Constriction, Pathologic
Conditions
Brief summary
The objective of this clinical study is to evaluate the performance of the Optimized FLAIR™ Delivery System.
Interventions
DEVICEFLAIR™ Endovascular Stent Graft
The FLAIR™ Endovascular Stent Graft is designed to treat venous anastomotic stenoses of AV access grafts, providing both structural support of the site following angioplasty (stent), and a barrier to locally recurrent flow-limiting neointimal tissue growth (covering/graft).
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject is either a male or non-pregnant female ≥ 18 years old. * The subject has been properly informed about the study per IRB requirements, and has signed and dated the IRB-approved ICF. * The subject is willing to comply with the protocol requirements and can be contacted by telephone. * The subject has a synthetic AV access graft located in an arm that has been implanted for \> 30 days and has undergone at least one successful dialysis session prior to the index procedure. * Angiographic evidence indicates that the subject has a stenosis of \>50% located at the graft-vein anastomosis of the subject's synthetic AV access graft. * The target lesion is estimated to be ≤ 7 cm in length by angiography prior to performance of any interventional procedures. * The entire target lesion is located within 7 cm of the graft-vein anastomosis, as verified by angiography, such that approximately 1 cm of the FLAIR™ Endovascular Stent Graft will extend into non-diseased vein and approximately 1 cm but no more than 2 cm of the FLAIR™ Endovascular Stent Graft will extend into non-diseased AV graft. * Graft diameter at the deployment site is between 5 mm and 8 mm, as verified by angiography. * Full expansion of an appropriately sized angioplasty balloon, in the operator's judgment, can be achieved during primary angioplasty.
Exclusion criteria
* The subject has a life expectancy of \< 6 months. * The presence of a previously placed stent and/or stent graft located in the treatment area. The treatment area is defined as the entire target lesion and 1 cm of landing zone into both non-diseased AV graft and non-diseased vein. * The subject has an infected AV access graft or other infection. * The location of the target lesion would require that the FLAIR™ Endovascular Stent Graft be deployed fully across the elbow joint. * The location of the target lesion would require that the FLAIR™ Endovascular Stent Graft cross an angle (between the outflow vein and synthetic AV access graft) that is \> 90 degrees. * The subject has an uncorrected blood coagulation disorder. * The subject has a known allergy or sensitivity to contrast media which cannot be adequately pre-medicated. * Subject is currently enrolled or scheduled to be enrolled in other investigations that conflict with follow-up testing or confounds data in this trial. * The subject has a known hypersensitivity to nickel-titanium.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success for Delivery | Measured at the time of implantation (Day 0) | defined as deployment of the implant to the intended location, assessed at the time of the index procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Device/Procedure-related Adverse Events(Safety of Delivery) | Index Procedure to 30 days | Device/Procedure-related adverse events from the index procedure through 30 days post procedure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FLAIR Endovascular Stent Graft Patients treated with the FLAIR Endovascular Stent Graft | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | FLAIR Endovascular Stent Graft |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 64.8 years STANDARD_DEVIATION 15.14 |
| Gender Female | 17 Participants |
| Gender Male | 13 Participants |
| Region of Enrollment United States | 30 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Technical Success for Delivery
defined as deployment of the implant to the intended location, assessed at the time of the index procedure.
Time frame: Measured at the time of implantation (Day 0)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FLAIR Endovascular Stent Graft | Technical Success for Delivery | 100 Percentage of successful implantations |
Secondary
Number of Device/Procedure-related Adverse Events(Safety of Delivery)
Device/Procedure-related adverse events from the index procedure through 30 days post procedure
Time frame: Index Procedure to 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FLAIR Endovascular Stent Graft | Number of Device/Procedure-related Adverse Events(Safety of Delivery) | 1 Number of Device/Procedure events |