NCT03644017

The Merit WRAPSODY™ Endovascular Stent Graft

Prospective Investigation of The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Venous Outflow Circuit Obstruction In Hemodialysis Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Merit Medical Systems, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1 study, designed to evaluate the safety and effectiveness of the WRAPSODY Stent Graft for the treatment of venous outflow circuit obstructions in the veins of the arm or thoracic central veins of subjects who receive chronic dialysis treatment for end stage renal disease.

Detailed description

The study will consist of a screening period in which subject eligibility will be determined. Approximately 50 subjects meeting the study entry criteria will be enrolled. Placement of the WRAPSODY stent graft will follow the procedure. Post study procedure subjects will have planned follow-up visits at 30 days, 3, 6 and 12months, and additional visits as referred by the subject's dialysis facility. The primary study safety endpoint will be the proportion of subjects without any localized or systemic safety events through 30 days that affect the access or venous outflow circuit and resulted in surgery, hospitalization, or death. Subjects will continue to be followed up to 12 months for supplementary information.

Conditions

• Venous Stenosis
• Venous Occlusion

Interventions

Type	Name	Description
DEVICE	WRAPSODY Stent Graft Placement	The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein

Timeline

• Start date: 2019-01-29
• Primary completion: 2020-02-25
• Completion: 2021-01-20
• First posted: 2018-08-23
• Last updated: 2022-01-21
• Results posted: 2021-07-21

Locations

3 sites across 2 countries: Greece, United Kingdom

Regulatory

• FDA-regulated device study