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The Merit WRAPSODY™ Endovascular Stent Graft

NCT03644017 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2022-01-21

Study results available
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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.

Conditions

  • Venous Stenosis
  • Venous Occlusion

Interventions

DEVICE

WRAPSODY Stent Graft Placement

The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein

Sponsors & Collaborators

  • Merit Medical Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • James A Gilbert, MD · Oxford University Hospitals NHS Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-29
Primary Completion
2020-02-25
Completion
2021-01-20
FDA Device
Yes

Countries

  • Greece
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03644017 on ClinicalTrials.gov