis, run by W.L.Gore & Associates at 17 sites in Japan.
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 2 inclusion and 0 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 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Japan. 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?
Yes. Results are posted in the registry (first posted 29 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With Loss of Primary Patency of Target Lesion (time frame: up to 2 years). The study lists 9 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 29 Nov 2024.