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

NCT03720704 | Active Not Recruiting Results FDA Device

• 1 other identifier: VBX 17-04
• Study Type: observational
• Target: 280
• Locations: 5 countries
• Sites: 11

Brief 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

Conditions

Peripheral Vascular Diseases

Keywords

Lesion-exclusion; Visceral Perfusion; Luminal Reconstruction; Occlusive Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Device: GORE VIABAHN VBX Balloon Expandable Endoprosthesis

Interventions

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.

GORE VIABAHN VBX Balloon Expandable Endoprosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The registry has been designed with broad eligibility criteria to capture real-world VBX Stent Graft use, in multiple pathologies and in conditions needing preservation of peripheral vessels.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (11)

Hôpital Marie Lannelongue

Paris, France

Location

University Hospital Heidelberg

Heidelberg, Germany

Location

St. Franziskus Hospital

Münster, Germany

Location

Azienda Ospedaliera Policlinico Sant'Orsola Malpighi

Bologna, Italy

Location

Fondazione Poliambulanza

Brescia, Italy

Location

Azienda Ospedaliero-Universitaria di Padova

Padova, Italy

Location

Ospedale di Circolo e Fondazione Macchi

Varese, Italy

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Hospital Universitario Central de Asturias (HUCA)

Oviedo, Spain

Location

University Hospital of Santiago de Compostela

Santiago de Compostela, Spain

Location

Related Publications (1)

• Usai MV, Gargiulo M, Haulon S, Tielliu I, Boeckler D, Verhagen H, Fernandez AM, Austermann MJ. One-year results of a balloon expandable endoprosthesis as a bridging stent for branched endovascular aortic repair. J Vasc Surg. 2023 Dec;78(6):1376-1382.e2. doi: 10.1016/j.jvs.2023.07.061. Epub 2023 Aug 11.

  PMID: 37572891 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Austin Phillips
• Organization: W. L. Gore & Associates

agphilli@wlgore.com

+1 928 864 3641

Study Officials

• Mauro Gargiulo, MD

  Azienda Ospedaliera Policlinico Sant'Orsola Malpighi

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: October 25, 2018
• Study Start: December 18, 2018
• Primary Completion: April 13, 2022
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 14, 2026
• Results First Posted: February 16, 2024

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2); DE (2); FR (1); ES (2); IT (4)