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

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ClinicalTrials.gov Identifier: NCT03720704
Recruitment Status : Enrolling by invitation
First Posted : October 25, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

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

Condition or disease Intervention/treatment
Peripheral Vascular Diseases Device: GORE VIABAHN VBX Balloon Expandable Endoprosthesis

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Post-Market Registry of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Implanted in Peripheral Vessels
Actual Study Start Date : December 18, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2020

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.




Primary Outcome Measures :
  1. Composite of Procedural Success and freedom from VBX Stent Graft-related Serious Adverse Events [ Time Frame: 30 days post treatment ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03720704


Locations
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France
Hôpital Marie Lannelongue
Paris, France
Germany
University Hospital Heidelberg
Heidelberg, Germany
St. Franziskus Hospital
Münster, Germany
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, Italy
Netherlands
University Medical Center Groningen
Groningen, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Spain
Hospital Universitario Central de Asturias (HUCA)
Oviedo, Spain
University Hospital of Santiago de Compostela
Santiago De Compostela, Spain
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
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Principal Investigator: Mauro Gargiulo, MD Azienda Ospedaliera Policlinico Sant'Orsola Malpighi

Additional Information:

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Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT03720704     History of Changes
Other Study ID Numbers: VBX 17-04
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by W.L.Gore & Associates:
Lesion-exclusion
Visceral Perfusion
Luminal Reconstruction
Occlusive Disease

Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases