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

W.L. Gore & Associates

Status: Active, not recruiting

Conditions: Peripheral Vascular Diseases

Treatments: Device: GORE VIABAHN VBX Balloon Expandable Endoprosthesis

Study type: Observational

Funder types: Industry

Identifiers

NCT03720704

VBX 17-04

Details and patient eligibility

About

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

Enrollment: 280 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

280 participants in 1 patient group

GORE VIABAHN VBX Balloon Expandable Endoprosthesis

Description:

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.

Treatment:

Device: GORE VIABAHN VBX Balloon Expandable Endoprosthesis