Post-Market Registry of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Implanted in Peripheral Vessels (EXPAND)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03720704|
Recruitment Status : Enrolling by invitation
First Posted : October 25, 2018
Last Update Posted : January 10, 2019
|Condition or disease||Intervention/treatment|
|Peripheral Vascular Diseases||Device: GORE VIABAHN VBX Balloon Expandable Endoprosthesis|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||140 participants|
|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|
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.
- 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.
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
|Hôpital Marie Lannelongue|
|University Hospital Heidelberg|
|St. Franziskus Hospital|
|Azienda Ospedaliera Policlinico Sant'Orsola Malpighi|
|Azienda Ospedaliero-Universitaria di Padova|
|Ospedale di Circolo e Fondazione Macchi|
|University Medical Center Groningen|
|Erasmus Medical Center|
|Hospital Universitario Central de Asturias (HUCA)|
|University Hospital of Santiago de Compostela|
|Santiago De Compostela, Spain|
|Principal Investigator:||Mauro Gargiulo, MD||Azienda Ospedaliera Policlinico Sant'Orsola Malpighi|