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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01961167




Registration number
NCT01961167
Ethics application status
Date submitted
8/10/2013
Date registered
11/10/2013
Date last updated
19/11/2019

Titles & IDs
Public title
Evaluation of the GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (VIABAHN BX)
Scientific title
Evaluation of the GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (VIABAHN BX) for the Treatment of Occlusive Disease in the Common and External Iliac Arteries
Secondary ID [1] 0 0
VBX 13-05
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Common Iliac Artery Occlusive Disease 0 0
External Iliac Artery Occlusive Disease 0 0
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 common and/or external iliacs

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


Treatment: Devices: Stenting of common and/or external iliacs
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
30 days
Secondary outcome [1] 0 0
Acute Procedural Success
Timepoint [1] 0 0
Discharge
Secondary outcome [2] 0 0
Thirty-day Clinical Success
Timepoint [2] 0 0
30 Days
Secondary outcome [3] 0 0
Primary Patency
Timepoint [3] 0 0
30 Days
Secondary outcome [4] 0 0
Primary Patency
Timepoint [4] 0 0
6 Months
Secondary outcome [5] 0 0
Primary Assisted Patency
Timepoint [5] 0 0
30 Days
Secondary outcome [6] 0 0
Primary Assisted Patency
Timepoint [6] 0 0
6 Months
Secondary outcome [7] 0 0
Secondary Patency
Timepoint [7] 0 0
30 Days
Secondary outcome [8] 0 0
Secondary Patency
Timepoint [8] 0 0
6 Months
Secondary outcome [9] 0 0
Freedom From Target Lesion(s) Revascularization (TLR)
Timepoint [9] 0 0
30 Days
Secondary outcome [10] 0 0
Freedom From Target Lesion(s) Revascularization (TLR)
Timepoint [10] 0 0
6 Months
Secondary outcome [11] 0 0
Freedom From Target Vessel Revascularization (TVR)
Timepoint [11] 0 0
30 Days
Secondary outcome [12] 0 0
Freedom From Target Vessel Revascularization (TVR)
Timepoint [12] 0 0
6 Months
Secondary outcome [13] 0 0
Number of Participants With a Change in Rutherford Category
Timepoint [13] 0 0
30 Days
Secondary outcome [14] 0 0
Number of Participants With Change in Rutherford Category
Timepoint [14] 0 0
6 Months
Secondary outcome [15] 0 0
Change in Ankle Brachial Index (ABI)
Timepoint [15] 0 0
30 Days
Secondary outcome [16] 0 0
Change in Ankle Brachial Index (ABI)
Timepoint [16] 0 0
6 Months
Secondary outcome [17] 0 0
Freedom From Major Adverse Events (MAEs)
Timepoint [17] 0 0
6 months
Secondary outcome [18] 0 0
Change in Functional Status - EQ5D- Mobility
Timepoint [18] 0 0
30 days
Secondary outcome [19] 0 0
Change in Functional Status - EQ5D- Mobility
Timepoint [19] 0 0
6 Months
Secondary outcome [20] 0 0
Change in Functional Status - EQ5D - Self Care
Timepoint [20] 0 0
30 days
Secondary outcome [21] 0 0
Change in Functional Status - EQ5D - Self Care
Timepoint [21] 0 0
6 Months
Secondary outcome [22] 0 0
Change in Functional Status - EQ5D - Usual Activities
Timepoint [22] 0 0
30 days
Secondary outcome [23] 0 0
Change in Functional Status - EQ5D - Usual Activities
Timepoint [23] 0 0
6 Months
Secondary outcome [24] 0 0
Change in Functional Status - EQ5D - Pain/Discomfort
Timepoint [24] 0 0
30 Days
Secondary outcome [25] 0 0
Change in Functional Status - EQ5D - Pain/Discomfort
Timepoint [25] 0 0
6 Months
Secondary outcome [26] 0 0
Change in Functional Status - EQ5D - Anxiety/Depression
Timepoint [26] 0 0
30 Days
Secondary outcome [27] 0 0
Change in Functional Status - EQ5D - Anxiety/Depression
Timepoint [27] 0 0
6 Months
Secondary outcome [28] 0 0
Change in Functional Status - EQ5D- Own Health State
Timepoint [28] 0 0
30 Days
Secondary outcome [29] 0 0
Change in Functional Status - EQ5D- Own Health State
Timepoint [29] 0 0
6 Months
Secondary outcome [30] 0 0
Number of Participants With Improvement in Differential Diagnoses at 30 Days - Walking Impairment Questionnaire (WIQ)
Timepoint [30] 0 0
30 day
Secondary outcome [31] 0 0
Number of Participants With Improvement in Differential Diagnoses at 180 Days - Walking Impairment Questionnaire (WIQ)
Timepoint [31] 0 0
6 Months

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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 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 study procedure;
* Patient is currently participating in this or another investigative clinical study.
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
1/12/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/12/2017
Sample size
Target
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 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
The primary objective of the VBX13-05 clinical study is to evaluate the safety and efficacy of 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.
Trial website
https://clinicaltrials.gov/study/NCT01961167
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Holden, MB ChB
Address 0 0
Auckland City Hospital
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01961167