Access Cannulation Trial II

Официальное название

A Study to Evaluate the Safety and Effectiveness of Voyager's Access Device for Patients Undergoing Routine Hemodialysis (Access Cannulation Trial II)

Обзор

This is a pivotal, interventional, prospective, single-arm, open-label, multi-site clinical investigation intended to support FDA clearance of the study device based on the safety and efficacy of the device in cannulating arteriovenous fistulas (AVFs) for hemodialysis procedures.

Подробное описание

This clinical investigation is estimated to last approximately 48-60 months, from initial participant enrollment until all data collection is complete on the final participant. After the patient has the study device implanted, they will be observed for 6 weeks as the implant site heals. The patient will be monitored for 36 months after device implantation as they undergo routine dialysis. Subjects will exit the investigation after the last visit and no device-related adverse events have been identified or are being monitored

Вмешательства

• Устройство VenaSure
  The device will be surgically implanted at the access site in subjects undergoing routine hemodialysis. The device is expected to provide a target to aid in long-term cannulation success.

Первичные конечные точки

• To demonstrate the effectiveness of the study device in facilitating cannulation of arteriovenous fistulas (AVFs) for hemodialysis. [Срок оценки: 6 months]
• To evaluate the safety of the study device. [Срок оценки: 12 months]

Вторичные конечные точки (7)

• To investigate time-related parameters surrounding the study device in facilitating hemodialysis. [Срок оценки: 12 months]
• To further evaluate the safety of the study device [Срок оценки: 12 months]
• To further evaluate the safety of the study device [Срок оценки: 12 months]
• To further evaluate the safety of the study device [Срок оценки: 6mo from approved cannulation through the device]
• To further evaluate the safety of the study device [Срок оценки: 36 months]
• To further evaluate the safety of the study device [Срок оценки: 3 months, 6 months, 12 months]
• To further evaluate the safety of the study device [Срок оценки: 4 weeks from initial implantation]

Критерии участия

Inclusion:

• The subject's AVF is deemed uncannulatable because:

• The subject's anticipated cannulation zone(s) is/are >6mm in depth from the surface of the skin to the anterior wall of the access vein as confirmed by ultrasound within 8 weeks prior to device implantation (each zone, Arterial/Pull and Venous/Push, shall be assessed independently of one another for device placement):

• Arterial/Pull Zone: \_\_\_\_\_ mm deep
• Venous/Push Zone: \_\_\_\_\_ mm deep

OR

• The subject's dialysis unit (which includes an experienced cannulator) attests that repeated cannulation is not achievable in their clinic due to one of the following:

• Failed access attempt in a fistula that was previously approved for cannulation, or
• Unable to palpate the fistula such that cannulation is not possible without patient risk.
• The access surgeon caring for the subject attests that the device is likely to be at least equivalent to other methods (such as venous transposition or suction-assisted lipectomy) that could make the AVF easier to access and reduce risk of cannulation infiltrations.
• The subject has either a radio-cephalic, brachio-cephalic or transposed brachio-basilic fistula.

Exclusion:

• The subject's access vein is >15mm in depth at either cannulation zones as measured by ultrasound within 8 weeks prior to device implantation.

• Arterial/Pull Zone: \_\_\_\_\_ mm in depth
• Venous/Push Zone: \_\_\_\_\_ mm in depth Note: these values should match inclusion criteria #1
• Both bidimensional measurements in the subject's access vein have a diameter of <4mm, taken with a tourniquet in place or through manual compression to the outflow, as measured by ultrasound within 8 weeks prior to device implantation (cannulation zone specific - one zone does not affect the other's eligibility).

• Arterial/Pull Zone: \_\_\_\_\_ x \_\_\_\_\_ mm in diameter
• Venous/Push Zone: \_\_\_\_\_ x \_\_\_\_\_ mm in diameter
• The subject has a flow rate of <550mL/min in the inflow artery proximal to the arterial anastomosis as measured by ultrasound within 8 weeks prior to device implantation.

• Flow: \_\_\_\_\_ mL/min
• The subject does NOT have a prescription to receive maintenance hemodialysis at least 2 times per week.
• The subject's life expectancy is <1 year per the Investigator.
• The subject does NOT have a signed and dated consent form.
• The AVF is a non-transposed basilic or brachial vein outflow AVF.
• The subject has high flow rates placing them at risk for heart failure and death at the discretion of the Investigator.
• The subject has a known skin infection, hypersensitive skin, skin breakdown/erosion or skin allergies at the potential implant sites.
• The subject has a known active systemic infection or positive blood cultures present.
• The subject's AVF has undergone a major revision and at the discretion of the Investigator can impact fistula viability and device placement (such as DRIL or PTFE segment insertion, banding, aneurysm repair, etc.), or the subject has had an occurrence of and/or intervention for AV access stenosis or thrombosis within the past month (excluded to avoid unnecessary placement into an AVF with a high likelihood of failure).
• The subject is <18 years of age.
• The subject plans to become pregnant prior to their potential treatment date.
• The subject has a body mass index >50kg/m2.
• The subject has a known clinically significant bleeding or coagulation disorder, including but not limited to low platelet count (<50,000), hypercoagulable state (e.g., antithrombin IE deficiency, antiphospholipid or anticardiolipin antibodies, Factor V Leiden, circulating Lupus anticoagulant, current, heparin-induced thrombocytopenia, protein C or S deficiency, history of recurrent deep vein thrombosis not related to AV access).
• The subject has an active malignancy.
• The subject has a known or suspected allergy to titanium, aluminum, or vanadium.
• The subject has had a significant cardiovascular event/intervention that makes them a poor surgical candidate such as myocardial infarction, angioplasty, or stent placement within 3 months of implantation.
• The subject has had a significant peripheral vascular disease requiring a major intervention within the previous 12 months (in the target limb).
• The subject has had a significant neurovascular event such as stroke or major intervention within the previous 12 months.
• The subject has an uncontrolled major symptomatic medical problem per the Investigator.
• The subject has a likelihood of poor protocol compliance due to mental incapacity, an inability to understand treatment instructions, or for any other reason in the opinion of the Investigator.
• The subject is currently participating in another investigational drug or device investigation that could clinically interfere with the endpoints of this investigation.
• The subject's conversion to home hemodialysis is anticipated at any point during their foreseeable participation in this investigation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 8 центров

• Trinity Research Group — Dothan
• Apex Research — Riverside
• Brigham and Women's Hospital — Boston
• Northwell Health — Hyde Park
• MUSC Health Orangeburg — Orangeburg
• Cardiothoracic and Vascular Surgeons — Austin
• Baylor Scott & White — Dallas
• Fairlawn Surgery Center — Roanoke

Идентификаторы

NCT: NCT05490225 · Access Cannulation Trial II

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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