Paclitaxel Coated PTA Balloons for Treatment of Dysfunctional AV Fistulae and Grafts (ACCESS)
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The purpose of this study is to evaluate the Lutonix® 035 Drug Coated Balloon PTA Catheter (CE mark) for use as intended in the treatment of subjects with clinically significant hemodialysis vascular access stenosis or occlusion.
Access circuit primary patency [ Time Frame: 6 and 12 months ]
Abandonment of permanent access in the index extremity [ Time Frame: 6 and 12 months ]
Number of interventions required to maintain target lesion patency [ Time Frame: 6 and 12 months ]
Number of interventions, required to maintain access circuit patency [ Time Frame: 6 and 12 months ]
The access circuit is defined as "the area from the AV access graft arterial anastomosis to the superior vena-cava right atrial junction." The outcome is recording all interventions that occur in the access circuit up until the time of circuit failure (patency).
Major vascular complications [ Time Frame: < or at 1 month ]
Rate of device and procedure related adverse events [ Time Frame: 1, 6 and 12 months ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age ≥18 years
The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form (ICF)
Hemodialysis access on the arm presenting with any clinical abnormalities as defined in the K/DOQI guidelines
Native AV fistula or synthetic AV graft has been implanted ≥30 days
Target de novo or non-stented restenotic lesion(s) consisting of a >50% stenosis by visual estimate. Successful treatment of non target lesion(s) (residual stenosis <30% by visual estimate) without procedural complication by standard of care
Successful predilatation of the target lesion with a percutaneous transluminal angioplasty (PTA) balloon
Intended target lesion(s) (maximum of 2) can be treated
No other prior surgical or vascular interventions within 2 weeks before and/or planned 30 days after the treatment
Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children
Known contraindication (including allergic reaction) or sensitivity to contrast media, ASA, clopidogrel, ticlopidine, paclitaxel (mild to severe cases), that cannot be adequately managed with pre-and post-procedure medication
Life expectancy <12months
Scheduled for kidney transplant or peritoneal dialysis in the next 12months;
Stent in the target treatment area
Blood coagulative disorder, sepsis, or current AV access infection
Currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study NOTE: Enrollment in another investigational drug, biologic, or device study during the follow- up period is not allowed