NCT02363972已完成不适用
Ellipsys Vascular Access Catheter System Clinical Trial
Medtronic Endovascular10 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2015年2月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 10
- 主要终点
- Maturation Success Rate at 90 Days
研究概览
简要总结
A prospective single-arm well-controlled study to evaluate the safety and effectiveness of a less invasive means of establishing vascular access to facilitate dialysis in patients with end stage renal disease.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were eligible for enrollment into the study if they met the following criteria:
- •Patients ≥ 18 years of age and ≤ 80 years of age
- •Male or non-pregnant female (verified with a urine/blood pregnancy test, for women of reproductive potential)
- •Life expectancy of at least one year, per the investigator's opinion
- •Diagnosed with end-stage renal disease (ESRD) or chronic kidney disease requiring dialysis or anticipated start of dialysis within 6 months of enrollment
- •Patients deemed medically eligible for upper extremity autogenous AV fistula creation, per institutional guidelines and/or clinical judgment
- •Adequate quality vein based on pre-operative assessment
- •Adjacent vein diameter of ≥ 2.0 mm at target anastomosis site
- •Confirmed clinically significant outflow
- •Adequate quality radial artery based on pre-operative assessment
- •a. Arterial lumen diameter of ≥ 2.0 mm at target anastomosis site
- •Adequate collateral arterial perfusion
- •Patent palmar arch
- •Negative Allen's Test for ulnar artery insufficiency
- •No clinical evidence of subclavian artery stenosis on the ipsilateral side.
- •Radial artery-adjacent vein proximity ≤ 1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedure
- •Patient was able to provide written informed consent
- •Able to travel to enrolling institution for follow-up examinations
- •Able and willing to follow a daily aspirin and/or other anti-coagulation/antiplatelet regimen, not including warfarin (Coumadin, or comparable anti-coagulant, see
排除标准
- •Exclusion Criteria:
- •Patients were excluded if any of the following was true:
- •Documented or suspected central venous stenosis including upper extremity arterial stenosis (≥ 50%)
- •a. Prior vascular surgery at or proximal (central) to the AVF target site b. Prior axillary dissection or mastectomy on the ipsilateral side as intended AV fistula site
- •History of steal syndrome from a previous hemodialysis vascular access on the ipsilateral side which required intervention or abandonment
- •Evidence of vascular disease at the radial artery/adjacent vein site on the ipsilateral side
- •Pre-existing vascular disease that could confound the study results
- •Systolic pressures < 100 mm Hg at the time of screening
- •Suspected or confirmed skin disease at the skin entry site
- •Immunocompromised patients (e.g. HIV positive)
- •Edema of the upper extremity on the ipsilateral side
- •Patients requiring immunosuppressant therapy such as sirolimus (Rapamune®) or Prednisone at a dose of > 10 mg per day
- •Peripheral white blood cell count < 1.5 K/mm3 or platelet count < 75,000 cells/mm3
- •Current diagnosis of carcinoma (defined as in remission < 1 year)
- •Pregnant or currently breast feeding
- •Known bleeding diathesis or coagulation disorder
- •Receiving warfarin (Coumadin, or comparable anti-coagulant) therapy
- •Patients with acute or active infection
- •Scheduled kidney transplant within 6 months of enrollment
- •Participation in another clinical investigation (excluding retrospective studies or studies not requiring a consent form)
- •History of substance abuse or anticipated to be non-compliant with medical care or study requirements based on investigator judgment
- •Patient required creation of an arteriovenous fistula distal to the wrist
- •Patient required nerve block requiring immobilization of the arm
结局指标
主要结局
Maturation Success Rate at 90 Days
时间窗: 90 days
Maturation success rate of the access site was a binary endpoint defined as (1) achievement of a venous diameter of greater than or equal to 4 mm and (2) blood flow greater than or equal to 500 ml/min as measured via duplex ultrasound at the 90 day follow-up visit for the ITT population.
Number of Participants With Device-related Serious Adverse Events
时间窗: 90 days
The primary safety endpoint was defined as the percent of subjects having one or more of the following device-related serious adverse events: vessel perforation, vessel dissection, and electrical shock during index; and significant embolization in a previously uninvolved arterial territory within 90 days of the index procedure.
次要结局
- Percent of Access Sites That Achieved or Maintained Maturation at 90 Days(90 days)
- Percent of Access Sites That Were Patent Following Intervention(90 days)
- Intervention Rate(90 days)
- Percent of Access Sites That Achieved Maturation Without Intervention(90 days)
- Percent of Participants With Access Systems That Successfully Created an AVF(90 days)
- Percent of Access Sites That Sustain 2-needle Cannulation by 90 Days(90 days)
- Percent of Access Sites With Clinical Patency at Discharge(90 days)
- Percent of Access Sites That Achieved Patency Without Intervention(90 days)
- Transposition Rate(90 days)
研究者
研究点 (10)
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