A Study of the Gore VIABAHN BX for Treatment of Occlusive Disease in the Iliac Arteries.

NCT ID: NCT02080871

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2018-10-31

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gore VIABAHN BX

Balloon expandable stenting of iliac occlusive disease

Group Type: EXPERIMENTAL

Stenting of the Common and/or External Iliac Arteries

Intervention Type: DEVICE

Balloon expandable stenting of iliac occlusive disease.

Interventions

Stenting of the Common and/or External Iliac Arteries

Balloon expandable stenting of iliac occlusive disease.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

W.L.Gore & Associates

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Bismuth, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

St. Luke's Medical Center

Phoenix, Arizona, United States

Yale University School of Medicine

New Haven, Connecticut, United States

MedStar Health Research Institute

Washington D.C., District of Columbia, United States

University of Miami

Miami, Florida, United States

Baptist Cardiac and Vascular Institute

Miami, Florida, United States

Coastal Vascular Institute

Pensacola, Florida, United States

Cardiovascular Associates

Elk Grove Village, Illinois, United States

Iowa Methodist Medical Center

West Des Moines, Iowa, United States

University of Louisville

Louisville, Kentucky, United States

Essentia Institute for Rural Health / St Mary's Hospital

Duluth, Minnesota, United States

North Memorial Heart & Vascular Institute

Plymouth, Minnesota, United States

Advanced Vascular Associates

Morristown, New Jersey, United States

Holy Name Medical Center

Teaneck, New Jersey, United States

Research Foundation SUNY Buffalo

Buffalo, New York, United States

Cornell University

New York, New York, United States

Sanford Clinic - Clinical Research

Fargo, North Dakota, United States

Ohio Health

Columbus, Ohio, United States

Holy Spirit Cardiovascular Institute

Camp Hill, Pennsylvania, United States

UPMC

Pittsburgh, Pennsylvania, United States

The Miriam Hospital

Providence, Rhode Island, United States

MUSC

Charleston, South Carolina, United States

Greenville Memorial Hospital

Greenville, South Carolina, United States

University Surgical Associates

Chattanooga, Tennessee, United States

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, United States

The Methodist Hospital

Houston, Texas, United States

Sentara Medical Group

Norfolk, Virginia, United States

Auckland City Hospital

Auckland, , New Zealand

Countries

United States; New Zealand

References

Holden A, Takele E, Hill A, Sakhuja R, Metzger C, Gray BH, Cavadino A. Long-Term Follow-up of Subjects With Iliac Occlusive Disease Treated With the Viabahn VBX Balloon-Expandable Endoprosthesis. J Endovasc Ther. 2025 Feb;32(1):68-76. doi: 10.1177/15266028231165723. Epub 2023 Apr 19.

Reference Type: DERIVED

PMID: 37073512 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32329658 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28697693 (View on PubMed)

Other Identifiers

BES 10-07

Identifier Type: -

Identifier Source: org_study_id