At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective, Randomized, Controlled, Multicenter Study Comparing the Merit WRAPSODY™ Endovascular Stent Graft to Percutaneous Transluminal Angioplasty for Treatment of Venous Outflow Circuit Stenosis or Occlusion in Hemodialysis Patients. The WAVE Study
In Brief
A clinical study evaluating Merit WRAPSODY Endovascular Stent Graft and PTA for Venous Stenosis and Venous Occlusion. Completed, enrolled 357 participants across 43 sites in 4 countries.
Signals
Detailed Summary
The purpose of the study is to demonstrate the safety and efficacy of the Merit WRAPSODY Endovascular Stent Graft for treatment of stenosis or occlusion within the dialysis access outflow circuit
Study Details
Timeline
Arms & Interventions
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Interventions
Target lesion treated with stent graft placement
Target lesion treated with standard percutaneous transluminal angioplasty (PTA)