A Study of the Gore VIABAHN BX for Treatment of Occlusive Disease in the Iliac Arteries.
VBXFLEX
Evaluation of the Gore(R) Viabahn(R) Balloon Expandable Endoprosthesis (VIABAHN BX) for the Treatment of Occlusive Disease in the Common and External Iliac Arteries.
1 other identifier
interventional
134
2 countries
27
Brief Summary
Evaluation of the Gore(R) VIABAHN BX for the treatment of arterial occlusive disease in the common and/or external iliac arteries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2014
Longer than P75 for not_applicable
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2014
CompletedFirst Posted
Study publicly available on registry
March 6, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedResults Posted
Study results publicly available
July 17, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedJanuary 16, 2019
December 1, 2018
1.8 years
March 4, 2014
June 2, 2017
December 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite of Major Adverse Events (MAEs)
Percentage of study subjects experiencing a major adverse event (MAE) defined as: device or procedure-related death within 30 days, myocardial infarction (MI) within 30 days, target lesion revascularization (TLR) within 9 months or major amputation of the target limb within 9 months.
9 months
Secondary Outcomes (73)
Acute Procedural Success
Discharge
30-Day Clinical Success
30 Days
Percentage of Participants With Primary Patency
30 Days
Percentage of Participants With Primary Patency
9 Months
Percentage of Participants With Primary Assisted Patency
30 Days
- +68 more secondary outcomes
Other Outcomes (4)
Device or Procedure-related Death
30 Days
Myocardial Infarction (MI)
30 Days
Target Lesion Revascularization (TLR)
9 Months
- +1 more other outcomes
Study Arms (1)
Gore VIABAHN BX
EXPERIMENTALBalloon expandable stenting of iliac occlusive disease
Interventions
Balloon expandable stenting of iliac occlusive disease.
Eligibility Criteria
You may qualify if:
- Patient is at least 18 years old;
- Patient is male, infertile female, or female of childbearing potential practicing an acceptable method of preventing pregnancy;
- Patient or legal representative is willing to give written informed consent;
- Patient is capable of complying with protocol requirements, including all follow-up visits;
- Patient has symptomatic claudication or rest pain without tissue loss (Rutherford Categories 2-4).
- Patient has de novo or restenotic target lesion(s) in the common and/or external iliac artery;
- Patient has one or more regions of stenosis ≥ 50% in the target vessel, based on visual estimate;
- Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm;
- Patient has adequate ipsilateral blood flow including at least one sufficient (\<50% stenotic) infrapopliteal run-off vessel not requiring intervention (per side to be intervened on).
- Patient has a total target lesion length visually estimated to be ≤110 mm which can be treated with a maximum of three VIABAHN BX endoprostheses;
- Patient has no more than two discrete ipsilateral lesions that can be treated with no more than three VIABAHN BX endoprostheses \[OR\] Patient has bilateral disease consisting of only one target lesion per side that can be treated with no more than a total of three VIABAHN BX endoprostheses;
- Patient has the device advanced across the target lesion(s) and positioned for deployment.
You may not qualify if:
- Patient has a life expectancy of less than 1 year;
- Patient has a known allergy to stent graft components, including stainless steel or heparin;
- Patient has a known intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would prevent compliance with the protocol;
- Patient has a condition (unrelated to the study) that is expected to require indefinite, or lifelong, anticoagulation
- Patient has an uncorrected bleeding disorder (platelet count \< 80,000/µL);
- Patient has severe chronic renal insufficiency (serum creatinine level \> 2.5mg/dL) and not on hemodialysis;
- Patient has a known hypercoagulability that cannot be corrected;
- Patient has evidence of a blood borne infection;
- Patient has had vascular access/catheterization in the lower extremity within 30 days of study enrollment;
- Patient has had a previous or planned coronary intervention within 30 days prior to enrollment in this study or required at time of study procedure;
- Patient has had a previous or planned bypass surgery in the target leg, or a bypass that occurs at the time of the index procedure;
- Patient is currently participating in this or another investigative clinical study.
