The Merit WRAPSODY™ Endovascular Stent Graft

NCT03644017 | Completed Results DMC FDA Device

• 1 other identifier: CVO-P1-18-01
• Study Type: interventional
• Target: 46
• Locations: 2 countries
• Sites: 3

Brief 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

Keywords

Dialysis; Venous Stenosis; Venous Occlusion; Stent Graft

Outcome Measures

Primary Outcomes (2)

• Number of Participants Without Any Localized or Systemic Safety Events Through 30 Days

  The total number 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

  30 days

• Number of Participants With Target Lesion Primary Patency at 30 Days

  The total number of subjects with Target Lesion Primary Patency at 30 days

  30 days

Secondary Outcomes (18)

• Number of Participants With Target Lesion Primary Patency at 3 Months

  3 months

• Number of Participants With Target Lesion Primary Patency at 6 Months

  6 months

• Number of Participants With Target Lesion Primary Patency at 12 Months

  12 months

• Number of Participants With Assisted Target Lesion Primary Patency at 30 Days

  30 days

• Number of Participants With Assisted Target Lesion Primary Patency at 3 Months

  3 months

Other Outcomes (1)

• Number of Participants With Stent Graft Integrity (Subset of Subjects With Thoracic Central Venous Target Lesions Only)

  12 months

Study Arms (1)

WRAPSODY Stent Graft

EXPERIMENTAL

All subjects will receive treatment via WRAPSODY Stent Graft Placement.

Device: WRAPSODY Stent Graft Placement

Interventions

WRAPSODY Stent Graft Placement DEVICE

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

Also known as: Stent Graft, Covered Stent

WRAPSODY Stent Graft

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has signed informed consent
• Subject is ≥ 21 years of age
• Subject is undergoing chronic hemodialysis or other forms of renal replacement therapy including transplantation and has one of the following being used: a. AV graft placed in the arm ≥30 days prior OR b. Mature fistula in the arm with at least one successful dialysis session completed
• Angiographic evidence of stenosis
• The target lesion has ≥ 50% stenosis
• Subject has clinical or hemodynamic evidence of a venous outflow stenosis or obstruction
• Full expansion of an appropriately sized standard angioplasty balloon has been achieved during primary angioplasty at the target lesion prior to enrollment

You may not qualify if:

• Subject has undergone an intervention (surgical or percutaneous) of the AVF/AVG \<30 days from the date of the initial study procedure
• Subject has had a previous stent or stent graft placed in the venous outflow circuit ≤30 days from the date of the initial study procedure
• Active hemodialysis access is not in the arm
• A pseudoaneurysm is present within the target lesion
• Target lesion is in SVC, IJV, under the clavicle, across the elbow, in the needling segment of AVF or AVG anastomosis, located within a stent
• Lesions, other than the target lesion, in the venous outflow circuit with \>30% stenosis
• Known or suspected infection of the hemodialysis access site and/or septicemia
• Permanent pacemaker or automated implantable cardioverter defibrillator (AICD) on the side with the target lesion
• Current central venous catheter for dialysis access
• Uncorrectable coagulation disorders
• Hypersensitivity to nickel titanium alloy
• The subject is enrolled in another investigational study
• The subject is unable or unwilling to comply with the protocol requirements
• Life expectancy is ≤ 12 months
• Subject cannot receive heparin or equivalent anticoagulant

Sponsors & Collaborators

• Merit Medical Systems, Inc.: lead

Study Sites (3)

G. Gennimatas General Hospital of Athens

Athens, 115 27, Greece

Location

Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 7LE, United Kingdom

Location

Results Point of Contact

• Title: Casey Holland, Senior Director Clinical Operations
• Organization: Merit Medical Systems, Inc.

casey.holland@merit.com

+1 (617) 842-0251

Study Officials

• James A Gilbert, MD

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm treated with investigational device WRAPSODY Stent Graft

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 23, 2018
• Study Start: January 29, 2019
• Primary Completion: February 25, 2020
• Study Completion: January 20, 2021
• Last Updated: January 21, 2022
• Results First Posted: July 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); GR (1)