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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Peripheral Vascular Diseases
• Intervention / Treatment: Device: GORE VIABAHN VBX Balloon Expandable Endoprosthesis

• Study Type: Observational
• Enrollment (Actual): 280

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted in peripheral vessels in patients who require interventional treatment.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Mauro Gargiulo, MD, Azienda Ospedaliera Policlinico Sant'Orsola Malpighi

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2018
• Primary Completion (Actual): April 13, 2022
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: September 14, 2018
• First Submitted That Met QC Criteria: October 24, 2018
• First Posted (Actual): October 25, 2018

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Lesion-exclusion; Visceral Perfusion; Luminal Reconstruction; Occlusive Disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: VBX 17-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes