Percutaneous Anastomosis Creation for Hemodialysis Access
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- to assess the maturation rate of endo-Arterio venous fistula created with Wavelinq
研究概览
简要总结
The investigators propose to adult patients needing the creation of a vascular access for hemodialysis, not eligible to the creation of a distal AVF, to create a percutaneous anastomosis between an artery and a vein (endo-AVFs). The study is a prospective single-center cohort (Nice University Hospital) with a 2-year follow-up (recruitment: 18 months, length of study per patient: 24 months, data analysis: 6 months). After the procedure, patients will receive duplex-ultrasound follow-up, according to local practice, at 6 weeks (+ surgical examination), 3, 6, 12, 18 and 24 months.
详细描述
- Inclusion baseline Visit The patient is adressed by his/her nephrologist for the creation of a vascular access for hemodialysis. It is provided with a venous and arterial map of the two upper limbs (not specific to the study) as well as a blood test necessary for anesthesia.
- Inclusion visit The patient is examined by the vascular surgeon who determines, via arterial and venous mapping, and once the inclusion and non-inclusion criteria have been reviewed, whether he is eligible for the study. Participation in the protocol is then proposed to him. If he agrees to participate, the patient signs the informed consent after an appropriate time for reflection.
The anesthesia consultation and the date of the procedure are scheduled during this visit. 3. Response: V0 The patient is hospitalized in the vascular surgery department, preferably in the day surgery unit, or in the full hospitalization department if he lives too far away or cannot be accompanied.
Once in the operating room, and after anesthetic induction, the surgeon proceeds to create the percutaneous fistula. At the end of the intervention, the surgeon performs the shivering and the patient goes back to the service or remains for a while in the post-operative monitoring room depending on the anesthesia he has received.
The patient is allowed to go home the same day for UCA patients, or the next day for patients on full hospitalization; once the surgeon has verified the presence of the thrill and the absence of signs of early ischemia, characterized or hematomas.
The patient leaves with his appointment date at 6 weeks. 4. Follow-up to S6: V1
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patient referred by the nephrologist for the creation of a vascular access for hemodialysis
- •Patient eligible for the creation of an arteriovenous fistula of the upper limb further to assessment by the surgeon
- •Pre-operative venous and arterial Doppler ultrasound performed on the upper limbs, the results of which meet the following criteria for the same limb:
- •Perforating vein present and permeable, with no stenosis, measuring at least 2 mm in diameter
- •Permeable cephalic vein of the arm, rectilinear over at least 10 cm, with no stenosis, measuring at least 2.5 mm
- •Permeable ulnar and/or radial vein, with no stenosis, measuring at least 2 mm in diameter
- •Permeable ulnar and/or radial vein, with no stenosis or major calcifications, measuring at least 2 mm in diameter
- •Permeable brachial artery, with no stenosis, with no major calcifications
- •Informed consent signature (by the designated trusted person if necessary)
- •Membership of a social security system
排除标准
- •History of vascular access for hemodialysis on the same limb (except for a distal radiocephalic fistula with chronic malfunction or dialysis catheter)
- •Patients eligible for the creation of a distal vascular access, at the anatomical snuffbox or the wrist, with the following criteria:
- •Clinical examination of the upper limbs highlighting a cephalic vein at the distal 1/3 of the forearm, a radial pulse, an ulnar pulse and a negative Allen test, and
- •Pre-operative venous and arterial Doppler ultrasound performed on the upper limbs, showing:
- •a permeable cephalic vein on the forearm, with no stenosis, measuring at least 2 mm in diameter at the distal 1/3 of the forearm over a length of at least 15 cm.
- •a permeable radial artery, with no stenosis, with no major calcifications, measuring at least 2 mm in diameter at the distal 1/3 of the forearm, not dominant,
- •a permeable ulnar artery, with no stenosis nor calcifications,
- •a permeable palmar arch, functional, with no stenosis or calcifications
- •Patients treated with immunosuppressants
- •Patients having had or scheduled to have major surgery in the six weeks prior or further to inclusion
- •Patients with radial arterial and/or ulnar artery thrombosis
- •Patients with a vascular anomaly, including a target artery-vein distance that is too great or a venous or arterial thrombosis that is pre-existing or discovered on the day of the procedure, which does not permit use of the device.
- •Patients with a severe known allergy to iodinated contrast agents
- •Patients under guardianship or trusteeship
- •Patients deprived of freedom
- •Pregnant patients (women of child-bearing age will receive a urine pregnancy test to rule out pregnancy prior to inclusion, results will be given to them by the doctor of their choosing).
结局指标
主要结局
to assess the maturation rate of endo-Arterio venous fistula created with Wavelinq
时间窗: at 3 months
assessed as the ratio between the number of successful maturation of the access at 3 month and the total number of Arterio venous fistula created
次要结局
- To assess the primary patency of Arterio venous fistula created percutaneously(2 years)
- nephrologist's satisfaction.(24 months.)