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Search / Trial NCT04907240

Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry

Launched by W.L.GORE & ASSOCIATES · May 25, 2021

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Viabahn Evar Propaten Iliac Sfa Sfa Isr Av Access Vaa Paa Trauma Injury

ClinConnect Summary

This clinical trial is studying the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface, a type of medical device used to treat various conditions affecting blood flow, such as Peripheral Artery Disease and aneurysms. The goal of the trial is to collect real-world data on how well this device works in patients after they receive it as part of their treatment. Researchers want to understand the outcomes and any potential benefits or issues that may arise from its use.

To participate in the trial, individuals must be at least 18 years old and provide their consent to join. They should also be deemed suitable for treatment with this device by their doctor. It's important for participants to be willing to follow the care guidelines set by the hospital or clinic. However, some people may not be eligible if they have certain medical conditions that could affect the trial results or if they cannot tolerate specific medications. Participants can expect regular follow-ups to monitor their health and how the device is working for them. Overall, this trial aims to enhance understanding of the device's effectiveness in everyday clinical settings.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age ≥ 18 years
  • 2. Signed informed consent form
  • 3. Suitable for endovascular treatment with VSX based on treating physician's best medical judgment
  • 4. Willingness of the patient to adhere to institutional standard of care follow-up requirements
  • Exclusion Criteria:
  • 1. Non-compliant lesions where full expansion of an angioplasty balloon catheter is not achievable during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system.
  • 2. Use of the VSX Device in lesions involving a major side branch that may be covered by the endoprosthesis.
  • 3. Lesion(s) cannot be treated with available VSX Device sizes per current Instructions for Use (IFU).
  • 4. Lesion requires treatment with an altered endoprosthesis or delivery system. (Do not cut the endoprosthesis. The endoprosthesis should only be placed and deployed using the supplied catheter system).
  • 5. Previous or concurrent enrollment into this registry (e.g., previous enrollment into another treatment cohort or patient requires enrollment into more than one cohort) (Note: Only the first VSX treatment will be enrolled if concurrent VSX procedures are performed that would require enrollment into more than one cohort).
  • 6. Participation in concurrent research study or registry which may confound registry results, unless approved by Gore.
  • 7. Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
  • 8. Unable to tolerate antiplatelet therapy.
  • 9. Patient has a non-controllable allergy to contrast or the VSX Device components.
  • 10. Pregnant or breast-feeding female at time of informed consent signature.
  • 11. Life expectancy \< 12 months due to comorbidities.
  • 12. Patient has other medical conditions which, as determined by the investigator, may confound the data interpretation (e.g., sepsis, thrombophilic diseases, connective tissue disorders).

About W.L.Gore & Associates

W.L. Gore & Associates is a pioneering medical device company renowned for its innovative contributions to the field of healthcare, particularly in vascular grafts, surgical meshes, and interventional devices. With a strong commitment to research and development, the company leverages advanced materials science to create products that enhance patient outcomes and improve the quality of care. W.L. Gore & Associates is dedicated to conducting clinical trials that rigorously evaluate the safety and efficacy of its products, ensuring compliance with regulatory standards and fostering collaboration with healthcare professionals worldwide. Through this commitment to excellence, the company aims to address unmet medical needs and advance the frontier of medical technology.

Locations

Barcelona, , Spain

Bristol, , United Kingdom

Arnhem, , Netherlands

Reinbek, , Germany

Tuebingen, , Germany

Frankfurt, , Germany

Malmo, , Sweden

London, , United Kingdom

Leeuwarden, , Netherlands

Heidelberg, , Germany

Solna, , Sweden

Barakaldo, , Spain

Brescia, , Italy

Brest, , France

Berchem Sainte Agathe, , Belgium

Angers, , France

Lyon, , France

Paris, , France

Hamburg, , Germany

Homburg, , Germany

Pavlos, , Greece

Ancona, , Italy

Torino, , Italy

Varese, , Italy

Vigo, , Spain

Glasgow, , United Kingdom

Strasbourg, , France

Modena, , Italy

Patients applied

0 patients applied

Trial Officials

Michel Reijnen, MD, PhD

Principal Investigator

Rijnstate Hospital, Arnhem, The Netherlands

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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