Bovine Early Access, Compatibility and Hemostasis Post-Market Trial to Evaluate the Safety and Effectiveness of Early Access in Patients Who Require an Arteriovenous Conduit for Hemodialysis Using the Artegraft® Collagen Vascular Graft™
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Number of Participants That Were Successfully Cannulated.
研究概览
简要总结
Bovine Early Access, Compatibility, and Hemostasis (BEACH) Trial Study is to evaluate the Safety and Effectiveness of Early Access in Patients Who Require an Arteriovenous Conduit for Hemodialysis using the Artegraft® Collagen Vascular Graft™. The objective of the BEACH Trial is to demonstrate that early access of Artegraft is associated with acceptable rates of successful early access, and acceptable rates of a composite of adverse events, to support a modification of existing device labeling stating that Artegraft is capable of cannulation within 72 hours post implantation.
详细描述
Chronic kidney disease (CKD) is a major health problem that affects approximately 26 million Americans. Many of those suffering CKD will progress to develop end stage renal disease (ESRD) and require lifelong hemodialysis (HD) to filter wastes from their blood. There are nearly 2.5 million patients who receive HD worldwide, and this population is growing at a rate of 8% per year. This projects that the worldwide HD population to reach approximately 3.4 million by the year 2020. There are over 600,000 patients on HD in the US and an estimated 100,000 new cases are reported annually. The interventions required to maintain a person on HD carry a significant financial burden, with costs estimated to be as high as $30 billion annually. Given the increasing epidemic of obesity, diabetes, and heart disease, the burden of ESRD will continue to grow, making new interventions that can improve the social, physical, and financial realities of treating ESRD essential.
A critical factor in the survival of renal dialysis patients is the surgical creation of vascular access. Despite the fistula-first initiative, many patients will start hemodialysis using a central venous catheter (CVC). This increases the risks of associated bloodstream infections, central venous stenosis, and poorer outcomes from subsequent vascular cannulations.
Arteriovenous grafts have advantages compared with central venous catheters for dialysis and guidelines suggest their use as second choice after arteriovenous fistulas. The suggested advantages of grafts over fistulas is the ability to cannulate or access the graft earlier, traditionally 2 weeks for AVG rather than 6 weeks for AVF, and the lower rates of primary failure.
Standard practice with expanded polytetrafluoroethylene (ePTFE) grafts has been to avoid cannulation for 2 weeks following placement, but new generation grafts have been marketed for their early cannulation properties allowing use as an alternative to central venous catheters for prompt access.
The proposed BEACH Trial is a multi-center, prospective clinical trial to evaluate early access of an existing, FDA-approved bovine carotid vascular graft, approved as a general peripheral vascular graft and for hemodialysis. The BEACH Trial is seeking to demonstrate that early access, defined as within 72 hours post implantation, of the Artegraft device results in acceptable clinical outcomes including ability to support dialysis needs thereby obviating the requirement for interim catheter placement or facilitating the removal of an existing catheter with acceptable composite major adverse clinical events (MACE) rate up to 26 weeks (6 months) post implant.
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
- Single (Investigator)
盲法说明
Patients will be randomized in a 2:1 ratio to either early or late vascular access. The randomization will be stratified by investigative site, and will use a random permuted block design within strata, with blocks of size 3 and 6 ordered randomly within site.
Once a patient signs informed consent, is determined to meet the inclusion/exclusion criteria, and is successfully implanted with the Artegraft, the site designated staff will open an envelope to determine the randomization number and whether the patient is randomly allocated to early or late vascular access.
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
- •Patients are eligible to be included in the study only if they meet the following criteria:
- •Male or Female, 18 years or older
- •Diagnosis of End Stage Renal Disease (ESRD) and require vascular access for hemodialysis
- •Native [autogenous tissue] AV fistula creation or access is not indicated or non-viable [disadvantaged veins]
- •Requiring repair of an existing fistula or conduit, but only if using Artegraft as an interposition placement and the Artegraft is cannulated [not the fistula]. Artegraft must be place in a fresh subcutaneous tunnel. Thigh loop grafts will not be used.
- •Able to accommodate vascular graft placement in the upper extremity (i.e., forearm, or upper arm)
- •Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)
- •Able and willing to comply with the study protocol
- •Agrees to initiate and maintain hemodialysis treatments
- •Life expectancy is > 1 year based on physician assessment
排除标准
- •Patients are excluded from the trial if any of the following criteria apply:
- •High grade central venous stenosis/occlusion
- •Breast-feeding, pregnant or planning pregnancy within next 12 months.
- •Non-resolved infected existing grafts
- •Documented sepsis/bacteremia by blood culture within 4 weeks of implantation.
- •History of non-controlled immunodeficiency syndrome, including AIDS/HIV; Active clinically significant immune-mediated disease, not controlled by low-dose maintenance immunosuppression. The diagnosis of HIV alone, provided adequately treated, is not a contraindication for enrolment.
- •Severe liver dysfunction and/or coagulation or bleeding disorders.
- •Elevated platelet count > 1 million cells/mm3
- •History of heparin-induced thrombocytopenia syndrome (HIT)
- •Documented hypercoagulable state
- •Currently participating in another investigational drug or device study which may clinically interfere with any endpoints of this trial
- •Known hypersensitivity or contraindication to device materials or procedural medications that cannot be adequately managed medically
- •History or evidence of severe cardiac disease (NYHA Functional Class III or IV), , myocardial infarction within 6 months of enrollment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina, uncontrolled CHF
- •History or evidence of severe peripheral arterial disease in the extremity selected for implant (i.e. arterial inflow insufficient to support hemodialysis)
- •History of cancer with active disease or treatment within the previous year, except for non-invasive basal or squamous cell carcinoma of the skin
- •Bleeding diathesis, other than that associated with ESRD
- •Scheduled renal transplant within 6 months
- •Patients who require chronic anticoagulation except for antiplatelet therapy. Patients currently receiving or who have received within the last month direct thrombin inhibitors, factor Xa inhibitors, or vitamin K antagonists should not be included in the study.
结局指标
主要结局
Number of Participants That Were Successfully Cannulated.
时间窗: less than 72 hours
Early access success, defined by three cannulations, the first one started within 72 hours after implantation, all with minimum dialysis flow rates of 250 ml/min pump flow rate, with a minimum 17-gauge needle.
Patients That Experienced Major Adverse Events
时间窗: Less than 6 month
A composite of major adverse clinical events (MACE) including perigraft infection, hemorrhage / hematoma, thrombosis, and pseudoaneurysm within 30 days after first cannulation \[Day 0\] in the early-access and late-access groups.
次要结局
- Removal of Catheter After Implantation (For Information Only)(Less than 6 months)
- Patients That Experience Major Adverse Events(Less than 6 months)
- Grafts That Were Patent After 30 Days(Less than 6 months)