Inhibition of Neointimal hyperplasia with Paclitaxel-eluting balloon angioplasty in haemodialysis shunts. A multicenter randomized clinical trial of paclitaxel drug-eluting balloon (DEB) versus standard percutaneous transluminal angioplasty (PTA) to reduce restenosis in patients with haemodialysis access stenoses.
Recruiting
- Conditions
- hemodialysestenosis in dialysis access shunt/fistula10003216
- Registration Number
- NL-OMON45191
- Lead Sponsor
- Cardionovum GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 118
Inclusion Criteria
Subjects with stenosis in native haemodialysis fistulas or prosthetic haemodialysis grafts on the arm, AND
that were previously well functioning, AND
that now present with clinical abnormalities indicating decreased functioning, as defined in the NKF-DOQIcprotocol criteria (National Kidney Foundation 2000)
Exclusion Criteria
Unable to provide informed consent
In-stent restenose (that is: a shunt that has been treated previously with a metallic stent)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary patency through 6 months defined as absence of haemodialysis access<br /><br>malfunctioning according to the NKF-DOQI-protocol criteria (1996) without<br /><br>clinically driven TLR (reintervention of the target lesion due to insufficient<br /><br>dialysis flow).</p><br>
- Secondary Outcome Measures
Name Time Method