Peripheral Arterial DiseaseVBXFLEXNCT02080871
A Study of the Gore VIABAHN BX for Treatment of Occlusive Disease in the Iliac Arteries.
A study testing Stenting of the Common and/or External Iliac Arteries in people with Peripheral Arterial Disease, run by W.L.Gore & Associates at 27 sites in 2 countries.
Trial summary
Evaluation of the Gore(R) VIABAHN BX for the treatment of arterial occlusive disease in the common and/or external iliac arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Stenting of the Common and/or External Iliac Arteries
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 27 sitesin 2 countries
- Study dates
- Jul 2014to Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 12Show fewer
- 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.
Who cannot join
- 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;
Show all 17Show fewer
- 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;
- Patient has a target lesion requiring atherectomy or any ablative device to facilitate stent delivery;
- Patient has a target lesion situated in such a way that an implanted device will prevent blood flow or perfusion to the internal iliac artery if patent.
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
United States26 sites
Research Foundation SUNY Buffalo
Buffalo, New York, 14203
Holy Spirit Cardiovascular Institute
Camp Hill, Pennsylvania, 17011
MUSC
Charleston, South Carolina, 29425
University Surgical Associates
Chattanooga, Tennessee, 37403
Ohio Health
Columbus, Ohio, 43214
Essentia Institute for Rural Health / St Mary's Hospital
Duluth, Minnesota, 55805
Cardiovascular Associates
Elk Grove Village, Illinois, 60007
Sanford Clinic - Clinical Research
Fargo, North Dakota, 58122
Greenville Memorial Hospital
Greenville, South Carolina, 29615
The Methodist Hospital
Houston, Texas, 77030
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660
University of Louisville
Louisville, Kentucky, 40202
University of Miami
Miami, Florida, 33136
Baptist Cardiac and Vascular Institute
Miami, Florida, 33176
Advanced Vascular Associates
Morristown, New Jersey, 07960
Yale University School of Medicine
New Haven, Connecticut, 06518
Cornell University
New York, New York, 10065
Sentara Medical Group
Norfolk, Virginia, 23507
Coastal Vascular Institute
Pensacola, Florida, 32504
St. Luke's Medical Center
Phoenix, Arizona, 85006
UPMC
Pittsburgh, Pennsylvania, 15213
North Memorial Heart & Vascular Institute
Plymouth, Minnesota, 55422
The Miriam Hospital
Providence, Rhode Island, 02906
Holy Name Medical Center
Teaneck, New Jersey, 07666
MedStar Health Research Institute
Washington D.C., District of Columbia, 20782
Iowa Methodist Medical Center
West Des Moines, Iowa, 50266
About this study
Official title: 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.
Evaluation of the Gore(R) VIABAHN BX for the treatment of arterial occlusive disease in the common and/or external iliac arteries.
Read the detailed description
This study is a prospective, multicenter, non-randomized single-arm clinical study to evaluate the safety and efficacy of the VIABAHN BX for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or external iliac arteries.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Stenting of the Common and/or External Iliac Arteries
- Keywords
- PAD, Stent, Claudication, Viabahn, Gore, Endoprosthesis, Vascular Diseases, Cardiovascular Diseases, Iliac Occlusive Disease, Balloon Expandable, Stent-graft, VBX
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stenting of the Common and/or External Iliac ArteriesDevice
Balloon expandable stenting of iliac occlusive disease.
| Study group | Role | What they receive |
|---|---|---|
| Gore VIABAHN BX | Experimental | Balloon expandable stenting of iliac occlusive disease Receives: Device: Stenting of the Common and/or External Iliac Arteries |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (73)
Acute Procedural Success
Number of subjects who experienced Acute Procedural Success defined as less than or equal to 30% residual stenosis prior to procedure completion and no device- or procedure-related SAEs before discharge.
Measured: Discharge
30-Day Clinical Success
Number of subjects who experienced 30-Day Clinical Success defined as an improvement of at least one Rutherford Category at the 30-day visit as compared to pre-procedure and no device- or procedure-related SAEs within 30 days of the index procedure.
Measured: 30 Days
Percentage of Participants With Primary Patency
Kaplan-Meier estimate of primary patency at 30 days.
Measured: 30 Days
Percentage of Participants With Primary Patency
Kaplan-Meier estimate of primary patency at 9 months.
Measured: 9 Months
Percentage of Participants With Primary Assisted Patency
Kaplan-Meier estimate of primary assisted patency at 30 days.
Measured: 30 Days
Percentage of Participants With Primary Assisted Patency
Kaplan-Meier estimate of primary assisted patency at 9 months.
Measured: 9 Months
Percentage of Participants With Secondary Patency
Kaplan-Meier estimate of secondary patency at 30 days.
