Clinical trial NCT02080871: A Study of the Gore VIABAHN BX for Treatment of Occlusive Disease in the Iliac Arteries.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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: 2014-03-06
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Composite of Major Adverse Events (MAEs)
timeFrame: 9 months
Secondary outcomes:
measure: Acute Procedural Success
timeFrame: Discharge
measure: 30-Day Clinical Success
timeFrame: 30 Days
measure: Percentage of Participants With Primary Patency
timeFrame: 30 Days
measure: Percentage of Participants With Primary Patency
timeFrame: 9 Months
measure: Percentage of Participants With Primary Assisted Patency
timeFrame: 30 Days
measure: Percentage of Participants With Primary Assisted Patency
timeFrame: 9 Months
measure: Percentage of Participants With Secondary Patency
timeFrame: 30 Days
measure: Percentage of Participants With Secondary Patency
timeFrame: 9 Months
measure: Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
timeFrame: 30 Days
measure: Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
timeFrame: 9 Months
measure: Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
timeFrame: 30 Days
measure: Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
timeFrame: 9 Months
measure: Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
timeFrame: 30 Days
measure: Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
timeFrame: 9 Months
measure: Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
timeFrame: 30 Days
measure: Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
timeFrame: 9 Months
measure: Number of Participants With Change in Rutherford Category
timeFrame: 30 Days
measure: Number of Participants With Change in Rutherford Category
timeFrame: 9 Months
measure: Change in Ankle Brachial Index (ABI)
timeFrame: 30 Days
measure: Change in Ankle Brachial Index (ABI)
timeFrame: 9 Months
measure: Number of Participants With Change in Functional Status - EQ5D - Mobility
timeFrame: 30 Days
measure: Number of Participants With Change in Functional Status - EQ5D - Mobility
timeFrame: 9 Months
measure: Number of Participants With Change in Functional Status - EQ5D - Self Care
timeFrame: 30 Days
measure: Number of Participants With Change in Functional Status - EQ5D - Self Care
timeFrame: 9 Months
measure: Number of Participants With Change in Functional Status - EQ5D - Usual Activities
timeFrame: 30 Days
measure: Number of Participants With Change in Functional Status - EQ5D - Usual Activities
timeFrame: 9 Months
measure: Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
timeFrame: 30 Days
measure: Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
timeFrame: 9 Months
measure: Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
timeFrame: 30 Days
measure: Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
timeFrame: 9 Months
measure: Number of Participants With Change in Functional Status - EQ5D - Own Health State
timeFrame: 30 Days
measure: Number of Participants With Change in Functional Status - EQ5D - Own Health State
timeFrame: 9 Months
measure: Number of Participants With Improvement in Functional Status at 30 Days - Walking Improvement Questionnaire (WIQ)
timeFrame: 30 Days
measure: Number of Participants With Improvement in Functional Status 9 Months - Walking Improvement Questionnaire (WIQ)
timeFrame: 9 Months
measure: Percentage of Participants With Primary Patency
timeFrame: 12 Months
measure: Percentage of Participants With Primary Assisted Patency
timeFrame: 12 Months
measure: Percentage of Participants With Secondary Patency
timeFrame: 12 Months
measure: Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
timeFrame: 12 Months
measure: Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
timeFrame: 24 Months
measure: Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
timeFrame: 36 Months
measure: Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
timeFrame: 12 Months
measure: Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
timeFrame: 24 Months
measure: Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
timeFrame: 36 Months
measure: Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
timeFrame: 12 Months
measure: Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
timeFrame: 24 Months
measure: Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
timeFrame: 36 Months
measure: Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
timeFrame: 12 Months
measure: Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
timeFrame: 24 Months
measure: Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
timeFrame: 36 Months
measure: Number of Participants With Change in Rutherford Category
