The Merit WRAPSODY™ Endovascular Stent Graft

Not Applicable

Completed

Conditions: Venous Stenosis
Venous Occlusion

Interventions: Device: WRAPSODY Stent Graft Placement

Registration Number: NCT03644017

Lead Sponsor: Merit Medical Systems, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 46

Inclusion Criteria

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

Exclusion Criteria

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
Allergy to radiographic contrast material which cannot be adequately premedicated
Subject is pregnant, breastfeeding, or pre-menopausal and intending to become pregnant
Subject's access is anticipated to be abandoned within 3 months
Subject has a thoracic central vein obstruction that would lead to stent graft placement across the internal jugular vein
Subject's hemodialysis access is thrombosed
Active malignancy other than non-melanomatous skin cancer
Any other condition deemed exclusionary in the opinion of the investigator

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WRAPSODY Stent Graft	WRAPSODY Stent Graft Placement	All subjects will receive treatment via WRAPSODY Stent Graft Placement.

Primary Outcome Measures

Name	Time	Method
Number of Participants Without Any Localized or Systemic Safety Events Through 30 Days	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
Number of Participants With Target Lesion Primary Patency at 30 Days	30 days	The total number of subjects with Target Lesion Primary Patency at 30 days

Secondary Outcome Measures

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

Trial Locations

Locations (3): G. Gennimatas General Hospital of Athens
🇬🇷
Athens, Greece
Oxford University Hospitals NHS Foundation Trust
🇬🇧
Oxford, United Kingdom
Queen Elizabeth University Hospital
🇬🇧
Glasgow, United Kingdom