Peripheral Vascular DiseasesInsight-VSXNCT05459818
Individual Patient Data Analysis of Viabahn for Peripheral Arterial Disease
An observational study of Peripheral Vascular Diseases, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
To evaluate the effectiveness of the VSX device in pre-determined patient populations to understand the patient characteristics that impact outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Vascular Diseases
- What is being tested?
- Viabahn implanted
- Type of treatment
- Medical device
- How many people
- 977 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Oct 2022to 1 Oct 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: An individual patient data analysis obtained from databases used in prospective studies that published results of patients treated with the latest generation heparin-bonded Viabahn in the femoropopliteal artery. For this purpose authors are asked to provide extensive patient information (anonymized): patient characteristics at baseline (e.g. comorbidities), lesion details, procedural details, hospitalization details, follow-up visits.
Who may be able to join
- Patient was enrolled and treated with the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface device in a Gore-sponsored or physician-sponsored study for de novo or restenotic lesions of the femoropopliteal artery.
- Lesions ≥10 cm in length and TASC C or D classification will be included
- Patient-level data can be obtained and pooled with other studies
Who cannot join
- Patient was not formally enrolled in their corresponding study (e.g., training cases)
- Patient was enrolled for treatment of in-stent restenotic lesions.
- Patient has incomplete or missing data that does not allow for analysis.
- Case reports (n<10 patients)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individual Patient Data Meta-Analysis of Prospective Studies of Patients Treated With the GORE® VIABAHN® Endoprosthesis With Heparin Bioactive Surface (VSX) for Peripheral Arterial Disease (INSIGHT VSX)
To evaluate the effectiveness of the VSX device in pre-determined patient populations to understand the patient characteristics that impact outcomes.
Read the detailed description
Rationale: Studies on the efficacy of self-expanding covered stents for the treatment of patients with superficial femoral artery (SFA) occlusive disease have mainly focused on stent patency. Subgroup analysis was often not feasible, related to small sample sizes. This pooled analysis of individual patient-level data provides larger sample sizes and a more heterogeneous population, which allows for the ability to perform subgroup analyses to identify patients that will most benefit from VSX treatment. The current analysis will provide insights into the effectiveness of the VSX device for specific subgroups.
Objective: To evaluate the effectiveness of the VSX device in pre-determined patient populations to understand the patient characteristics that impact outcomes.
Study design: Multicenter retrospective individual patient data meta-analysis. Study population: Patients treated with a VSX device for de novo or restenotic lesions of the superficial femoral artery and previously enrolled in a prospective VSX study whom were treated for SFA disease with the latest generation heparin-bonded Viabahn, and published in peer reviewed journals.
Main study parameters/endpoints: The primary study parameter is primary patency at 12-months. In addition, for all subjects and for subgroups as described further below, the following secondary endpoints will be evaluated through follow-up: primary patency at 24 months, primary assisted patency, secondary patency, freedom from Target Lesion Revascularization (TLR) at 12 and 24 months, clinical Improvement, minor and major amputation, mortality. The following subgroup analysis will be performed if sufficient data are available: critical limb threatening ischemia patients (Rutherford 4-6), patients with intermittent claudication (Rutherford 1-3), chronic total occlusions, by gender, by number of runoff vessels, lesion length, TASC II lesion classification, calcified lesions, by device diameter.
- Conditions
- Peripheral Vascular Diseases
- Being tested
- Viabahn implanted
- Keywords
- peripheral artarial disease, endovascular treatment, endoprosthesis, Viabahn, Individual patient data analysis
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viabahn implantedDevice
Also called endovascular treatment
An individual patient data analysis obtained from databases used in prospective studies that published results of patients treated with the latest generation heparin-bonded Viabahn in the femoropopliteal artery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency
Primary patency is defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-coded duplex sonography (CDUS, PSVR < 2.5) or no angiographic evidence of stenosis > 50% if CDUS is uninterpretable or unavailable.
Measured: at 12 months.
Secondary outcomes (7)
Primary patency
Primary patency is defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-coded duplex sonography (CDUS, PSVR < 2.5) or no angiographic evidence of stenosis > 50% if CDUS is uninterpretable or unavailable.
Measured: at 24 months
Primary assisted patency
Primary assisted patency is defined as flow through the treated lesion with or without repeat percutaneous intervention completed prior to complete vessel occlusion.
Measured: 12 and 24 months
Secondary patency
Secondary patency is defined as patency in the target lesion maintained by repeat intervention after complete occlusion of the treated arterial segment.
Measured: 12 and 24 months
Freedom from Target Lesion Revascularization (TLR)
Freedom from revascularization of the treated lesion after either restenosis or occlusion by means of a percutaneous vascular intervention, surgical by-pass, thrombolysis, or other such invasive means.
Measured: 12 and 24 months
Clinical Improvement
Clinical improvement is defined as at least one-group improvement in Rutherford Classification compared to baseline.
