The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease

Обзор

The objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.

Вмешательства

• Устройство Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
  Treatment of target lesions in the common and/or external iliac arteries by stenting with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis.
• Устройство Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent
  Treatment of target lesions in the common and/or external iliac arteries by stenting with a commercially available bare metal stent that is approved for treatment of the disease.

Первичные конечные точки

• Primary Patency [Срок оценки: 1 year]

Вторичные конечные точки (12)

• Technical success [Срок оценки: at the procedure]
• Acute procedural success [Срок оценки: at the procedure]
• Clinical success [Срок оценки: Through 1 month]
• Hemodynamic Status [Срок оценки: Through 5 years]
• Change in EQ-5D-5L [Срок оценки: Through 5 years]
• Change in WIQ [Срок оценки: Through 5 years]
• Primary patency [Срок оценки: Through 5 years]
• Freedom from binary restenosis [Срок оценки: Through 5 years]
• Primary assisted patency [Срок оценки: Through 5 years]
• Secondary patency [Срок оценки: Through 5 years]
• Freedom from target lesion revascularization [Срок оценки: Through 5 years]
• Cumulative reintervention rate [Срок оценки: Through 5 years]

Критерии участия

Критерии включения

• Age ≥ 18 years at time of informed consent signature
• Informed Consent Form (ICF) is signed by the subject
• Subject can comply with protocol requirements, including follow-up
• Patient has symptomatic claudication, rest pain, or minor tissue loss (Rutherford Category 2-5)
• Patient has de novo or restenotic lesion(s) found in the common and/or external iliac artery(ies)
• Patient has: Unilateral or bilateral single or multiple lesions (>50% stenosis or chronic total occlusion) each between 4 and 11 cm in length
• Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm
• Patient has a sufficient (<50% stenotic) common femoral artery and at least one sufficient (<50% stenotic) femoral artery (deep or superficial).
• Patient has at least one sufficient (<50% stenotic) infrapopliteal run-off vessel.

Критерии исключения

• Life expectancy <1 year
• Patient is pregnant at time of informed consent.
• Patient has a known allergy to stent or stent graft components (including nitinol, stainless steel, or heparin).
• Patient has severe chronic renal insufficiency (serum creatinine level > 2.5mg/dL) and not undergoing hemodialysis.
• Patient has evidence of a systemic infection.
• Patient has a known intolerance to antithrombotic medications that prevent compliance with study or control device Instructions for Use.
• Patient has had vascular catheterization of the lower extremities within 30 days of randomization (excluding diagnostic angiograms for the study procedure).
• Patient has previous stenting in the iliac arteries.
• Patient has previous surgical bypass in the target limb.
• Patient is currently participating in another investigative clinical study unless received written approval by the sponsor.
• Patient has a lesion requiring drug-coated balloon angioplasty, atherectomy, lithotripsy, or any ablative device to facilitate stent delivery.
• Patient has an abdominal aortic artery lesion or aneurysm.
• Patient has a lesion that requires stent placement within 2 cm of the inguinal ligament.
• Patient has isolated common iliac artery stenosis that can be treated with a single device (i.e., common iliac artery stenosis that does not require kissing stents or extend into the external iliac artery).
• Patient has outflow disease that requires concomitant interventions (i.e. common femoral endarterectomy or femoral / tibial revascularization).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 26 центров

• Central Arkansas Veterans Healthcare System — Little Rock
• VA Long Beach Healthcare System — Long Beach
• Denver Health and Hospital Authority — Denver
• North Suburban Medical Center — Denver
• University of Florida - Gainesville — Gainesville
• Radiology and Imaging Specialists of Lakeland — Lakeland
• University of South Florida — Tampa
• Atlanta VA Medical Center — Decatur
• … и ещё 18 центров

Германия · 4 центра

• Universitats-Herzzentrum Freiburg Bad Krozingen GmbH — Bad Krozingen
• St. Franziskus Hospital — Münster
• Krankenhaus der Barmherzigen Brüder — Regensburg
• Klinikum Stuttgart — Stuttgart

Италия · 4 центра

• Ospedale Niguarda Ca'Granda — Milan
• Ospedale Santa Maria della Misericordia — Perugia
• Azienda Complesso Ospedaliero San Filippo Neri — Roma
• Ospedale San Giovanni Molinette — Turin

Австралия · 3 центра

• Central Adelaide Local Health Network Incorporated — Adelaide
• Royal Perth Hospital — Nedlands
• Prince of Wales Hospital — Randwick

Великобритания · 3 центра

• East Kent Hospitals University NHS Foundation Trust — Canterbury
• Guy's and St Thomas', NHS Foundation Trust — London
• University Hospital Southampton NHS Foundation Trust — Southampton

Нидерланды · 2 центра

• Rijnstate Hospital — Arnhem
• Stichting Elisabeth-TweeSteden Ziekenhuis — Tilburg

Новая Зеландия · 1 центр

• Auckland City Hospital — Auckland

Публикации

• Kirkwood ML, Armstrong EJ, Ansari MM, Holden A, Reijnen MMPJ, Steinbauer M, Crannell Z, Novoa H, Phillips A, Schneider DB. FORWARD Study of GORE VIABAHN Balloon-Expandable Endoprostheses and Bare Metal Stents in the United States, European Union, United Kingdom, Australia, and New Zealand When Placed to Treat Complex Iliac Occlusive Disease: Protocol for a Randomized Superiority Trial. JMIR Res Pr PMID 38048145

Идентификаторы

NCT: NCT05811364 · VBX 22-06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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