Does the use of paclitaxel coated balloons inhibit restenosis in hemodialysis fistula? Results compared to conventional PTA balloons in a randomised trial.
Phase 4
Completed
- Conditions
- Hemodialysis fistula stenosis Vessel narrowing in fistula of dialysis patiënten10003216
- Registration Number
- NL-OMON36632
- Lead Sponsor
- Albert Schweitzer Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 54
Inclusion Criteria
Hemodialysis patients presenting more than once a year with repetitive severe stenoses of the draining vein of the fistula, evaluated with duplex ultrasound and reconfirmed at angiography. Patients with a life expectancy of at least one year will be included.
Exclusion Criteria
Refusal or no motivation to participate in the study or receive PTA treatment. Pregnancy or planing to become pregnant during the study. Known allergic reactions in the past with regard to iodinated contrast agents, paclitaxel, heparine or aspirine. Under 18 years of age.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints are 12-months patency of the use of placlitaxel coated<br /><br>balloons and conventional balloons. Endpoints being re-intervention, more than<br /><br>50% stenosis of the treated segment of the hemodialysis fistula, occlusion of<br /><br>the fistula at duplex ultrasound and blood flow below 600 ml/min. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are initial angiographic success (less than 30% stenosis),<br /><br>peri-procedural complications (within 24 hrs) and late complications (within 30<br /><br>days). Further secundairy endpoint are time to hemostasis of the puncture site<br /><br>and diameter of hematoma arond the puncture site. Complications include balloon<br /><br>rupture, vessel disruption, significant bleeding, hypotension, allergic<br /><br>reaction, infection, pulmonary embolus, hand ischemia, occlusion and thrombosis<br /><br>of the fistula, immediate surgical intervention and death. Also evaluation with<br /><br>duplex US at 2 weeks, 3, 6, and 24 months will be taken into accopunt as<br /><br>secondary study outcome.</p><br>