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Active, Not Recruiting

NCT Number: NCT03720704

Post-Market Registry of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Implanted in Peripheral Vessels

The primary objective of the VBX 17-04 registry is to collect post-market safety and performance data of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) in peripheral vessels in patients who require interventional treatment

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Marie Lannelongue, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • Signed informed consent form
  • Endovascular indication for treatment based on treating physician's best medical judgment.
  • Intend for no other stents to be placed in the same peripheral vessel(s) targeted for VBX Stent Graft placement.
  • Willingness of the patient to adhere to standard of care follow-up requirements.

Exclusion criteria

  • Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
  • Participation in concurrent research study or registry which may confound registry results, unless approved by Gore.
  • Pregnant or breast-feeding female at time of informed consent signature.
  • Life expectancy < 12 months due to comorbidities.
  • Use of the VBX Stent Graft is for the treatment of de novo iliac occlusive disease.
  • Use of the VBX Stent Graft is for the treatment of aortic coarctations.
  • Use of the VBX Stent Graft in the coronary, pulmonary, carotid, vertebral, isolated infrarenal aortic, or vena cava vessels.

Treatment and study plan

GORE VIABAHN VBX Balloon Expandable Endoprosthesis

Device

GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted in peripheral vessels in patients who require interventional treatment.

Primary outcomes

  1. Composite of Procedural Success and Freedom From VBX Stent Graft-related Serious Adverse Events

    Time frame: 30 days post treatment

    Number of study subjects experiencing Procedural Success and free from VBX Stent Graft-related Serious Adverse Events within 30 days of index procedure.

    Procedural Success is defined as: successful access, delivery, accurate deployment, and withdrawal of catheters with patent VBX Stent Graft at end of procedure.

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Acronym: EXPAND

Important dates

Study start
2018
Primary completion
2022
Study completion
2027
First posted
Oct 25, 2018
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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