Measured: 30 Days
Percentage of Participants With Secondary Patency
Kaplan-Meier estimate of secondary patency at 9 months.
Measured: 9 Months
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 30 days.
Measured: 30 Days
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 9 months.
Measured: 9 Months
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 30 days.
Measured: 30 Days
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 9 months.
Measured: 9 Months
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 30 days.
Measured: 30 Days
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 9 months.
Measured: 9 Months
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 30 days.
Measured: 30 Days
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 9 months
Measured: 9 Months
Number of Participants With Change in Rutherford Category
Number of participants with change in Rutherford Category from pre-procedure at 30 days.
Rutherford Categories:
Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.
Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
Measured: 30 Days
Number of Participants With Change in Rutherford Category
Number of participants with change in Rutherford Category from pre-procedure at 9 months.
Rutherford Categories:
Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.
Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
Measured: 9 Months
Change in Ankle Brachial Index (ABI)
Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.
Measured: 30 Days
Change in Ankle Brachial Index (ABI)
Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.
Measured: 9 Months
Number of Participants With Change in Functional Status - EQ5D - Mobility
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Mobility) from pre-procedure at 30 days.
Measured: 30 Days
Number of Participants With Change in Functional Status - EQ5D - Mobility
Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 9 months.
Measured: 9 Months
Number of Participants With Change in Functional Status - EQ5D - Self Care
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Self Care) from pre-procedure at 30 days.
Measured: 30 Days
Number of Participants With Change in Functional Status - EQ5D - Self Care
Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 9 months.
Measured: 9 Months
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 30 days.
Measured: 30 Days
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 9 months.
Measured: 9 Months
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 30 days.
Measured: 30 Days
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 9 months.
Measured: 9 Months
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 30 days.
Measured: 30 Days
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 9 months.
Measured: 9 Months
Number of Participants With Change in Functional Status - EQ5D - Own Health State
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 30 days.
Measured: 30 Days
Number of Participants With Change in Functional Status - EQ5D - Own Health State
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 9 months.
Measured: 9 Months
Number of Participants With Improvement in Functional Status at 30 Days - Walking Improvement Questionnaire (WIQ)
Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 30 days.
Measured: 30 Days
Number of Participants With Improvement in Functional Status 9 Months - Walking Improvement Questionnaire (WIQ)
Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 9 months.
Measured: 9 Months
Percentage of Participants With Primary Patency
Kaplan-Meier estimate of primary patency at 12 months.
Measured: 12 Months
Percentage of Participants With Primary Assisted Patency
Kaplan-Meier estimate of primary assisted patency at 12 months.
Measured: 12 Months
Percentage of Participants With Secondary Patency
Kaplan-Meier estimate of secondary patency at 12 months.
Measured: 12 Months
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 12 months.
Measured: 12 Months
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 24 months.
Measured: 24 Months
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 36 months.
Measured: 36 Months
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months.
Measured: 12 Months
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 24 months.
Measured: 24 Months
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 36 months.
Measured: 36 Months
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 12 months.
Measured: 12 Months
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 24 months.
Measured: 24 Months
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 36 months.
Measured: 36 Months
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 12 months
Measured: 12 Months
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 24 months
Measured: 24 Months
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 36 months
Measured: 36 Months
Number of Participants With Change in Rutherford Category
Number of participants with change in Rutherford Category from pre-procedure at 12 months.
Rutherford Categories:
Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.
Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
Measured: 12 Months
Number of Participants With Change in Rutherford Category
Number of participants with change in Rutherford Category from pre-procedure at 24 months.
Rutherford Categories:
Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.
Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
Measured: 24 Months
Number of Participants With Change in Rutherford Category
Number of participants with change in Rutherford Category from pre-procedure at 36 months.
Rutherford Categories:
Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.
Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
Measured: 36 Months
Change in Ankle Brachial Index (ABI)
Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.
Measured: 12 Months
Change in Ankle Brachial Index (ABI)
Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.
Measured: 24 Months
Change in Ankle Brachial Index (ABI)
Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.
Measured: 36 Months
Number of Participants With Change in Functional Status - EQ5D - Mobility
Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 12 months.
Measured: 12 Months
Number of Participants With Change in Functional Status - EQ5D - Mobility
Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 24 months.
Measured: 24 Months
Number of Participants With Change in Functional Status - EQ5D - Mobility
Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 36 months.
Measured: 36 Months
Number of Participants With Change in Functional Status - EQ5D - Self Care
Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 12 months.
Measured: 12 Months
Number of Participants With Change in Functional Status - EQ5D - Self Care
Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 24 months.
Measured: 24 Months
Number of Participants With Change in Functional Status - EQ5D - Self Care
Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 36 months.
Measured: 36 Months
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 12 months.
Measured: 12 Months
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 24 months.
Measured: 24 Months
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 36 months.
Measured: 36 Months
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 12 months.
Measured: 12 Months
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 24 months.
