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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

280 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-18

Study Completion Date

2027-07-31

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

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Detailed Description

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Conditions

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Peripheral Vascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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GORE VIABAHN VBX Balloon Expandable Endoprosthesis

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.

GORE VIABAHN VBX Balloon Expandable Endoprosthesis

Intervention Type DEVICE

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

Interventions

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GORE VIABAHN VBX Balloon Expandable Endoprosthesis

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

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No