Clinical trial NCT03720704: Post-Market Registry of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Implanted in Peripheral Vessels
Official title: Post-Market Registry of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Implanted in Peripheral Vessels
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Peripheral Vascular Diseases
Keywords: Lesion-exclusion
Visceral Perfusion
Luminal Reconstruction
Occlusive Disease
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2018-10-25
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility 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.

Primary outcomes:
measure: Composite of Procedural Success and Freedom From VBX Stent Graft-related Serious Adverse Events
timeFrame: 30 days post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Marie Lannelongue
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
city: Münster
country: Germany
facility: St. Franziskus Hospital
city: Bologna
country: Italy
facility: Azienda Ospedaliera Policlinico Sant'Orsola Malpighi
city: Brescia
country: Italy
facility: Fondazione Poliambulanza
city: Padova
country: Italy
facility: Azienda Ospedaliero-Universitaria di Padova
city: Varese
country: Italy
facility: Ospedale di Circolo e Fondazione Macchi
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias (HUCA)
city: Santiago De Compostela
country: Spain
facility: University Hospital of Santiago de Compostela
Study officials:
affiliation: Azienda Ospedaliera Policlinico Sant'Orsola Malpighi
name: Mauro Gargiulo, MD
role: PRINCIPAL_INVESTIGATOR
References: