Venous Occlusion, Venous Stenosis
Conditions
Keywords
Dialysis, Venous Stenosis, Venous Occlusion, Stent Graft
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.
Interventions
DEVICEWRAPSODY Stent Graft Placement
The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Sponsors
Merit Medical Systems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm treated with investigational device WRAPSODY Stent Graft
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 Target Lesion Primary Patency at 3 Months | 3 months | The total number of subjects with Target Lesion Primary Patency at 3 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Stent Graft Integrity (Subset of Subjects With Thoracic Central Venous Target Lesions Only) | 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. |
Countries
Greece, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| WRAPSODY Stent Graft All subjects will receive treatment via WRAPSODY Stent Graft Placement.
WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Access Abandonment | 5 |
| Overall Study | Kidney Transplant | 2 |
Baseline characteristics
| Characteristic | WRAPSODY Stent Graft |
|---|---|
| Age, Continuous | 66.7 years STANDARD_DEVIATION 12.87 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 39 Participants |
| Region of Enrollment Greece | 23 participants |
| Region of Enrollment United Kingdom | 23 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 46 |
| other Total, other adverse events | 0 / 46 |
| serious Total, serious adverse events | 10 / 46 |
Outcome results
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
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WRAPSODY Stent Graft | Number of Participants Without Any Localized or Systemic Safety Events Through 30 Days | 45 Participants |
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
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WRAPSODY Stent Graft | Number of Participants With Target Lesion Primary Patency at 30 Days | 45 Participants |
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
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WRAPSODY Stent Graft | Number of Participants With Access Circuit Primary Patency at 12 Months | 29 Participants |
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
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WRAPSODY Stent Graft | Number of Participants With Access Circuit Primary Patency at 30 Days | 43 Participants |
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
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WRAPSODY Stent Graft | Number of Participants With Access Circuit Primary Patency at 3 Months | 40 Participants |
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
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WRAPSODY Stent Graft | Number of Participants With Access Circuit Primary Patency at 6 Months | 38 Participants |
Secondary
Number of Participants With Anatomic Success
Less than 30% residual stenosis immediately following the study procedure
Time frame: Immediately following the study procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WRAPSODY Stent Graft | Number of Participants With Anatomic Success | 46 Participants |
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
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WRAPSODY Stent Graft | Number of Participants With Assisted Access Circuit Primary Patency at 12 Months | 39 Participants |
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
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WRAPSODY Stent Graft | Number of Participants With Assisted Access Circuit Primary Patency at 30 Days | 45 Participants |
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
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WRAPSODY Stent Graft | Number of Participants With Assisted Access Circuit Primary Patency at 3 Months | 44 Participants |
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
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WRAPSODY Stent Graft | Number of Participants With Assisted Access Circuit Primary Patency at 6 Months | 43 Participants |
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
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WRAPSODY Stent Graft | Number of Participants With Assisted Target Lesion Primary Patency at 12 Months | 39 Participants |
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
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WRAPSODY Stent Graft | Number of Participants With Assisted Target Lesion Primary Patency at 30 Days | 45 Participants |
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
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WRAPSODY Stent Graft | Number of Participants With Assisted Target Lesion Primary Patency at 3 Months | 44 Participants |
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
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WRAPSODY Stent Graft | Number of Participants With Assisted Target Lesion Primary Patency at 6 Months | 43 Participants |
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
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WRAPSODY Stent Graft | Number of Participants With Clinical Success | 45 Participants |
Secondary
Number of Participants With Procedural Success
The achievement of both clinical and anatomic success
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WRAPSODY Stent Graft | Number of Participants With Procedural Success | 45 Participants |
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
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WRAPSODY Stent Graft | Number of Participants With Target Lesion Primary Patency at 12 Months | 33 Participants |
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
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WRAPSODY Stent Graft | Number of Participants With Target Lesion Primary Patency at 3 Months | 44 Participants |
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
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WRAPSODY Stent Graft | Number of Participants With Target Lesion Primary Patency at 6 Months | 42 Participants |
Other Pre-specified
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.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WRAPSODY Stent Graft | Number of Participants With Stent Graft Integrity (Subset of Subjects With Thoracic Central Venous Target Lesions Only) | 8 Participants |