Paclitaxel Coated PTA Balloons for Treatment of Dysfunctional AV Fistulae and Grafts
- Conditions
- Dysfunctional AV FistulaDysfunctional AV Graft
- Interventions
- Device: Lutonix Paclitaxel Drug Coated Balloon
- Registration Number
- NCT02183194
- Lead Sponsor
- C. R. Bard
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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;
- Thrombosed access
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lutonix Paclitaxel Drug Coated Balloon Lutonix Paclitaxel Drug Coated Balloon -
- Primary Outcome Measures
Name Time Method Efficacy: Primary Patency 6 months Target Lesion Primary Patency (TLPP): The interval following index procedure intervention until the next reintervention of the target lesion or access thrombosis.
- Secondary Outcome Measures
Name Time Method Target Lesion Primary Patency (TLPP) 12 months Access circuit primary patency 6 and 12 months Abandonment of permanent access in the index extremity 6 and 12 months Number of interventions required to maintain target lesion patency 6 and 12 months Number of interventions, required to maintain access circuit patency 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 < or at 1 month Rate of device and procedure related adverse events 1, 6 and 12 months
Trial Locations
- Locations (4)
LKH-Univ. Klinikum Graz
🇦🇹Graz, Austria
Klinikum Klagenfurt am Wörthersee
🇦🇹Klagenfurt, Austria
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
🇩🇪Lubeck, Germany
Universitätsklinikum Köln AöR
🇩🇪Koln, Germany