The Merit WRAPSODY™ Endovascular Stent Graft

Venous Occlusion Clinical Trial

Official title:

Prospective Investigation of The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Venous Outflow Circuit Obstruction In Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03644017
• Other study ID #: CVO-P1-18-01
• Status: Completed
• Phase: N/A
• Start date: January 29, 2019
• Est. completion date: January 20, 2021

Study information

• Verified date: December 2021
• Source: Merit Medical Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 20, 2021
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Venous Occlusion
• Venous Stenosis

Intervention

Device:
• WRAPSODY Stent Graft Placement
The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein

Locations

Country	Name	City	State
Greece	G. Gennimatas General Hospital of Athens	Athens
United Kingdom	Queen Elizabeth University Hospital	Glasgow
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Merit Medical Systems, Inc.

Countries where clinical trial is conducted

Greece,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Participants With Anatomic Success	Less than 30% residual stenosis immediately following the study procedure	Immediately following the study procedure
Secondary	Number of Participants With Procedural Success	The achievement of both clinical and anatomic success	30 days