Categories
Procedure
84.6%
12-Month
Target Lesion
Primary Patency
SAFETY | n/N (%) | SUMMARY OF EVENTS |
---|---|---|
30-Day Freedom from Safety Events | 45/46 (97.8%) | Thrombosis of access circuit – DMC/CEC adjudicated as not device related |
Device-related AEs | 1 | Thrombosed fistula – Adjudicated as possibly device-related, access not salvageable so no imaging to assess relatedness |
TLPP | AVF PERIPHERAL | AVG PERIPHERAL | AVF ANASTOMOSIS | AVF/AVG CENTRAL | TOTAL |
---|---|---|---|---|---|
6 Month | 16/16 (100%) | 9/10 (90%) | 8/8 (100%) | 9/9 (100%) | 42/43 (97.7%) |
12 Month | 11/14 (78.6%) | 6/7 (85.7%) | 7/9 (77.8%) | 9/9 (100%) | 33/39 (84.6%) |
ACPP | AVF PERIPHERAL | AVG PERIPHERAL | AVG ANASTOMOSIS | AVF/AVG CENTRAL | TOTAL |
---|---|---|---|---|---|
6 Month | 13/16 (81.3%) | 9/10 (90%) | 8/8 (100%) | 8/11 (72.7%) | 38/45 (84.4%) |
12 Month | 10/15 (66.7%) | 7/10 (70%) | 5/8 (62.5%) | 7/11 (63.6%) | 29/44 (65.9%) |
Principal Investigator
Consultant Transplant & Access Surgeon
Oxford University Hospitals (United Kingdom)
DESIGN | PURPOSE | SUBJECT POPULATION | PRIMARY STUDY OBJECTIVES | FOLLOW-UP |
---|---|---|---|---|
• Prospective • 3 Centre • Single arm |
Safety & effectiveness of WRAPSODY in treatment of stenosis or occlusion within dialysis access circuit | 46 Haemodiaylsis patients • AV fistula (AVF) • AV graft (AVG) Clinical relevant stenosis or obstruction (≥ 50%) without additional thrombus or 2° lesions |
Safety: Proportion without any localised or systemic safety events through 30 days affecting the access or venous outflow circuit and resulted in surgery, hospitalisation, or death
Effectiveness: Proportion with TLPP at 30 days |
30 Days, 3 Months, 6 Months & 12 Months
Independent DMC/CEC adjudicated |
Publication References