Measured: 12 and 24 months
Major amputation
Surgical removal of a portion of the study limb (generally above the ankle, transmetatarsal, or metatarsal)
Measured: 12 and 24 months
Mortality
Death, overall and procedure-related (until 30 days)
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start12 Oct 2022
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseasesStudies 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
- 977 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MMPJ Reijnen, Prof, Principal investigator, Rijnstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459818
- Sponsor's protocol ID
- 2022-2052
- Acronym
- Insight-VSX
- Status last verified
- Jan 2026
- First submitted
- 6 Jul 2022
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: On request data can be shared with other researchers after publication of the data; consent needs to be collected from all collaborators
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Patient Data Meta-Analysis of Prospective Studies of Patients Treated With the GORE® VIABAHN® Endoprosthesis With Heparin Bioactive Surface (VSX) for Peripheral Arterial Disease (INSIGHT VSX)
- ClinicalTrials.gov ID
- NCT05459818
- Acronym / sponsor ID
- Insight-VSX / 2022-2052
- Conditions
- Peripheral Vascular Diseases
- Keywords
- peripheral artarial disease, endovascular treatment, endoprosthesis, Viabahn, Individual patient data analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 977 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 15 Jul 2022 (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.
To evaluate the effectiveness of the VSX device in pre-determined patient populations to understand the patient characteristics that impact outcomes.
Detailed description
Rationale: Studies on the efficacy of self-expanding covered stents for the treatment of patients with superficial femoral artery (SFA) occlusive disease have mainly focused on stent patency. Subgroup analysis was often not feasible, related to small sample sizes. This pooled analysis of individual patient-level data provides larger sample sizes and a more heterogeneous population, which allows for the ability to perform subgroup analyses to identify patients that will most benefit from VSX treatment. The current analysis will provide insights into the effectiveness of the VSX device for specific subgroups.
Objective: To evaluate the effectiveness of the VSX device in pre-determined patient populations to understand the patient characteristics that impact outcomes.
Study design: Multicenter retrospective individual patient data meta-analysis. Study population: Patients treated with a VSX device for de novo or restenotic lesions of the superficial femoral artery and previously enrolled in a prospective VSX study whom were treated for SFA disease with the latest generation heparin-bonded Viabahn, and published in peer reviewed journals.
Main study parameters/endpoints: The primary study parameter is primary patency at 12-months. In addition, for all subjects and for subgroups as described further below, the following secondary endpoints will be evaluated through follow-up: primary patency at 24 months, primary assisted patency, secondary patency, freedom from Target Lesion Revascularization (TLR) at 12 and 24 months, clinical Improvement, minor and major amputation, mortality. The following subgroup analysis will be performed if sufficient data are available: critical limb threatening ischemia patients (Rutherford 4-6), patients with intermittent claudication (Rutherford 1-3), chronic total occlusions, by gender, by number of runoff vessels, lesion length, TASC II lesion classification, calcified lesions, by device diameter.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- An individual patient data analysis obtained from databases used in prospective studies that published results of patients treated with the latest generation heparin-bonded Viabahn in the femoropopliteal artery. For this purpose authors are asked to provide extensive patient information (anonymized): patient characteristics at baseline (e.g. comorbidities), lesion details, procedural details, hospitalization details, follow-up visits.
Key inclusion criteria (3 listed)
- Patient was enrolled and treated with the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface device in a Gore-sponsored or physician-sponsored study for de novo or restenotic lesions of the femoropopliteal artery.
- Lesions ≥10 cm in length and TASC C or D classification will be included
- Patient-level data can be obtained and pooled with other studies
Key exclusion criteria (4 listed)
- Patient was not formally enrolled in their corresponding study (e.g., training cases)
- Patient was enrolled for treatment of in-stent restenotic lesions.
- Patient has incomplete or missing data that does not allow for analysis.
- Case reports (n<10 patients)
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 implantedAlso: endovascular treatmentAn individual patient data analysis obtained from databases used in prospective studies that published results of patients treated with the latest generation heparin-bonded Viabahn in the femoropopliteal artery. | Device | – |
Primary outcome
Primary patency
Time frame: at 12 months.
Primary patency is defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-coded duplex sonography (CDUS, PSVR < 2.5) or no angiographic evidence of stenosis > 50% if CDUS is uninterpretable or unavailable.
7 secondary outcomes
Primary patency
Time frame: at 24 months
Primary assisted patency
Time frame: 12 and 24 months
Secondary patency
Time frame: 12 and 24 months
Freedom from Target Lesion Revascularization (TLR)
Time frame: 12 and 24 months
Clinical Improvement
Time frame: 12 and 24 months
Major amputation
Time frame: 12 and 24 months
Mortality
Time frame: 12 and 24 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 7 Jan 2026.
- Individual participant dataSharing planned: No. On request data can be shared with other researchers after publication of the data; consent needs to be collected from all collaborators
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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.
MMPJ Reijnen, Prof principal investigator
Rijnstate
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 Vascular Diseases, 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 3 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: finished, as of the sponsor's last update on 7 Jan 2026. 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.
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?
Primary patency (time frame: at 12 months.). 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 7 Jan 2026.