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

Completed · Not applicable

Conditions studied: Peripheral Arterial Disease

In brief

Evaluation of the Gore(R) VIABAHN BX for the treatment of arterial occlusive disease in the common and/or external iliac arteries.

Key facts

Study ID: NCT02080871
Run by: W.L.Gore & Associates
People needed: 134
Starts: 2014-07-01
Expected to finish: 2018-10-01
Last updated by the study team: 2019-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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;
Patient has one or more regions of stenosis ≥ 50% in the target vessel, based on visual estimate;
Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm;
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).
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;
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;
Patient has the device advanced across the target lesion(s) and positioned for deployment.

You may not qualify if…

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 an uncorrected bleeding disorder (platelet count < 80,000/µL);
Patient has severe chronic renal insufficiency (serum creatinine level > 2.5mg/dL) and not on hemodialysis;
Patient has a known hypercoagulability that cannot be corrected;
Patient has evidence of a blood borne infection;
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 index procedure;
Patient is currently participating in this or another investigative clinical study.
Patient has a stent or stent graft located within or immediately adjacent (≤5mm) to study lesion(s);
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.

Where it is running

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

Full record on ClinicalTrials.gov

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