ESRD, Kidney Diseases
Conditions
Keywords
Hemodialysis Access
Brief summary
This is a multi-center clinical study in subjects requiring arteriovenous grafts in the upper extremity for hemodialysis access. All subjects will provide informed consent before undergoing any study procedures. The study will consist of multiple subject visits and telephone contacts during the 52 week study period. During the study period subjects must also maintain an appropriate hemodialysis schedule. IDE Number: G060250
Interventions
DEVICEVascular Wrap Paclitaxel-Eluting Mesh
0.9 µg/mm\^2 paclitaxel
DEVICELifespan® ePTFE Vascular Graft
vascular graft
Sponsors
Angiotech Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. be ≥ 18 years of age; 2. if female of childbearing potential, provide evidence of a negative pregnancy test within 3 days prior to graft placement (Day -3 to Day 0); 3. be a candidate for a new end-to-side arteriovenous anastomosis graft placed in the upper extremity; 4. have an outflow vein of greater than or equal to 3 mm in diameter; 5. be able to effectively communicate with study personnel; 6. be considered by the physician to be available for subsequent visits; 7. be willing to comply with all aspects of the treatment and evaluation schedule over a 52 week duration; 8. allow representatives of the sponsor, designated CRO, Institutional Review Board (IRB), the Ethics Committee, and U.S. Food and Drug Administration (FDA) to review his/her relevant medical records; 9. sign and date an IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures; 10. must agree to participate in protocol 014-VWAV07, a safety study to run consecutively for an additional 4 years or until Post-Market Approval (PMA), whichever is longer; and 11. have the Lifespan® ePTFE Vascular Graft successfully implanted.
Exclusion criteria
1. pregnant, breast-feeding, or female of childbearing potential who do not agree to remain abstinent or to use a contraceptive method during the study period. Non-childbearing potential is defined as either post-menopausal (amenorrheic for at least 1 year) or surgically sterile. Surgically sterile is defined as tubal ligation or the absence of the uterus and/or ovaries; 2. male of childbearing potential, who does not agree to remain abstinent or to use contraception to prevent fathering a child during the course of the study. Non-childbearing potential is defined as vasectomy or bilateral orchiectomy; 3. a central venous stenosis on the ipsilateral side is documented; 4. a hypercoagulable state is documented; 5. life expectancy is less than one year; 6. an organ transplant is expected within 6 months of test or control product (study products) placement; 7. hypersensitivity to any component of the study products or procedural materials or medications is known; 8. concurrently involved in another investigational study; 9. a study product being investigated by others has been received within 30 days prior to randomization in this trial; 10. the study product being studied in this trial has previously been received; 11. uncontrolled hypertension with systolic BP \>200mmHg or diastolic BP \>115mmHg is present at screening; 12. currently receiving chemotherapy or radiation therapy; or 13. placement of a new end-to-end arteriovenous anastomosis graft is required.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-loss of Target Site Primary Patency | 1 year | Subjects had primary patency at the target site from graft placement until an intervention on the target site occurred. The duration between graft implantation and graft abandonment due to loss of patency at the target site was the time-to-loss of primary patency. Note: The study was halted early and therefore became underpowered to analyze efficacy as detailed in the protocol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 1 year | adverse events with at least 5% incidence, reported as number of subjects experiencing the event (rather than total number of events). Adverse events were collected via subject querying at each visit and telephone contact, and by medical record review. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vascular Wrap and Graft Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh | 112 |
| Lifespan® ePTFE Vascular Graft Lifespan® ePTFE Vascular Graft Only | 110 |
| Total | 222 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 21 | 17 |
| Overall Study | Lost to Follow-up | 6 | 8 |
| Overall Study | not listed | 0 | 2 |
| Overall Study | Withdrawal by Subject | 8 | 4 |
Baseline characteristics
| Characteristic | Lifespan® ePTFE Vascular Graft | Vascular Wrap and Graft | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 48 Participants | 58 Participants | 106 Participants |
| Age, Categorical Between 18 and 65 years | 62 Participants | 54 Participants | 116 Participants |
| Age Continuous | 61 years STANDARD_DEVIATION 15.58 | 64 years STANDARD_DEVIATION 13.72 | 63 years STANDARD_DEVIATION 14.7 |
| Region of Enrollment United States | 110 participants | 112 participants | 222 participants |
| Sex: Female, Male Female | 65 Participants | 61 Participants | 126 Participants |
| Sex: Female, Male Male | 45 Participants | 51 Participants | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 106 / 110 | 110 / 112 |
| serious Total, serious adverse events | 17 / 110 | 21 / 112 |
Outcome results
Primary
Time-to-loss of Target Site Primary Patency
Subjects had primary patency at the target site from graft placement until an intervention on the target site occurred. The duration between graft implantation and graft abandonment due to loss of patency at the target site was the time-to-loss of primary patency. Note: The study was halted early and therefore became underpowered to analyze efficacy as detailed in the protocol.
Time frame: 1 year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vascular Wrap and Graft | Time-to-loss of Target Site Primary Patency | 130 days |
| Lifespan® ePTFE Vascular Graft | Time-to-loss of Target Site Primary Patency | 159 days |
Secondary
Adverse Events
adverse events with at least 5% incidence, reported as number of subjects experiencing the event (rather than total number of events). Adverse events were collected via subject querying at each visit and telephone contact, and by medical record review.
Time frame: 1 year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vascular Wrap and Graft | Adverse Events | Total Number of Adverse Events | 1451 participants |
| Vascular Wrap and Graft | Adverse Events | Serious Adverse Events (deaths only) | 17 participants |
| Lifespan® ePTFE Vascular Graft | Adverse Events | Total Number of Adverse Events | 1164 participants |
| Lifespan® ePTFE Vascular Graft | Adverse Events | Serious Adverse Events (deaths only) | 21 participants |