The Merit WRAPSODY™ Endovascular Stent Graft

NCT ID: NCT03644017

Last Updated: 2022-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-29
• Study Completion Date: 2021-01-20

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.

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.

Conditions

Venous Stenosis; Venous Occlusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WRAPSODY Stent Graft

All subjects will receive treatment via WRAPSODY Stent Graft Placement.

Group Type: EXPERIMENTAL

WRAPSODY Stent Graft Placement

Intervention Type: DEVICE

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

Interventions

WRAPSODY Stent Graft Placement

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

Intervention Type: DEVICE

Other Intervention Names

Stent Graft; Covered Stent

Eligibility 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merit Medical Systems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James A Gilbert, MD

Role: PRINCIPAL_INVESTIGATOR

Oxford University Hospitals NHS Trust

Locations

G. Gennimatas General Hospital of Athens

Athens, , Greece

Queen Elizabeth University Hospital

Glasgow, , United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, , United Kingdom

Countries

Greece; United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CVO-P1-18-01

Identifier Type: -

Identifier Source: org_study_id