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

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.

Study Overview

• Status: Completed
• Conditions: Venous Stenosis; Venous Occlusion
• Intervention / Treatment: Device: WRAPSODY Stent Graft Placement

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 115 27
    • G. Gennimatas General Hospital of Athens
• United Kingdom
  • Glasgow, United Kingdom, G51 4TF
    • Queen Elizabeth University Hospital
  • Oxford, United Kingdom, OX3 7LE
    • Oxford University Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject has signed informed consent
2. Subject is ≥ 21 years of age
3. 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
4. Angiographic evidence of stenosis
5. The target lesion has ≥ 50% stenosis
6. Subject has clinical or hemodynamic evidence of a venous outflow stenosis or obstruction
7. Full expansion of an appropriately sized standard angioplasty balloon has been achieved during primary angioplasty at the target lesion prior to enrollment

Exclusion Criteria:

1. Subject has undergone an intervention (surgical or percutaneous) of the AVF/AVG <30 days from the date of the initial study procedure
2. 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
3. Active hemodialysis access is not in the arm
4. A pseudoaneurysm is present within the target lesion
5. 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
6. Lesions, other than the target lesion, in the venous outflow circuit with >30% stenosis
7. Known or suspected infection of the hemodialysis access site and/or septicemia
8. Permanent pacemaker or automated implantable cardioverter defibrillator (AICD) on the side with the target lesion
9. Current central venous catheter for dialysis access
10. Uncorrectable coagulation disorders
11. Hypersensitivity to nickel titanium alloy
12. The subject is enrolled in another investigational study
13. The subject is unable or unwilling to comply with the protocol requirements
14. Life expectancy is ≤ 12 months
15. Subject cannot receive heparin or equivalent anticoagulant
16. Allergy to radiographic contrast material which cannot be adequately premedicated
17. Subject is pregnant, breastfeeding, or pre-menopausal and intending to become pregnant
18. Subject's access is anticipated to be abandoned within 3 months
19. Subject has a thoracic central vein obstruction that would lead to stent graft placement across the internal jugular vein
20. Subject's hemodialysis access is thrombosed
21. Active malignancy other than non-melanomatous skin cancer
22. Any other condition deemed exclusionary in the opinion of the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WRAPSODY Stent Graft; All subjects will receive treatment via WRAPSODY Stent Graft Placement.	Device: WRAPSODY Stent Graft Placement; The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein; Other Names: Stent Graft; Covered Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Target Lesion Primary Patency at 3 Months	The total number of subjects with Target Lesion Primary Patency at 3 months	3 months
Number of Participants With Target Lesion Primary Patency at 6 Months	The total number of subjects with Target Lesion Primary Patency at 6 months	6 months
Number of Participants With Target Lesion Primary Patency at 12 Months	The total number of subjects with Target Lesion Primary Patency at 12 months	12 months
Number of Participants With Assisted Target Lesion Primary Patency at 30 Days	The total number of subjects with Assisted Primary Patency of the Target Lesion at 30 days	30 days
Number of Participants With Assisted Target Lesion Primary Patency at 3 Months	The total number of subjects with Assisted Primary Patency of the Target Lesion at 3 months	3 months
Number of Participants With Assisted Target Lesion Primary Patency at 6 Months	The total number of subjects with Assisted Primary Patency of the Target Lesion at 6 months	6 months
Number of Participants With Assisted Target Lesion Primary Patency at 12 Months	The total number of subjects with Assisted Primary Patency of the Target Lesion at 12 months	12 months
Number of Participants With Access Circuit Primary Patency at 30 Days	The total number of subjects with Access Circuit Primary Patency at 30 days	30 days
Number of Participants With Access Circuit Primary Patency at 3 Months	The total number of subjects with Access Circuit Primary Patency at 3 months	3 months
Number of Participants With Access Circuit Primary Patency at 6 Months	The total number of subjects with Access Circuit Primary Patency at 6 months	6 months
Number of Participants With Access Circuit Primary Patency at 12 Months	The total number of subjects with Access Circuit Primary Patency at 12 months	12 months
Number of Participants With Assisted Access Circuit Primary Patency at 30 Days	The total number of subjects with Assisted Access Circuit Primary Patency at 30 days	30 days
Number of Participants With Assisted Access Circuit Primary Patency at 3 Months	The total number of subjects with Assisted Access Circuit Primary Patency at 3 months	3 months
Number of Participants With Assisted Access Circuit Primary Patency at 6 Months	The total number of subjects with Assisted Access Circuit Primary Patency at 6 months	6 months
Number of Participants With Assisted Access Circuit Primary Patency at 12 Months	The total number of subjects with Assisted Access Circuit Primary Patency at 12 months	12 months
Number of Participants With Clinical Success	The resumption of successful dialysis through existing access for at least one session following the initial study procedure	30 days
Number of Participants With Anatomic Success	Less than 30% residual stenosis immediately following the study procedure	Immediately following the study procedure
Number of Participants With Procedural Success	The achievement of both clinical and anatomic success	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Stent Graft Integrity (Subset of Subjects With Thoracic Central Venous Target Lesions Only)	Total number of participants (subset of subjects with thoracic central venous target lesions only) with freedom from stent graft fracture, defined as clear interruption of a stent strut observed in a minimum of two projections taken during the 12 month visit or after determined by DMC/CEC examination of X-Ray images.	12 months

Collaborators and Investigators

• Sponsor: Merit Medical Systems, Inc.
• Investigators: Principal Investigator: James A Gilbert, MD, Oxford University Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2019
• Primary Completion (Actual): February 25, 2020
• Study Completion (Actual): January 20, 2021

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 23, 2018

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Dialysis; Venous Stenosis; Venous Occlusion; Stent Graft
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: CVO-P1-18-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes