NCT05811364招募中不适用
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
W.L.Gore & Associates43 个研究点 分布在 7 个国家目标入组 244 人开始时间: 2023年10月17日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 244
- 试验地点
- 43
- 主要终点
- Primary Patency
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Every effort will be made to blind subjects to the treatment device up to the 1 year follow up visit. The independent Core Lab and Clinical Events Committee (CEC) members will also be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
VBX Device Group
Active Comparator
Subject in this group will receive treatment with the GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)
干预措施: Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Device)
BMS Control Group
Active Comparator
Subjects in this group will receive treatment with a commercially available bare metal stent (BMS) that is approved for treatment of the disease
干预措施: Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent (Device)
结局指标
主要结局
Primary Patency
时间窗: 1 year
Blood flow through the target lesion (no evidence of binary restenosis \>50% or occlusion) without a Target Lesion Revascularization (TLR).
次要结局
- Change in EQ-5D-5L(Through 5 years)
- Hemodynamic Status(Through 5 years)
- Primary patency(Through 5 years)
- Primary assisted patency(Through 5 years)
- Secondary patency(Through 5 years)
- Freedom from target lesion revascularization(Through 5 years)
- Cumulative reintervention rate(Through 5 years)
- Freedom from clinically driven target lesion revascularization(Through 5 years)
- Amputation-free survival(Through 5 years)
- Change in Rutherford Category(Through 5 years)
- Technical success(at the procedure)
- Acute procedural success(at the procedure)
- Clinical success(Through 1 month)
- Change in WIQ(Through 5 years)
- Freedom from binary restenosis(Through 5 years)
- Survival(Through 5 years)
研究者
研究点 (43)
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