12-Month Published Safety & Performance Results
Results
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 |
Target Lesion Primary Patency
| 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%) |
Access Circuit Primary Patency
| 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%) |
Study Details
MR. JAMES GILBERT
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 |
CONCLUSIONS1
- “Study device can safely and effectively treat stenoses in the peripheral outflow and central veins of AV access circuits.”
- “6- and 12-month TLPP and ACPP rates were unexpectedly high.”
- “While needing further confirmation, the study device’s design may be a contributing factor in limiting restenosis.”
- “This degree of patency preservation should reduce revision frequency and access abandonment rates, leading to less hospitalisation and lower healthcare costs.”
- “Additional follow-up in larger RCTs is needed to verify these results.”
Publication References
- Gilbert J, et al.; CardioVascular and Interventional Radiology (2021). https://doi.org/10.1007/s00270-021-02953-8
- Falk A, Maya ID, Yevzlin AS; RESCUE investigators. A prospective, randomized study of an expanded polytetrafluoroethylene stent graft versus balloon angioplasty for in-stent restenosis in arteriovenous grafts and fistulae: two-year results of the RESCUE study. J Vasc Interv Radiol. 2016;27:1465-1476
- Vesely T, DaVanzo W, Behrend T, et al. Balloon angioplasty versus Viabahn stent graft for treatment of failing or thrombosed prosthetic hemodialysis grafts. J Vasc Surg. 2016;64:1400-1410.e1.
- W. L. Gore & Associates Inc. Viabahn Endoprosthesis Instructions For Use. January 2021 Reference 20023402
- Bard Peripheral Vascular. Covera vascular covered stent instructions for use. Rev.4 / 08-18. http://www.bardpv.com/eifu/uploads/BAWB05872R4-Covera-Vascular-Covered-Stent-IFU.pdf. Accessed October 10, 2021.