First Clinical Results of the Merit WRAPSODY™ Cell-Impermeable Endoprosthesis for Treatment of Access Circuit Stenosis in Haemodialysis Patients

• DOI: 10.1007/s00270-021-02953-8
• Publication Date: 2021-09-12T22:02:36Z
• Authors: James Gilbert; Jason Rai; David Kingsmore; John Skousen; Nikolaos Ptohis
• Keywords: Basilic Vein; Clinical endpoint; Cephalic vein; Hemodialysis access

This prospective, observational first in human study evaluated the safety and effectiveness of WRAPSODYTM Cell-impermeable Endoprosthesis (Merit Medical Systems, Inc.) treatment arteriovenous fistula graft access circuit stenosis.Investigators conducted a prospective analysis 46 patients with stenosis from three centres. Treatment sites included peripheral outflow veins (e.g. cephalic arch, basilic vein swing point; 16 10 patients); graft-vein anastomosis (9 central (up to, but not including SVC; 11 patients). Primary outcome measures 30-day freedom circuit-related events target lesion primary patency. Secondary procedural success; device- procedure-related adverse events; patency; secondary In-person follow-up was scheduled at 1, 3, 6, 12 months. An independent data monitoring/clinical event committee adjudicated all reinterventions device/procedure-relatedness for events.All initial procedures were successful. All one patient free through 30 days (97.8% (45/46)). device-related. Over remainder study, as possibly Six- 12-month patency rates 97.7% (42/43) 84.6.% (33/39), respectively. 84.4% (38/45) 65.9% (29/44), respectively.Results suggest that device is safe effective stenoses circuits.Level 2b, cohort study.