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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 2, 2020
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Tracking Information
First Submitted Date September 14, 2018
First Posted Date October 25, 2018
Last Update Posted Date January 2, 2020
Actual Study Start Date December 18, 2018
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 24, 2018)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
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.
Condition Peripheral Vascular Diseases
Intervention 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.
Study Groups/Cohorts 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.
Intervention: Device: GORE VIABAHN VBX Balloon Expandable Endoprosthesis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: December 30, 2019)
280
Original Estimated Enrollment
 (submitted: October 24, 2018)
140
Estimated Study Completion Date December 2021
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France,   Germany,   Italy,   Netherlands,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03720704
Other Study ID Numbers VBX 17-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party W.L.Gore & Associates
Study Sponsor W.L.Gore & Associates
Collaborators Not Provided
Investigators
Principal Investigator: Mauro Gargiulo, MD Azienda Ospedaliera Policlinico Sant'Orsola Malpighi
PRS Account W.L.Gore & Associates
Verification Date December 2019