背景:对于主动脉髂动脉闭塞性疾病患者使用和选择覆膜支架的建议是有限的。
目的:GOREVBXFORWARD临床研究旨在证明GOREVIABAHNVBX球囊可扩张内假体(VBX装置)与裸金属支架(BMS)相比,在治疗复杂髂动脉闭塞性疾病方面具有优势。
方法:前瞻性,多中心,美国的随机对照研究,欧洲联盟,英国,澳大利亚,新西兰将招募有症状的患者,复杂髂动脉闭塞性疾病。在这项研究中,髂动脉闭塞性疾病定义为单侧或双侧疾病,单发或多发病变(狭窄>50%或慢性完全闭塞),长度在4至11厘米之间。为了更紧密地匹配现实世界的实践,包括轻微组织丢失的患者(卢瑟福5级)和需要血液透析的患者.将进行基线主动脉血管造影以评估目标病变特征并确定最终患者的资格。一旦患者被确认并且导丝在目标病变上就位,患者将以1:1的方式随机接受VBX装置或BMS治疗.BMS可以是球囊扩张或自扩张的,并且必须被批准用于髂动脉闭塞性疾病的适应症。患者,独立的核心实验室审核员,和临床事件委员会成员将从指定的治疗中失明。手术后至少3个月需要双重抗血栓药物治疗。主要终点是12个月的主要通畅性,将由独立的成像核心实验室和临床事件委员会裁决。关键的次要终点将进行优势测试,包括技术,急性程序,和临床成功率;踝臂指数的变化;患者生活质量;原发性通畅性;免于再狭窄;原发性辅助通畅性;继发性通畅性;免于靶病变血运重建;累积再干预率;无截肢生存率;生存率;以及卢瑟福类别的变化。研究随访将持续5年。
结果:研究完成后将报告结果。预计招生将于2023年10月开始。
结论:这项研究的结果将提供明确的,1级临床证据,为临床医生选择用于治疗复杂髂动脉闭塞性疾病的最佳支架装置提供依据。FORWARD研究具有优越性,只包括复杂的,单边,或双侧病变累及髂总动脉或髂外动脉。这项研究是一项涉及血管外科的多学科研究,介入心脏病学,和多个国家的介入放射学,对终点进行盲化核心实验室审查,希望结果将被广泛接受,并纳入复杂髂动脉闭塞性疾病患者最佳治疗的实践指南。
背景:ClinicalTrials.govNCT05811364;https://clinicaltrials.gov/study/NCT05811364。
■PRR1-10.2196/51480。
BACKGROUND: The recommendations for the use of and selection of covered stent grafts in patients with aortoiliac occlusive disease are limited.
OBJECTIVE: The GORE VBX
FORWARD clinical study aims to demonstrate the superiority of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX device) for primary patency when compared to bare metal stenting (BMS) for the treatment of complex iliac artery occlusive disease.
METHODS: A prospective, multicenter, randomized control study in the United States, European Union, United Kingdom, Australia, and New Zealand will enroll patients with symptomatic, complex iliac artery occlusive disease. In this study, iliac artery occlusive disease is defined as a unilateral or bilateral disease with single or multiple lesions (with >50% stenosis or chronic total occlusion) each between 4 and 11 cm in length. In an attempt to more closely match real-world practices, patients with minor tissue loss (Rutherford class 5) and patients requiring hemodialysis will be included. Baseline aortoiliac angiography will be performed to assess target lesion characteristics and determine final patient eligibility. Once the patient is confirmed and guidewires are in place across the target lesions, the patient will be randomized in a 1:1 format to treatment with either the VBX device or a BMS. The BMS can be balloon- or self-expanding and must be approved for the iliac artery occlusive disease indication. Patients, the independent core laboratory reviewers, and Clinical Events Committee members will be blinded from the assigned treatment. Dual antithrombotic medical therapy is required through a minimum of 3 months post procedure. The primary end point is 12‑month primary patency and will be adjudicated by an independent imaging core laboratory and Clinical Events Committee. Key secondary end points will be tested for superiority and include technical, acute procedural, and clinical success; changes in Ankle-brachial index; patient quality of life; primary patency; freedom from restenosis; primary-assisted patency; secondary patency; freedom from target lesion revascularizations; cumulative reintervention rate; amputation-free survival; survival; and change in Rutherford category. Study follow-up will continue through 5 years.
RESULTS: Outcomes will be reported following study completion. Enrollment is anticipated to start in October 2023.
CONCLUSIONS: The results of this study will provide definitive, level 1 clinical evidence to clinicians on the optimal choice of stent device to use for the treatment of complex iliac artery occlusive disease. The
FORWARD study is powered for superiority and includes only complex, unilateral, or bilateral lesions involving the common or external iliac arteries. This study is a multidisciplinary endeavor involving vascular surgery, interventional cardiology, and interventional radiology across multiple countries with a blinded core laboratory review of end points in hopes that the outcomes will be widely accepted and incorporated into practice guidelines for optimal treatment of patients with complex iliac artery occlusive disease.
BACKGROUND: ClinicalTrials.gov NCT05811364; https://clinicaltrials.gov/study/NCT05811364.
UNASSIGNED: PRR1-10.2196/51480.