Vascular Stent-Graft Stenosis
Conditions
Brief summary
This study will confirm the efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® stent graft (hereafter referred to as Viabahn) for the treatment of patients with stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft.
Interventions
DEVICEGORE® VIABAHN® Stent Graft
On Day 1, participants will receive the GORE® VIABAHN® Stent Graft.
Sponsors
W.L.Gore & Associates
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participants who developed stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft * Participants who was used to repair vascular access circuits for purposes other than treatment of stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Loss of Primary Patency of Target Lesion | up to 2 years | Primary patency of target lesion is defined as the period during the patency was maintained from initial treatment until occlusion of target lesion or re-treatment of target lesion. |
| Number of Subjects With Loss of Secondary Patency of Target Lesion | up to 2 years | Secondary patency of target lesion is defined as the period during the patency was maintained from initial treatment (including the period of patency after re-treatment). |
| Number of Subjects With Loss of Primary Patency of Vascular Access Circuit | up to 2 years | Primary patency of vascular access circuit is defined as the period during the patency was maintained from initial treatment until occlusion in vascular access or re-treatment in vascular access circuit. |
| Number of Subjects With Loss of Secondary Patency of Vascular Access Circuit | up to 2 years | Secondary patency of vascular access circuit is defined as the period during the patency was maintained from initial treatment until discontinuation of the use of vascular access circuit. |
| Mean Cumulative Number of Re-treatment Per Target Lesion | at 24 months | Mean cumulative number of re-treatment in target lesion is defined as the number of re-treatment performed for target lesion after the initial treatment. |
| Number of Subjects Achieving Technical Success | Day 1 | Technical Success is defined as \< 30% residual stenosis after initial treatment. |
| Number of Subjects Achieving Clinical Success | Day 1 to Month 1 follow up | Clinical Success is defined as the resumption of normal dialysis for at least one session after the initial treatment. |
| Number of Subjects Experiencing Device and Procedure-related Adverse Events | Day 1 to Month 1 follow up | An adverse event (AE) is defined as any unfavorable or unintended sign (including abnormal laboratory changes), symptom, or illness associated with the use of a medical device. Unless worsening of severity or increasing of incidence during the surveillance, the primary disease of the patient is not considered an adverse event. |
| Number of Subjects Experiencing Device Defects | Day 1 to Month 1 follow up | A device defect is defined as a defect such as damage, malfunction, etc. that are widely unfavorable. Regardless of whether they are due to design, marketing, distribution, or use. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GORE® VIABAHN® Stent Graft Participants will be examined 1, 3, 6, 12 and 24 months following the GORE® VIABAHN® Stent Graft installation.
GORE® VIABAHN® Stent Graft: On Day 1, participants will receive the GORE® VIABAHN® Stent Graft. | 124 |
| Total | 124 |
Baseline characteristics
| Characteristic | GORE® VIABAHN® Stent Graft | — |
|---|---|---|
| Age, Continuous | 71.8 years STANDARD_DEVIATION 11.6 | — |
| BMI | 23.58 kg/m^2 STANDARD_DEVIATION 5.39 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Japan | 124 participants | — |
| Sex: Female, Male Female | 71 Participants | — |
| Sex: Female, Male Male | 53 Participants | — |
| Smoking History Currently Smoking | 9 Participants | — |
| Smoking History No history of smoking | 35 Participants | — |
| Smoking History Past Smoking | 10 Participants | — |
| Smoking History Unknown | 70 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 19 / 124 |
| other Total, other adverse events | 74 / 124 |
| serious Total, serious adverse events | 55 / 124 |
Outcome results
Primary
Mean Cumulative Number of Re-treatment Per Target Lesion
Mean cumulative number of re-treatment in target lesion is defined as the number of re-treatment performed for target lesion after the initial treatment.
Time frame: at 24 months
Population: number of target lesions evaluable at 24 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GORE® VIABAHN® Stent Graft | Mean Cumulative Number of Re-treatment Per Target Lesion | 2.052 reinterventions per target lesion |
Primary
Number of Subjects Achieving Clinical Success
Clinical Success is defined as the resumption of normal dialysis for at least one session after the initial treatment.
Time frame: Day 1 to Month 1 follow up
Population: Number of subjects with 1 month follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE® VIABAHN® Stent Graft | Number of Subjects Achieving Clinical Success | 72 Participants |
Primary
Number of Subjects Achieving Technical Success
Technical Success is defined as \< 30% residual stenosis after initial treatment.
Time frame: Day 1
Population: Evaluable subjects. Technical success could not be determined among 14 subjects not assessed for residual stenosis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE® VIABAHN® Stent Graft | Number of Subjects Achieving Technical Success | 110 Participants |
Primary
Number of Subjects Experiencing Device and Procedure-related Adverse Events
An adverse event (AE) is defined as any unfavorable or unintended sign (including abnormal laboratory changes), symptom, or illness associated with the use of a medical device. Unless worsening of severity or increasing of incidence during the surveillance, the primary disease of the patient is not considered an adverse event.
Time frame: Day 1 to Month 1 follow up
Population: subjects on study at 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE® VIABAHN® Stent Graft | Number of Subjects Experiencing Device and Procedure-related Adverse Events | 4 Participants |
Primary
Number of Subjects Experiencing Device Defects
A device defect is defined as a defect such as damage, malfunction, etc. that are widely unfavorable. Regardless of whether they are due to design, marketing, distribution, or use.
Time frame: Day 1 to Month 1 follow up
Population: Subjects on study at 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE® VIABAHN® Stent Graft | Number of Subjects Experiencing Device Defects | 0 Participants |
Primary
Number of Subjects With Loss of Primary Patency of Target Lesion
Primary patency of target lesion is defined as the period during the patency was maintained from initial treatment until occlusion of target lesion or re-treatment of target lesion.
Time frame: up to 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE® VIABAHN® Stent Graft | Number of Subjects With Loss of Primary Patency of Target Lesion | 81 Participants |
Primary
Number of Subjects With Loss of Primary Patency of Vascular Access Circuit
Primary patency of vascular access circuit is defined as the period during the patency was maintained from initial treatment until occlusion in vascular access or re-treatment in vascular access circuit.
Time frame: up to 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE® VIABAHN® Stent Graft | Number of Subjects With Loss of Primary Patency of Vascular Access Circuit | 98 Participants |
Primary
Number of Subjects With Loss of Secondary Patency of Target Lesion
Secondary patency of target lesion is defined as the period during the patency was maintained from initial treatment (including the period of patency after re-treatment).
Time frame: up to 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE® VIABAHN® Stent Graft | Number of Subjects With Loss of Secondary Patency of Target Lesion | 17 Participants |
Primary
Number of Subjects With Loss of Secondary Patency of Vascular Access Circuit
Secondary patency of vascular access circuit is defined as the period during the patency was maintained from initial treatment until discontinuation of the use of vascular access circuit.
Time frame: up to 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE® VIABAHN® Stent Graft | Number of Subjects With Loss of Secondary Patency of Vascular Access Circuit | 18 Participants |