The Merit WRAPSODY™ Endovascular Stent Graft

Venous Occlusion Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Constriction, Pathologic
• Venous Occlusion
• Venous Stenosis

• NCT number: NCT03644017
• Study type: Interventional
• Source: Merit Medical Systems, Inc.
• Status: Completed
• Phase: N/A
• Start date: January 29, 2019
• Completion date: January 20, 2021