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

Study Overview
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Brief Summary
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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

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

Conditions
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Peripheral Vascular Diseases

Intervention / Treatment
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* Device: GORE VIABAHN VBX Balloon Expandable Endoprosthesis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis<br>The GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted according to the institution standard of practice in patients needing preservation of peripheral vessels due to multiple pathologies and conditions. | Device: GORE VIABAHN VBX Balloon Expandable Endoprosthesis<br>* GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted in peripheral vessels in patients who require interventional treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of Procedural Success and freedom from VBX Stent Graft-related Serious Adverse Events | 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. | 30 days post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lesion-exclusion, Visceral Perfusion, Luminal Reconstruction, Occlusive Disease