NCT05448950已完成不适用
Continued Access Study of the InterGraft™ Venous Anastomotic Connector for Minimally Invasive Connection of an Arteriovenous Graft for Hemodialysis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Cumulative Patency
研究概览
简要总结
The continued access study of the InterGraft Venous Anastomotic Connector (Venous InterGraft Continued Access Study, or 'VIG-CAS') allows for continued enrollment of subjects while the marketing application is being prepared and subsequently reviewed by FDA. The VIG-CAS will include the same patient population, follow-up schedule, and study endpoints as the VIG pivotal study.
详细描述
The VIG-CAS is a multicenter, prospective, single-arm study that will include up to 15 subjects contributed from up to 5 study sites that previously participated in the VIG pivotal study. No new investigators will be included. All subjects will be assigned to treatment with the VIG and a standard sutured arterial anastomosis for implantation of an arteriovenous graft (AVG) for hemodialysis. The selection criteria (patient population), follow-up schedule, and study endpoints are the same as those used in the pivotal study.
Study data will be collected up to the point at which each subject has completed the final 6-month follow up or experienced a terminal study event.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject is ≥ 18 years of age.
- •Subject requires the creation of a vascular access graft for hemodialysis, secondary to a diagnosis of End Stage Renal Disease.
- •Subject has the vascular access graft placed in an upper extremity.
- •Baseline imaging shows suitable vascular anatomy/ vessel size for the InterGraft™ Venous Connector and an artery at least 3.5 mm in diameter that is suitable for creating the arterial anastomosis.
- •Subject has a reasonable expectation of remaining on hemodialysis for at least 6 months.
- •Subject or his/her legal guardian understands the study and is willing and able to comply with the dialysis schedule and follow-up requirements.
- •Subject or his/her legal guardian provides written informed consent. NOTE: In accordance with the requirements of some Institutional Review Boards (IRBs), where applicable, only those subjects with capacity to consent for themselves will be included. Thus, where required by the IRB, adult individuals who lack capacity to consent for themselves will be excluded from the study.
- •Physician's examination at time of surgery shows no significant vessel lesions, calcification(s), anatomic structures, or abnormalities that may limit ability to safely deploy the InterGraft™ Venous Connector or create a sutured arterial anastomosis.
排除标准
- •Subject has a documented and unsuccessfully treated ipsilateral central venous stenosis as determined by imaging.
- •Subject currently has a known or suspected bacterial, fungal, or HIV infection. NOTE: Subjects with hepatitis B or C may be included in the study.
- •Subject has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin. NOTE: The intent of this criterion is to exclude patients with high risk for bleeding or clotting complications. Patients who are taking the oral anticoagulant Eliquis® (apixaban) may be included in the study if Eliquis is temporarily discontinued prior to the study procedure, in accordance with the approved prescribing instructions. Patients may receive anticoagulation therapy any time after the study AV graft implant procedure, at their physician's discretion. This should be driven by an indication unrelated to the vascular access.
- •Subject has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to heparin.
- •Subject has co-morbid conditions that may limit their ability to comply with study and follow-up requirements.
- •Subject has had >2 previous arteriovenous accesses in treatment arm.
- •Subject is currently taking Aggrenox®.
- •Subject needs or is scheduled for any major surgery within 30 days of the study procedure.
- •Subject is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone (>10 mg), cyclosporine, tacrolimus, or cyclophosphamide.
- •Life expectancy is less than 12 months.
- •Subject is pregnant. NOTE: A negative urine pregnancy test within 24 hours of the study procedure is required in all female subjects with reproductive capacity.
- •Subject is a poor compliance risk (i.e.. history of IV or oral drug abuse).
- •Subject is enrolled in another dialysis or vascular investigational study.
结局指标
主要结局
Cumulative Patency
时间窗: 6 months
Percentage of subjects free from loss of access of the AVG for hemodialysis
次要结局
- Acute Device Success(At implant)
- Primary Unassisted Patency(6 months)
- Time to First Cannulation(6 months)
- Interventions Required to Maintain Secondary Patency(6 months or up to time of early exit from the study, whichever occurs first.)
- Protocol-defined Serious Adverse Events (SAEs)(6 months or up to time of early exit from the study, whichever occurs first.)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Clinical Evaluation of a Vascular Venous Anastomotic Connector [InterGraft VIG-only Study]End Stage Renal DiseaseNCT02532621Phraxis, Inc.158
终止
3 期
Veinplicity for Improved Venous Access: The VIVA TrialDifficult-to-access Veins for Intravenous CannulationNCT03752632Physeon GmbH120
已完成
3 期
Ethanol Lock Therapy for Treatment and Secondary Prophylaxis of Central Line-Associated Bloodstream InfectionCentral Line-Associated Bloodstream InfectionNCT01472965St. Jude Children's Research Hospital95
已完成
不适用
Two is Better Than One: A Novel Venous Access System for Intermittent ApheresisApheresisNCT04846374University of North Carolina, Chapel Hill20
已完成
不适用
Ultrasound Guided Axillary Venous Cannulation in PediatricsUltrasound Guided Central Venous CannulationNCT02806401Seoul National University Hospital132