Clinical trial NCT01961167: Evaluation of the GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (VIABAHN BX)
Official title: Evaluation of the GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (VIABAHN BX) for the Treatment of Occlusive Disease in the Common and External Iliac Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Iliac Artery Occlusive Disease
External Iliac Artery Occlusive Disease
Peripheral Arterial Disease
Keywords: PAD
Stent
Claudication
VIABAHN
Gore
Endoprosthesis
Vascular Diseases
Cardiovascular Diseases
Iliac Occlusive Disease
Balloon Expandable
Stent Graft
VBX
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2013-10-11
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group assignment
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Composite of Major Adverse Events (MAEs)
timeFrame: 30 days
Secondary outcomes:
measure: Acute Procedural Success
timeFrame: Discharge
measure: Thirty-day Clinical Success
timeFrame: 30 Days
measure: Primary Patency
timeFrame: 30 Days
measure: Primary Patency
timeFrame: 6 Months
measure: Primary Assisted Patency
timeFrame: 30 Days
measure: Primary Assisted Patency
timeFrame: 6 Months
measure: Secondary Patency
timeFrame: 30 Days
measure: Secondary Patency
timeFrame: 6 Months
measure: Freedom From Target Lesion(s) Revascularization (TLR)
timeFrame: 30 Days
measure: Freedom From Target Lesion(s) Revascularization (TLR)
timeFrame: 6 Months
measure: Freedom From Target Vessel Revascularization (TVR)
timeFrame: 30 Days
measure: Freedom From Target Vessel Revascularization (TVR)
timeFrame: 6 Months
measure: Number of Participants With a Change in Rutherford Category
timeFrame: 30 Days
measure: Number of Participants With Change in Rutherford Category
timeFrame: 6 Months
measure: Change in Ankle Brachial Index (ABI)
timeFrame: 30 Days
measure: Change in Ankle Brachial Index (ABI)
timeFrame: 6 Months
measure: Freedom From Major Adverse Events (MAEs)
timeFrame: 6 months
measure: Change in Functional Status - EQ5D- Mobility
timeFrame: 30 days
measure: Change in Functional Status - EQ5D- Mobility
timeFrame: 6 Months
measure: Change in Functional Status - EQ5D - Self Care
timeFrame: 30 days
measure: Change in Functional Status - EQ5D - Self Care
timeFrame: 6 Months
measure: Change in Functional Status - EQ5D - Usual Activities
timeFrame: 30 days
measure: Change in Functional Status - EQ5D - Usual Activities
timeFrame: 6 Months
measure: Change in Functional Status - EQ5D - Pain/Discomfort
timeFrame: 30 Days
measure: Change in Functional Status - EQ5D - Pain/Discomfort
timeFrame: 6 Months
measure: Change in Functional Status - EQ5D - Anxiety/Depression
timeFrame: 30 Days
measure: Change in Functional Status - EQ5D - Anxiety/Depression
timeFrame: 6 Months
measure: Change in Functional Status - EQ5D- Own Health State
timeFrame: 30 Days
measure: Change in Functional Status - EQ5D- Own Health State
timeFrame: 6 Months
measure: Number of Participants With Improvement in Differential Diagnoses at 30 Days - Walking Impairment Questionnaire (WIQ)
timeFrame: 30 day
measure: Number of Participants With Improvement in Differential Diagnoses at 180 Days - Walking Impairment Questionnaire (WIQ)
timeFrame: 6 Months
Other outcomes:
measure: Device or Procedure-related Death
timeFrame: 30 Days
measure: Freedom From Myocardial Infarction (MI)
timeFrame: 30 Days
measure: Freedom From Major Amputation of the Treated Leg(s)
timeFrame: 6 Months
Locations:
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
affiliation: Auckland City Hospital
name: Andrew Holden, MB ChB
role: PRINCIPAL_INVESTIGATOR
References: