| Eligibility |
Inclusion:
AVF is uncannulatable* in upper arm or forearm per the attending nephrologist and
independent cannulation specialist, and has been referred for vascular access.
1. *AVF is deemed 'uncannulatable' if at least one of the following apply:
- Three or more failed access attempts within a 2-week time period.
- The fistula cannot be palpated to locate and define its margins.
- The fistula is only cannulatable in a segment that is too short to appropriately
accommodate two needles.
- Vessel is too tortuous to be cannulated adequately to accommodate needle.
- The fistula is only cannulatable (i.e. <6mm deep) in a segment that is too short
(i.e. < 5cm) to allow adequate separation of arterial and venous cannulas without
recirculation. Even though it should be cannulatable, the segment is too short.
- Aneurysm is in the only area for access because the rest of the fistula is not
accessible.
2. The subject's depth of the anterior surface of the access vein at each planned
implantation site is between 4-15mm as measured by ultrasound within 8 weeks prior to
Ark implantation.
3. The subject's fistula diameter at each planned implantation site is =5mm as measured
by ultrasound within 8 weeks prior to Ark implantation.
4. The subject does not have clinically significant flow abnormalities and they have an
AVF flow =500 mL/min as measured by ultrasound within 8 weeks prior to Ark
implantation.
5. The subject has either a radio-cephalic, brachio-cephalic or transposed
brachio-basilic fistula.
6. The subject has a prescription to receive maintenance hemodialysis at least 2 times
per week.
7. The subject's planned cannulation technique is either rope-ladder or buttonhole.
8. The subject's life expectancy is =1 year per the Investigator.
9. The subject must have signed and dated the 753-016-2001 Informed Consent Form.
Exclusion:
1. The AVF is a non-transposed basilic or brachial vein outflow AVF.
2. The subject has high flow rates placing them at risk for heart failure and death at
the discretion of the Investigator.
3. The subject has a known skin infection, hypersensitive skin, skin breakdown/erosion or
skin allergies at the potential implant sites.
4. The subject has a known active systemic infection or positive blood cultures present.
5. The subject's AVF has undergone a major revision and at the discretion of the
Investigator can impact fistula viability and Ark 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 high likelihood of
failure).
6. The subject is <18 years of age.
7. The subject plans to become pregnant prior to their potential treatment date.
8. The subject has a body mass index >50kg/m2.
9. 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).
10. The subject has an active malignancy.
11. The subject has a known or suspected allergy to titanium, aluminum, or vanadium.
12. 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.
13. The subject has had a significant peripheral vascular disease requiring a major
intervention within the previous 12 months.
14. The subject has had a significant neurovascular event such as stroke or major
intervention within the previous 12 months.
15. The subject has an uncontrolled major symptomatic medical problem per the
Investigator.
16. 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.
17. The subject is currently participating in another investigational drug or device
investigation that could clinically interfere with the endpoints of this
investigation.
18. The subject's conversion to home hemodialysis is anticipated at any point during their
foreseeable participation this investigation.
19. The subject has long dialysis vintage, is elderly, has diabetic nephropathy, severe
atherosclerosis and/or extensive vascular calcification, and in the opinion of the
Investigator should be excluded due to concern of the integrity of the implant and its
attachment to the blood vessel wall in the subject.
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