timeFrame: 12 Months
measure: Number of Participants With Change in Rutherford Category
timeFrame: 24 Months
measure: Number of Participants With Change in Rutherford Category
timeFrame: 36 Months
measure: Change in Ankle Brachial Index (ABI)
timeFrame: 12 Months
measure: Change in Ankle Brachial Index (ABI)
timeFrame: 24 Months
measure: Change in Ankle Brachial Index (ABI)
timeFrame: 36 Months
measure: Number of Participants With Change in Functional Status - EQ5D - Mobility
timeFrame: 12 Months
measure: Number of Participants With Change in Functional Status - EQ5D - Mobility
timeFrame: 24 Months
measure: Number of Participants With Change in Functional Status - EQ5D - Mobility
timeFrame: 36 Months
measure: Number of Participants With Change in Functional Status - EQ5D - Self Care
timeFrame: 12 Months
measure: Number of Participants With Change in Functional Status - EQ5D - Self Care
timeFrame: 24 Months
measure: Number of Participants With Change in Functional Status - EQ5D - Self Care
timeFrame: 36 Months
measure: Number of Participants With Change in Functional Status - EQ5D - Usual Activities
timeFrame: 12 Months
measure: Number of Participants With Change in Functional Status - EQ5D - Usual Activities
timeFrame: 24 Months
measure: Number of Participants With Change in Functional Status - EQ5D - Usual Activities
timeFrame: 36 Months
measure: Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
timeFrame: 12 Months
measure: Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
timeFrame: 24 Months
measure: Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
timeFrame: 36 Months
measure: Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
timeFrame: 12 Months
measure: Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
timeFrame: 24 Months
measure: Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
timeFrame: 36 Months
measure: Number of Participants With Change in Functional Status - EQ5D - Own Health State
timeFrame: 12 Months
measure: Number of Participants With Change in Functional Status - EQ5D - Own Health State
timeFrame: 24 Months
measure: Number of Participants With Change in Functional Status - EQ5D - Own Health State
timeFrame: 36 Months
Other outcomes:
measure: Device or Procedure-related Death
timeFrame: 30 Days
measure: Myocardial Infarction (MI)
timeFrame: 30 Days
measure: Target Lesion Revascularization (TLR)
timeFrame: 9 Months
measure: Major Amputation
timeFrame: 9 Months
Locations:
city: Phoenix
country: United States
facility: St. Luke's Medical Center
state: Arizona
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Washington
country: United States
facility: MedStar Health Research Institute
state: District of Columbia
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: Baptist Cardiac and Vascular Institute
state: Florida
city: Pensacola
country: United States
facility: Coastal Vascular Institute
state: Florida
city: Elk Grove Village
country: United States
facility: Cardiovascular Associates
state: Illinois
city: West Des Moines
country: United States
facility: Iowa Methodist Medical Center
state: Iowa
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Duluth
country: United States
facility: Essentia Institute for Rural Health / St Mary's Hospital
state: Minnesota
city: Plymouth
country: United States
facility: North Memorial Heart & Vascular Institute
state: Minnesota
city: Morristown
country: United States
facility: Advanced Vascular Associates
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Research Foundation SUNY Buffalo
state: New York
city: New York
country: United States
facility: Cornell University
state: New York
city: Fargo
country: United States
facility: Sanford Clinic - Clinical Research
state: North Dakota
city: Columbus
country: United States
facility: Ohio Health
state: Ohio
city: Camp Hill
country: United States
facility: Holy Spirit Cardiovascular Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Charleston
country: United States
facility: MUSC
state: South Carolina
city: Greenville
country: United States
facility: Greenville Memorial Hospital
state: South Carolina
city: Chattanooga
country: United States
facility: University Surgical Associates
state: Tennessee
city: Kingsport
country: United States
facility: Wellmont Holston Valley Medical Center
state: Tennessee
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Norfolk
country: United States
facility: Sentara Medical Group
state: Virginia
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Jean Bismuth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Panneton 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.
citation: Bismuth 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.