Measured: 24 Months
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 36 months.
Measured: 36 Months
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 12 months.
Measured: 12 Months
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 24 months.
Measured: 24 Months
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 36 months.
Measured: 36 Months
Number of Participants With Change in Functional Status - EQ5D - Own Health State
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 12 months.
Measured: 12 Months
Number of Participants With Change in Functional Status - EQ5D - Own Health State
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 24 months.
Measured: 24 Months
Number of Participants With Change in Functional Status - EQ5D - Own Health State
Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 36 months.
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2016
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean Bismuth, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080871
- Sponsor's protocol ID
- BES 10-07
- Acronym
- VBXFLEX
- Status last verified
- Dec 2018
- First submitted
- 4 Mar 2014
- Last updated
- 16 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 37073512Panneton 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.
PubMed 32329658Bismuth 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.
PubMed 28697693
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02080871
- Acronym / sponsor ID
- VBXFLEX / BES 10-07
- Conditions
- Peripheral Arterial Disease
- Keywords
- PAD, Stent, Claudication, Viabahn, Gore, Endoprosthesis, Vascular Diseases, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Jul 2014 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Posted 17 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the Gore(R) VIABAHN BX for the treatment of arterial occlusive disease in the common and/or external iliac arteries.
Detailed description
This study is a prospective, multicenter, non-randomized single-arm clinical study to evaluate the safety and efficacy of the VIABAHN BX for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or external iliac arteries.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gore VIABAHN BX | Experimental | Device: Stenting of the Common and/or External Iliac ArteriesBalloon expandable stenting of iliac occlusive disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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).
Key exclusion criteria (17 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stenting of the Common and/or External Iliac ArteriesBalloon expandable stenting of iliac occlusive disease. | Device | Gore VIABAHN BX |
Primary outcome
Composite of Major Adverse Events (MAEs)
Time frame: 9 months
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.
73 secondary outcomes
Acute Procedural Success
Time frame: Discharge
30-Day Clinical Success
Time frame: 30 Days
Percentage of Participants With Primary Patency
Time frame: 30 Days
Percentage of Participants With Primary Patency
Time frame: 9 Months
Percentage of Participants With Primary Assisted Patency
Time frame: 30 Days
Percentage of Participants With Primary Assisted Patency
Time frame: 9 Months
Percentage of Participants With Secondary Patency
Time frame: 30 Days
Percentage of Participants With Secondary Patency
Time frame: 9 Months
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Time frame: 30 Days
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Time frame: 9 Months
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
Time frame: 30 Days
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
Time frame: 9 Months
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
Time frame: 30 Days
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
Time frame: 9 Months
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
Time frame: 30 Days
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
Time frame: 9 Months
Number of Participants With Change in Rutherford Category
Time frame: 30 Days
Number of Participants With Change in Rutherford Category
Time frame: 9 Months
Change in Ankle Brachial Index (ABI)
Time frame: 30 Days
Change in Ankle Brachial Index (ABI)
Time frame: 9 Months
Number of Participants With Change in Functional Status - EQ5D - Mobility
Time frame: 30 Days
Number of Participants With Change in Functional Status - EQ5D - Mobility
Time frame: 9 Months
Number of Participants With Change in Functional Status - EQ5D - Self Care
Time frame: 30 Days
Number of Participants With Change in Functional Status - EQ5D - Self Care
Time frame: 9 Months
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
Time frame: 30 Days
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
Time frame: 9 Months
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
Time frame: 30 Days
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
Time frame: 9 Months
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
Time frame: 30 Days
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
Time frame: 9 Months
Number of Participants With Change in Functional Status - EQ5D - Own Health State
Time frame: 30 Days
Number of Participants With Change in Functional Status - EQ5D - Own Health State
Time frame: 9 Months
Number of Participants With Improvement in Functional Status at 30 Days - Walking Improvement Questionnaire (WIQ)
Time frame: 30 Days
Number of Participants With Improvement in Functional Status 9 Months - Walking Improvement Questionnaire (WIQ)
Time frame: 9 Months
Percentage of Participants With Primary Patency
Time frame: 12 Months
Percentage of Participants With Primary Assisted Patency
Time frame: 12 Months
Percentage of Participants With Secondary Patency
Time frame: 12 Months
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Time frame: 12 Months
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Time frame: 24 Months
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Time frame: 36 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37073512Holden 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.
- Derived from this study: PubMed 32329658Panneton 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.
- Derived from this study: PubMed 28697693Bismuth 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.
Related trials for Peripheral Arterial Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Bismuth, MD principal investigator
The Methodist Hospital Research Institute
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stenting of the Common and/or External Iliac Arteries in people with Peripheral Arterial Disease, run by W.L.Gore & Associates at 27 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of Major Adverse Events (MAEs) (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02080871, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.