- Patient has a stent or stent graft located within or immediately adjacent (≤5mm) to study lesion(s);
- Patient has evidence of angiographically visible thrombus within or adjacent to the target lesion(s);
- Patient has aneurysmal dilation proximal or distal to the target lesion(s) that would interfere with the placement of the device;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
St. Luke's Medical Center
Phoenix, Arizona, 85006, United States
Yale University School of Medicine
New Haven, Connecticut, 06518, United States
MedStar Health Research Institute
Washington D.C., District of Columbia, 20782, United States
University of Miami
Miami, Florida, 33136, United States
Baptist Cardiac and Vascular Institute
Miami, Florida, 33176, United States
Coastal Vascular Institute
Pensacola, Florida, 32504, United States
Cardiovascular Associates
Elk Grove Village, Illinois, 60007, United States
Iowa Methodist Medical Center
West Des Moines, Iowa, 50266, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Essentia Institute for Rural Health / St Mary's Hospital
Duluth, Minnesota, 55805, United States
North Memorial Heart & Vascular Institute
Plymouth, Minnesota, 55422, United States
Advanced Vascular Associates
Morristown, New Jersey, 07960, United States
Holy Name Medical Center
Teaneck, New Jersey, 07666, United States
Research Foundation SUNY Buffalo
Buffalo, New York, 14203, United States
Cornell University
New York, New York, 10065, United States
Sanford Clinic - Clinical Research
Fargo, North Dakota, 58122, United States
Ohio Health
Columbus, Ohio, 43214, United States
Holy Spirit Cardiovascular Institute
Camp Hill, Pennsylvania, 17011, United States
UPMC
Pittsburgh, Pennsylvania, 15213, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
MUSC
Charleston, South Carolina, 29425, United States
Greenville Memorial Hospital
Greenville, South Carolina, 29615, United States
University Surgical Associates
Chattanooga, Tennessee, 37403, United States
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660, United States
The Methodist Hospital
Houston, Texas, 77030, United States
Sentara Medical Group
Norfolk, Virginia, 23507, United States
Auckland City Hospital
Auckland, New Zealand
Related Publications (3)
Holden A, Takele E, Hill A, Sakhuja R, Metzger C, Gray BH, Cavadino A. Long-Term Follow-up of Subjects With Iliac Occlusive Disease Treated With the Viabahn VBX Balloon-Expandable Endoprosthesis. J Endovasc Ther. 2025 Feb;32(1):68-76. doi: 10.1177/15266028231165723. Epub 2023 Apr 19.
PMID: 37073512DERIVEDPanneton JM, Bismuth J, Gray BH, Holden A. Three-Year Follow-up of Patients With Iliac Occlusive Disease Treated With the Viabahn Balloon- Expandable Endoprosthesis. J Endovasc Ther. 2020 Oct;27(5):728-736. doi: 10.1177/1526602820920569. Epub 2020 Apr 24.
PMID: 32329658DERIVEDBismuth J, Gray BH, Holden A, Metzger C, Panneton J; VBX FLEX Study Investigators. Pivotal Study of a Next-Generation Balloon-Expandable Stent-Graft for Treatment of Iliac Occlusive Disease. J Endovasc Ther. 2017 Oct;24(5):629-637. doi: 10.1177/1526602817720463. Epub 2017 Jul 12.
PMID: 28697693DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Hector R Novoa
- Organization
- W.L. Gore & Associates
Study Officials
- PRINCIPAL INVESTIGATOR
Jean Bismuth, MD
The Methodist Hospital Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2014
First Posted
March 6, 2014
Study Start
July 1, 2014
Primary Completion
May 1, 2016
Study Completion
October 1, 2018
Last Updated
January 16, 2019
Results First Posted
July 17, 2018
Record last verified: 2018-12