The Merit WRAPSODY™ Endovascular Stent Graft

• ClinicalTrials.gov Identifier: NCT03644017
• Recruitment Status: Completed
• First Posted: August 23, 2018
• Results First Posted: July 21, 2021
• Last Update Posted: January 21, 2022
• Sponsor: Merit Medical Systems, Inc.
• Information provided by (Responsible Party): Merit Medical Systems, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Venous Stenosis; Venous Occlusion	Device: WRAPSODY Stent Graft Placement	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 46 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single arm treated with investigational device WRAPSODY Stent Graft
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Investigation of The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Venous Outflow Circuit Obstruction In Hemodialysis Patients
• Actual Study Start Date: January 29, 2019
• Actual Primary Completion Date: February 25, 2020
• Actual Study Completion Date: January 20, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Number of Participants Without Any Localized or Systemic Safety Events Through 30 Days [ Time Frame: 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
2. Number of Participants With Target Lesion Primary Patency at 30 Days [ Time Frame: 30 days ]
   The total number of subjects with Target Lesion Primary Patency at 30 days

Secondary Outcome Measures :

1. Number of Participants With Target Lesion Primary Patency at 3 Months [ Time Frame: 3 months ]
   The total number of subjects with Target Lesion Primary Patency at 3 months
2. Number of Participants With Target Lesion Primary Patency at 6 Months [ Time Frame: 6 months ]
   The total number of subjects with Target Lesion Primary Patency at 6 months
3. Number of Participants With Target Lesion Primary Patency at 12 Months [ Time Frame: 12 months ]
   The total number of subjects with Target Lesion Primary Patency at 12 months
4. Number of Participants With Assisted Target Lesion Primary Patency at 30 Days [ Time Frame: 30 days ]
   The total number of subjects with Assisted Primary Patency of the Target Lesion at 30 days
5. Number of Participants With Assisted Target Lesion Primary Patency at 3 Months [ Time Frame: 3 months ]
   The total number of subjects with Assisted Primary Patency of the Target Lesion at 3 months
6. Number of Participants With Assisted Target Lesion Primary Patency at 6 Months [ Time Frame: 6 months ]
   The total number of subjects with Assisted Primary Patency of the Target Lesion at 6 months
7. Number of Participants With Assisted Target Lesion Primary Patency at 12 Months [ Time Frame: 12 months ]
   The total number of subjects with Assisted Primary Patency of the Target Lesion at 12 months
8. Number of Participants With Access Circuit Primary Patency at 30 Days [ Time Frame: 30 days ]
   The total number of subjects with Access Circuit Primary Patency at 30 days
9. Number of Participants With Access Circuit Primary Patency at 3 Months [ Time Frame: 3 months ]
   The total number of subjects with Access Circuit Primary Patency at 3 months
10. Number of Participants With Access Circuit Primary Patency at 6 Months [ Time Frame: 6 months ]
    The total number of subjects with Access Circuit Primary Patency at 6 months
11. Number of Participants With Access Circuit Primary Patency at 12 Months [ Time Frame: 12 months ]
    The total number of subjects with Access Circuit Primary Patency at 12 months
12. Number of Participants With Assisted Access Circuit Primary Patency at 30 Days [ Time Frame: 30 days ]
    The total number of subjects with Assisted Access Circuit Primary Patency at 30 days
13. Number of Participants With Assisted Access Circuit Primary Patency at 3 Months [ Time Frame: 3 months ]
    The total number of subjects with Assisted Access Circuit Primary Patency at 3 months
14. Number of Participants With Assisted Access Circuit Primary Patency at 6 Months [ Time Frame: 6 months ]
    The total number of subjects with Assisted Access Circuit Primary Patency at 6 months
15. Number of Participants With Assisted Access Circuit Primary Patency at 12 Months [ Time Frame: 12 months ]
    The total number of subjects with Assisted Access Circuit Primary Patency at 12 months
16. Number of Participants With Clinical Success [ Time Frame: 30 days ]
    The resumption of successful dialysis through existing access for at least one session following the initial study procedure
17. Number of Participants With Anatomic Success [ Time Frame: Immediately following the study procedure ]
    Less than 30% residual stenosis immediately following the study procedure
18. Number of Participants With Procedural Success [ Time Frame: 30 days ]
    The achievement of both clinical and anatomic success

Other Outcome Measures:

1. Number of Participants With Stent Graft Integrity (Subset of Subjects With Thoracic Central Venous Target Lesions Only) [ Time Frame: 12 months ]
   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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Greece

G. Gennimatas General Hospital of Athens

Athens, Greece, 115 27

United Kingdom

Queen Elizabeth University Hospital

Glasgow, United Kingdom, G51 4TF

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom, OX3 7LE

Sponsors and Collaborators

Merit Medical Systems, Inc.

Investigators

• Principal Investigator: James A Gilbert, MD; Oxford University Hospitals NHS Trust

  Study Documents (Full-Text)

Documents provided by Merit Medical Systems, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] October 7, 2020

More Information

• Responsible Party: Merit Medical Systems, Inc.
• ClinicalTrials.gov Identifier: NCT03644017
• Other Study ID Numbers: CVO-P1-18-01
• First Posted: August 23, 2018
• Results First Posted: July 21, 2021
• Last Update Posted: January 21, 2022
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Merit Medical Systems, Inc.:

Dialysis; Venous Stenosis; Venous Occlusion; Stent Graft

Additional relevant MeSH terms:

Constriction, Pathologic; Pathological Conditions, Anatomical