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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02080871




Registration number
NCT02080871
Ethics application status
Date submitted
4/03/2014
Date registered
6/03/2014
Date last updated
16/01/2019

Titles & IDs
Public title
A Study of the Gore VIABAHN BX for Treatment of Occlusive Disease in the Iliac Arteries.
Scientific 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.
Secondary ID [1] 0 0
BES 10-07
Universal Trial Number (UTN)
Trial acronym
VBXFLEX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Stenting of the Common and/or External Iliac Arteries

Experimental: Gore VIABAHN BX - Balloon expandable stenting of iliac occlusive disease


Treatment: Devices: Stenting of the Common and/or External Iliac Arteries
Balloon expandable stenting of iliac occlusive disease.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of Major Adverse Events (MAEs)
Timepoint [1] 0 0
9 months
Secondary outcome [1] 0 0
Acute Procedural Success
Timepoint [1] 0 0
Discharge
Secondary outcome [2] 0 0
30-Day Clinical Success
Timepoint [2] 0 0
30 Days
Secondary outcome [3] 0 0
Percentage of Participants With Primary Patency
Timepoint [3] 0 0
30 Days
Secondary outcome [4] 0 0
Percentage of Participants With Primary Patency
Timepoint [4] 0 0
9 Months
Secondary outcome [5] 0 0
Percentage of Participants With Primary Assisted Patency
Timepoint [5] 0 0
30 Days
Secondary outcome [6] 0 0
Percentage of Participants With Primary Assisted Patency
Timepoint [6] 0 0
9 Months
Secondary outcome [7] 0 0
Percentage of Participants With Secondary Patency
Timepoint [7] 0 0
30 Days
Secondary outcome [8] 0 0
Percentage of Participants With Secondary Patency
Timepoint [8] 0 0
9 Months
Secondary outcome [9] 0 0
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Timepoint [9] 0 0
30 Days
Secondary outcome [10] 0 0
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Timepoint [10] 0 0
9 Months
Secondary outcome [11] 0 0
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
Timepoint [11] 0 0
30 Days
Secondary outcome [12] 0 0
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
Timepoint [12] 0 0
9 Months
Secondary outcome [13] 0 0
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
Timepoint [13] 0 0
30 Days
Secondary outcome [14] 0 0
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
Timepoint [14] 0 0
9 Months
Secondary outcome [15] 0 0
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
Timepoint [15] 0 0
30 Days
Secondary outcome [16] 0 0
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
Timepoint [16] 0 0
9 Months
Secondary outcome [17] 0 0
Number of Participants With Change in Rutherford Category
Timepoint [17] 0 0
30 Days
Secondary outcome [18] 0 0
Number of Participants With Change in Rutherford Category
Timepoint [18] 0 0
9 Months
Secondary outcome [19] 0 0
Change in Ankle Brachial Index (ABI)
Timepoint [19] 0 0
30 Days
Secondary outcome [20] 0 0
Change in Ankle Brachial Index (ABI)
Timepoint [20] 0 0
9 Months
Secondary outcome [21] 0 0
Number of Participants With Change in Functional Status - EQ5D - Mobility
Timepoint [21] 0 0
30 Days
Secondary outcome [22] 0 0
Number of Participants With Change in Functional Status - EQ5D - Mobility
Timepoint [22] 0 0
9 Months
Secondary outcome [23] 0 0
Number of Participants With Change in Functional Status - EQ5D - Self Care
Timepoint [23] 0 0
30 Days
Secondary outcome [24] 0 0
Number of Participants With Change in Functional Status - EQ5D - Self Care
Timepoint [24] 0 0
9 Months
Secondary outcome [25] 0 0
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
Timepoint [25] 0 0
30 Days
Secondary outcome [26] 0 0
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
Timepoint [26] 0 0
9 Months
Secondary outcome [27] 0 0
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
Timepoint [27] 0 0
30 Days
Secondary outcome [28] 0 0
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
Timepoint [28] 0 0
9 Months
Secondary outcome [29] 0 0
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
Timepoint [29] 0 0
30 Days
Secondary outcome [30] 0 0
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
Timepoint [30] 0 0
9 Months
Secondary outcome [31] 0 0
Number of Participants With Change in Functional Status - EQ5D - Own Health State
Timepoint [31] 0 0
30 Days
Secondary outcome [32] 0 0
Number of Participants With Change in Functional Status - EQ5D - Own Health State
Timepoint [32] 0 0
9 Months
Secondary outcome [33] 0 0
Number of Participants With Improvement in Functional Status at 30 Days - Walking Improvement Questionnaire (WIQ)
Timepoint [33] 0 0
30 Days
Secondary outcome [34] 0 0
Number of Participants With Improvement in Functional Status 9 Months - Walking Improvement Questionnaire (WIQ)
Timepoint [34] 0 0
9 Months
Secondary outcome [35] 0 0
Percentage of Participants With Primary Patency
Timepoint [35] 0 0
12 Months
Secondary outcome [36] 0 0
Percentage of Participants With Primary Assisted Patency
Timepoint [36] 0 0
12 Months
Secondary outcome [37] 0 0
Percentage of Participants With Secondary Patency
Timepoint [37] 0 0
12 Months
Secondary outcome [38] 0 0
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Timepoint [38] 0 0
12 Months
Secondary outcome [39] 0 0
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Timepoint [39] 0 0
24 Months
Secondary outcome [40] 0 0
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Timepoint [40] 0 0
36 Months
Secondary outcome [41] 0 0
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
Timepoint [41] 0 0
12 Months
Secondary outcome [42] 0 0
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
Timepoint [42] 0 0
24 Months
Secondary outcome [43] 0 0
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
Timepoint [43] 0 0
36 Months
Secondary outcome [44] 0 0
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
Timepoint [44] 0 0
12 Months
Secondary outcome [45] 0 0
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
Timepoint [45] 0 0
24 Months
Secondary outcome [46] 0 0
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
Timepoint [46] 0 0
36 Months
Secondary outcome [47] 0 0
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
Timepoint [47] 0 0
12 Months
Secondary outcome [48] 0 0
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
Timepoint [48] 0 0
24 Months
Secondary outcome [49] 0 0
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
Timepoint [49] 0 0
36 Months
Secondary outcome [50] 0 0
Number of Participants With Change in Rutherford Category
Timepoint [50] 0 0
12 Months
Secondary outcome [51] 0 0
Number of Participants With Change in Rutherford Category
Timepoint [51] 0 0
24 Months
Secondary outcome [52] 0 0
Number of Participants With Change in Rutherford Category
Timepoint [52] 0 0
36 Months
Secondary outcome [53] 0 0
Change in Ankle Brachial Index (ABI)
Timepoint [53] 0 0
12 Months
Secondary outcome [54] 0 0
Change in Ankle Brachial Index (ABI)
Timepoint [54] 0 0
24 Months
Secondary outcome [55] 0 0
Change in Ankle Brachial Index (ABI)
Timepoint [55] 0 0
36 Months
Secondary outcome [56] 0 0
Number of Participants With Change in Functional Status - EQ5D - Mobility
Timepoint [56] 0 0
12 Months
Secondary outcome [57] 0 0
Number of Participants With Change in Functional Status - EQ5D - Mobility
Timepoint [57] 0 0
24 Months
Secondary outcome [58] 0 0
Number of Participants With Change in Functional Status - EQ5D - Mobility
Timepoint [58] 0 0
36 Months
Secondary outcome [59] 0 0
Number of Participants With Change in Functional Status - EQ5D - Self Care
Timepoint [59] 0 0
12 Months
Secondary outcome [60] 0 0
Number of Participants With Change in Functional Status - EQ5D - Self Care
Timepoint [60] 0 0
24 Months
Secondary outcome [61] 0 0
Number of Participants With Change in Functional Status - EQ5D - Self Care
Timepoint [61] 0 0
36 Months
Secondary outcome [62] 0 0
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
Timepoint [62] 0 0
12 Months
Secondary outcome [63] 0 0
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
Timepoint [63] 0 0
24 Months
Secondary outcome [64] 0 0
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
Timepoint [64] 0 0
36 Months
Secondary outcome [65] 0 0
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
Timepoint [65] 0 0
12 Months
Secondary outcome [66] 0 0
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
Timepoint [66] 0 0
24 Months
Secondary outcome [67] 0 0
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
Timepoint [67] 0 0
36 Months
Secondary outcome [68] 0 0
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
Timepoint [68] 0 0
12 Months
Secondary outcome [69] 0 0
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
Timepoint [69] 0 0
24 Months
Secondary outcome [70] 0 0
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
Timepoint [70] 0 0
36 Months
Secondary outcome [71] 0 0
Number of Participants With Change in Functional Status - EQ5D - Own Health State
Timepoint [71] 0 0
12 Months
Secondary outcome [72] 0 0
Number of Participants With Change in Functional Status - EQ5D - Own Health State
Timepoint [72] 0 0
24 Months
Secondary outcome [73] 0 0
Number of Participants With Change in Functional Status - EQ5D - Own Health State
Timepoint [73] 0 0
36 Months

