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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P160021 / PAS001 |
| Study Name |
VBX FLEX Continued f/u Study
|
| Device Name |
GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
|
| Clinical Trial Number(s) |
NCT02080871
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Transit.Adolescent B(as adults): 18 yrs < 22 yrs,
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of this post approval study (VBX FLEX Continued Follow-Up Study) is to evaluate the long term safety and effectiveness of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis for treatment of iliac arterial occlusive disease. This study is a prospective, single-armed, multi-center follow-up of the BES 10-07 pivotal study (G120232).
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| Study Population |
The study population included symptomatic (Rutherford Category 2-4) patients with angiographic confirmation of either de novo or restenotic unilateral or bilateral occlusive disease in the common and/or external iliac arteries, with a total treated lesion length of less than or equal to 110 mm and vessel diameters between approximately 5 mm and 13 mm. Patients were included who presented with up to two discrete lesions requiring treatment, either one lesion per side for patients presenting with bilateral disease, or two lesions on the same side. All subjects could be treated with up to three GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis. Eligible patients in the study included those presenting with tortuous iliacs, severe lesion calcification, total occlusions, and those determined to need direct stenting (pre-dilatation optional) and/or kissing stent treatment at the aortic bifurcation.
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| Sample Size |
All 133 remaining subjects (7 subjects have discontinued the study) of the 140 original study subjects enrolled from 26 sites in U.S. and 1 site in New Zealand.
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| Key Study Endpoints |
Primary Endpoint:
Freedom from target lesion revascularization at 36 months.
Target lesion revascularization is defined as revascularization occurring within the treated segment(s) by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.
Secondary Endpoints:
Freedom from target vessel revascularization (TVR) at 12, 24 and 36 months.
Freedom from target lesion revascularization (TLR) at 12 and 24 months.
Primary patency at 12 months.
Primary assisted patency at 12 months.
Secondary patency at 12 months.
Change in Rutherford category from pre-procedure at 12, 24 and 36 months.
Change in resting Ankle-Brachial Index (ABI) or Toe Brachial Index (TBI) from pre-procedure at 12, 24 and 36 months.
Change in functional status from pre-procedure based on EQ-5D at 12, 24 and 36 months.
Change in functional status from pre-procedure based on Walking Impairment Questionnaire (WIQ) at 12, 24 and 36 months.
Serious adverse events at 12, 24 and 36 months.
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| Follow-up Visits and Length of Follow-up |
36 months
Annual (12, 24, 36 months)
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
140 Intent-to-treat population (134 per-protocol population)
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| Actual Number of Sites Enrolled |
27
|
| Patient Follow-up Rate |
133 (99.3%) at 30 days
107 (79.9%) at 36 months
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| Final Safety Findings |
The safety endpoint of this study is a composite of Major Adverse Events (MAEs). Key elements and findings include the following:
No device or procedure related deaths were reported within 30 days of the index procedure.
No MIs were reported within 30 days of the index procedure.
Three (3) cases of TLR were reported within 9 months of the index procedure.
No amputation above the metatarsals were reported within 9 months of the index procedure.
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| Final Effect Findings |
Key effectiveness endpoints and associated findings include the following:
Kaplan-Meier estimate of freedom from TLR (survival probability) is 91.2% at 36 months.
Kaplan-Meier estimate of freedom from clinically driven TLR (survival probability) is 98.1% at 36 months.
Kaplan-Meier estimate of freedom from TVR (survival probability) is 91.4% at 36 months.
Kaplan-Meier estimate of freedom from clinically driven TVR (survival probability) is 97.1% at 36 months.
Kaplan-Meier estimate of primary assisted patency (survival probability) is 99.0% at 12 months.
Change in Rutherford category from pre-procedure is 0.0% at 12 months, 1.0% at 24 months, and 0.0% at 36 months.
Improvement or maintenance in functional status from pre-procedure based on EQ-5D is at 87.7% at 12-months, 87.1% at 24-months, and
86.5% at 36 months
Median improvement in walking distance, walking speed, and stair climbing based on the Walking Impairment Questionnaire (WIQ) is
shown in the table below at 12, 24 and 36 months
Walking Impairment Questionnaire (WIQ)
Timepoint, months Walking Distance Walking Speed Stair Climbing
12 9 5 3
24 11 5 3
36 9 5 4
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| Study Strengths & Weaknesses |
The follow-up compliance and study deviations were within reasonable expectations.
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| Recommendations for Labeling Changes |
Additional information is available from these results that supplements information already contained in the publicly available SSED and labeling.
Therefore, labeling changes are recommended
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