GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)

An observational study of Peripheral Arterial Disease, run by W.L.Gore & Associates at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will confirm device efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® Endoprosthesis for the treatment of symptomatic peripheral arterial disease in the superficial femoral arteries. Read more about this study

Who is it for?: Any age
Conditions the study is for: Peripheral Arterial Disease
What is being tested?: GORE® VIABAHN® Endoprosthesis
Type of treatment: Medical device
How many people: 321 participants
Where: 1 siteJapan
Study dates: 25 Aug 2016to 14 Dec 2022
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 symptomatic peripheral arterial disease in superficial femoral artery lesions in Japan

Who may be able to join

Symptomatic peripheral arterial disease in superficial femoral artery lesions

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Kansai Rousai
Amagasaki, Hyōgo

Other trials in Japan

About this study

Conditions: Peripheral Arterial Disease
Being tested: GORE® VIABAHN® Endoprosthesis
Medical subject headings: Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GORE® VIABAHN® EndoprosthesisDevice
Participants receiving the GORE® VIABAHN® Endoprosthesis

Study groups in NCT04706273
Study group	Role	What they receive
GORE® VIABAHN® Endoprosthesis		Participants with symptomatic peripheral arterial disease in superficial femoral artery lesions. Receives: Device: GORE® VIABAHN® Endoprosthesis

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Assisted Patency
Primary assisted patency is defined as hemodynamic evidence of flow through a device that had not required a Target lesion revascularization to restore flow after total occlusion. Kaplan-Meier estimates created for each time point.
Measured: 12 and 24 months
Freedom From Target Lesion Revascularization
Revascularization for restenosis or occlusion of the target lesion. Kaplan-Meier estimates created for each time point.
Measured: 1, 12 and 24 months
Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies
The number and proportion of the subjects for whom the occurrence of serious adverse events were reported.
Measured: Procedure day, 1, 12, 24, 36, 48 and 60 months
Number of Participants With a Stent Fracture
The number and proportion of stent fracture as assessed by Core lab
Measured: Month 12, 24, 36, 48 and 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Aug 201614 Dec 2022

First posted12 Jan 2021
Study start25 Aug 2016
Primary completion11 Jul 2019
Study completion14 Dec 2022

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Peripheral Arterial DiseaseStudies 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: 321 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04706273
Sponsor's protocol ID: JPS 16-03
Status last verified: Oct 2023
First submitted: 8 Jan 2021
Last updated: 20 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Iida O, Ohki T, Soga Y, Suematsu N, Nakama T, Yamaoka T, Tobita K, Ichihashi S. Five-year outcomes of the GORE VIABAHN Endoprosthesis for the treatment of complex femoropopliteal lesions from a Japanese postmarket surveillance study. Vasc Med. 2024 Aug;29(4):416-423. doi: 10.1177/1358863X241233528. Epub 2024 Mar 27.
PubMed 38544413

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
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Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
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Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)

All Peripheral Arterial Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)
ClinicalTrials.gov ID: NCT04706273
Acronym / sponsor ID: JPS 16-03
Conditions: Peripheral Arterial Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 321 participants (actual)
Lead sponsor: W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
Study start: 25 Aug 2016 (actual)
Primary completion: 11 Jul 2019 (actual)
Study completion: 14 Dec 2022 (actual)
First posted: 12 Jan 2021 (actual)
Results: Posted 20 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
GORE® VIABAHN® Endoprosthesis	–	Device: GORE® VIABAHN® EndoprosthesisParticipants with symptomatic peripheral arterial disease in superficial femoral artery lesions.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with symptomatic peripheral arterial disease in superficial femoral artery lesions in Japan

Key inclusion criteria (1 listed)

Symptomatic peripheral arterial disease in superficial femoral artery lesions

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® EndoprosthesisParticipants receiving the GORE® VIABAHN® Endoprosthesis	Device	GORE® VIABAHN® Endoprosthesis

Primary outcome

Primary Assisted Patency
Time frame: 12 and 24 months
Primary assisted patency is defined as hemodynamic evidence of flow through a device that had not required a Target lesion revascularization to restore flow after total occlusion. Kaplan-Meier estimates created for each time point.
Freedom From Target Lesion Revascularization
Time frame: 1, 12 and 24 months
Revascularization for restenosis or occlusion of the target lesion. Kaplan-Meier estimates created for each time point.
Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies
Time frame: Procedure day, 1, 12, 24, 36, 48 and 60 months
The number and proportion of the subjects for whom the occurrence of serious adverse events were reported.
Number of Participants With a Stent Fracture
Time frame: Month 12, 24, 36, 48 and 60
The number and proportion of stent fracture as assessed by Core lab

Results and safety

Results posted to the registry on 20 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GORE® VIABAHN® Endoprosthesis	321	136

Primary outcome: Primary Assisted Patency

Time frame: 12 and 24 months. Number (95% Confidence Interval). Unit: probability

Measure	GORE® VIABAHN® Endoprosthesis n = 321
12 months	0.920 (0.880 to 0.946)
24 months	0.873 (0.826 to 0.908)

Population analysed: Participant limbs treated

Primary outcome: Freedom From Target Lesion Revascularization

Time frame: 1, 12 and 24 months. Number (95% Confidence Interval). Unit: probability

Measure	GORE® VIABAHN® Endoprosthesis n = 321
1 Month	0.997 (0.978 to 1.000)
12 Months	0.924 (0.887 to 0.949)
24 Months	0.844 (0.797 to 0.881)

Population analysed: Participant limbs treated

Primary outcome: Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies

Time frame: Procedure day, 1, 12, 24, 36, 48 and 60 months. Count of participants. Unit: Participants

Measure	GORE® VIABAHN® Endoprosthesis n = 321
Procedure (Day 0)	7
1 Month (Days 0 through 37)	11
3 Months (Days 38 through 121)	3
6 Months (Days 122 through 212)	9
12 Months (Days 213 through 395)	17
24 Months (Days 396 through 760)	20
36 Months (Days 761 through 1277)	13
48 Months (Days 1278 through 1642)	7

Population analysed: Participants must have been followed for at least as long as the start day identified for the time period. Participants that discontinued prior to the start day of the time period were not included in the number analyzed.

Primary outcome: Number of Participants With a Stent Fracture

Time frame: Month 12, 24, 36, 48 and 60. Count of participants. Unit: Participants

Measure	GORE® VIABAHN® Endoprosthesis n = 321
12 Months	0
24 Months	0
36 Months	0
48 Months	0
60 Months	0

Population analysed: Includes all subjects who had an x-ray to determine device stent fracture status at the reported corresponding follow-up time period.

Adverse events

Time frame: 60 months (Days 0 through 1855). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GORE® VIABAHN® Endoprosthesis	188 of 321 (58.6%)	0 of 321 (0%)	85 of 321

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38544413Iida O, Ohki T, Soga Y, Suematsu N, Nakama T, Yamaoka T, Tobita K, Ichihashi S. Five-year outcomes of the GORE VIABAHN Endoprosthesis for the treatment of complex femoropopliteal lesions from a Japanese postmarket surveillance study. Vasc Med. 2024 Aug;29(4):416-423. doi: 10.1177/1358863X241233528. Epub 2024 Mar 27.

Related trials for Peripheral Arterial Disease

Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)

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?

An observational study of Peripheral Arterial Disease, run by W.L.Gore & Associates at 1 site 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 1 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 20 Sep 2024. 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 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 20 Sep 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?

Primary Assisted Patency (time frame: 12 and 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04706273, which also lists 1 linked publication.

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 20 Sep 2024.