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

Peripheral Vascular Diseases Clinical Trial

— EXPAND  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03720704
• Other study ID #: VBX 17-04
• Status: Active, not recruiting
• Start date: December 18, 2018
• Est. completion date: March 2026

Study information

• Verified date: February 2024
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 280
• Est. completion date: March 2026
• Est. primary completion date: April 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Marie Lannelongue	Paris
Germany	University Hospital Heidelberg	Heidelberg
Germany	St. Franziskus Hospital	Münster
Italy	Azienda Ospedaliera Policlinico Sant'Orsola Malpighi	Bologna
Italy	Fondazione Poliambulanza	Brescia
Italy	Azienda Ospedaliero-Universitaria di Padova	Padova
Italy	Ospedale di Circolo e Fondazione Macchi	Varese
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Erasmus Medical Center	Rotterdam
Spain	Hospital Universitario Central de Asturias (HUCA)	Oviedo
Spain	University Hospital of Santiago de Compostela	Santiago De Compostela

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Countries where clinical trial is conducted

France,  Germany,  Italy,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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