Eligibility
Key inclusion criteria
1. Patient is at least 18 years old;

2. Patient is male, infertile female, or female of childbearing potential practicing an
acceptable method of preventing pregnancy;

3. Patient or legal representative is willing to give written informed consent;

4. Patient is capable of complying with protocol requirements, including all follow-up
visits;

5. Patient has symptomatic claudication or rest pain without tissue loss (Rutherford
Categories 2-4).

6. Patient has de novo or restenotic target lesion(s) in the common and/or external iliac
artery;

7. Patient has one or more regions of stenosis = 50% in the target vessel, based on
visual estimate;

8. Patient has a target vessel diameter visually estimated to be approximately between 5
mm and 13 mm;

9. 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).

10. 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;

11. 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;

12. Patient has the device advanced across the target lesion(s) and positioned for
deployment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient has a life expectancy of less than 1 year;

2. Patient has a known allergy to stent graft components, including stainless steel or
heparin;

3. Patient has a known intolerance to antiplatelet, anticoagulant, or thrombolytic
medications that would prevent compliance with the protocol;

4. Patient has a condition (unrelated to the study) that is expected to require
indefinite, or lifelong, anticoagulation

5. Patient has an uncorrected bleeding disorder (platelet count < 80,000/µL);

6. Patient has severe chronic renal insufficiency (serum creatinine level > 2.5mg/dL) and
not on hemodialysis;

7. Patient has a known hypercoagulability that cannot be corrected;

8. Patient has evidence of a blood borne infection;

9. Patient has had vascular access/catheterization in the lower extremity within 30 days
of study enrollment;

10. 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;

11. 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;

12. Patient is currently participating in this or another investigative clinical study.

13. Patient has a stent or stent graft located within or immediately adjacent (=5mm) to
study lesion(s);

14. Patient has evidence of angiographically visible thrombus within or adjacent to the
target lesion(s);

15. Patient has aneurysmal dilation proximal or distal to the target lesion(s) that would
interfere with the placement of the device;

16. Patient has a target lesion requiring atherectomy or any ablative device to facilitate
stent delivery;

17. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2018
Sample size
Target
Accrual to date
Final
134
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Dakota
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Rhode Island
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
New Zealand
State/province [19] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
W.L.Gore & Associates
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT02080871
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jean Bismuth, MD
Address 0 0
The Methodist Hospital Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries