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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WRAPSODY Stent Graft | Experimental | All subjects will receive treatment via WRAPSODY Stent Graft Placement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WRAPSODY Stent Graft Placement | Device | The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Participants With Target Lesion Primary Patency at 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James A Gilbert, MD | Oxford University Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| G. Gennimatas General Hospital of Athens | Athens | 115 27 | Greece | |||
| Queen Elizabeth University Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 30 days |
|
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12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Casey Holland, Senior Director Clinical Operations | Merit Medical Systems, Inc. | +1 (617) 842-0251 | casey.holland@merit.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 7, 2020 | May 20, 2021 | Prot_SAP_000.pdf |
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Single arm treated with investigational device WRAPSODY Stent Graft
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The total number of subjects with Target Lesion Primary Patency at 6 months
| 6 months |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Number of Participants With Anatomic Success | Less than 30% residual stenosis immediately following the study procedure | Immediately following the study procedure |
| Number of Participants With Procedural Success | The achievement of both clinical and anatomic success | 30 days |
| 12 months |
| Glasgow |
| G51 4TF |
| United Kingdom |
| Oxford University Hospitals NHS Foundation Trust | Oxford | OX3 7LE | United Kingdom |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Posted | Count of Participants | Participants | 30 days |
|
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| 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 | Posted | Count of Participants | Participants | 3 months |
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| 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 | Posted | Count of Participants | Participants | 6 months |
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| 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 | Posted | Count of Participants | Participants | 12 months |
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| 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 | Posted | Count of Participants | Participants | 30 days |
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| 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 | Posted | Count of Participants | Participants | 3 months |
|
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| 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 | Posted | Count of Participants | Participants | 6 months |
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| 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 | Posted | Count of Participants | Participants | 12 months |
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| 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 | Posted | Count of Participants | Participants | 30 days |
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| 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 | Posted | Count of Participants | Participants | 3 months |
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| 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 | Posted | Count of Participants | Participants | 6 months |
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| 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 | Posted | Count of Participants | Participants | 12 months |
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| 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 | Posted | Count of Participants | Participants | 30 days |
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| 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 | Posted | Count of Participants | Participants | 3 months |
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| 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 | Posted | Count of Participants | Participants | 6 months |
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| 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 | Posted | Count of Participants | Participants | 12 months |
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| 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 | Posted | Count of Participants | Participants | 30 days |
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| Secondary | Number of Participants With Anatomic Success | Less than 30% residual stenosis immediately following the study procedure | Posted | Count of Participants | Participants | Immediately following the study procedure |
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| Secondary | Number of Participants With Procedural Success | The achievement of both clinical and anatomic success | Posted | Count of Participants | Participants | 30 days |
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| 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. | Posted | Count of Participants | Participants | 12 months |
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| 0 |
| 46 |
| 10 |
| 46 |
| 0 |
| 46 |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Arteriovenous graft thrombosis | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Device dislocation | Product Issues | MedDRA | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
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| Coronavirus test positive | Investigations | MedDRA | Non-systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
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