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Heparin-Coated Stent-Graft under the microscope: new analysis of nearly 1,000 patients

NCT ID NCT05459818

Knowledge-focused Sponsor: Rijnstate Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study combines data from nearly 1,000 patients who received a special stent-graft (the GORE VIABAHN with a heparin coating) for peripheral artery disease in the leg. Researchers want to see how well the device keeps arteries open over time and which patient factors affect success. The goal is to better understand who benefits most from this treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GORE® VIABAHN® endoprosthesis with heparin bioactive surface (a stent-graft device)
What this could lead to
If successful, this analysis could help doctors identify which patients with peripheral artery disease are most likely to benefit from this device, leading to better treatment decisions.
What could go wrong
This is a meta-analysis of existing studies, not a new trial. It cannot prove the device works better than other treatments, and results depend on the quality of the original studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

977 people

The number who actually took part.

Started

Oct 2022

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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. 2. Lesions ≥10 cm in length and TASC C or D classification will be included 3. Patient-level data can be obtained and pooled with other studies Exclusion Criteria: 1. Patient was not formally enrolled in their corresponding study (e.g., training cases) 2. Patient was enrolled for treatment of in-stent restenotic lesions. 3. Patient has incomplete or missing data that does not allow for analysis. 4. Case reports (n\<10 patients)

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Conditions

The condition(s) this trial relates to.

peripheral arterial disease peripheral vascular disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peripheral vascular diseases

Contacts and locations

Locations

  • Rijnstate

    Arnhem, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.