Peripheral Arterial Disease
Conditions
Brief summary
This study will confirm device efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® Endoprosthesis for the treatment of symptomatic peripheral arterial disease in the superficial femoral arteries.
Interventions
Participants receiving the GORE® VIABAHN® Endoprosthesis
Sponsors
W.L.Gore & Associates
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Symptomatic peripheral arterial disease in superficial femoral artery lesions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Assisted Patency | 12 and 24 months | Primary assisted patency is defined as hemodynamic evidence of flow through a device that had not required a Target lesion revascularization to restore flow after total occlusion. Kaplan-Meier estimates created for each time point. |
| Freedom From Target Lesion Revascularization | 1, 12 and 24 months | Revascularization for restenosis or occlusion of the target lesion. Kaplan-Meier estimates created for each time point. |
| Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies | Procedure day, 1, 12, 24, 36, 48 and 60 months | The number and proportion of the subjects for whom the occurrence of serious adverse events were reported. |
| Number of Participants With a Stent Fracture | Month 12, 24, 36, 48 and 60 | The number and proportion of stent fracture as assessed by Core lab |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GORE® VIABAHN® Endoprosthesis Participants with symptomatic peripheral arterial disease in superficial femoral artery lesions.
GORE® VIABAHN® Endoprosthesis: Participants receiving the GORE® VIABAHN® Endoprosthesis | 321 |
| Total | 321 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Amputation that removes study device | 2 |
| Overall Study | Changing hospital | 23 |
| Overall Study | Death | 85 |
| Overall Study | Lost to Follow-up | 42 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Surgical bypass | 3 |
| Overall Study | Unable to attend hospital | 2 |
| Overall Study | Withdrawal by Subject | 27 |
Baseline characteristics
| Characteristic | GORE® VIABAHN® Endoprosthesis | — |
|---|---|---|
| Age, Continuous | 73.9 years STANDARD_DEVIATION 8.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Japan | 321 participants | — |
| Sex: Female, Male Female | 73 Participants | — |
| Sex: Female, Male Male | 248 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 85 / 321 |
| other Total, other adverse events | 0 / 321 |
| serious Total, serious adverse events | 188 / 321 |
Outcome results
Primary
Freedom From Target Lesion Revascularization
Revascularization for restenosis or occlusion of the target lesion. Kaplan-Meier estimates created for each time point.
Time frame: 1, 12 and 24 months
Population: Participant limbs treated
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE® VIABAHN® Endoprosthesis | Freedom From Target Lesion Revascularization | 1 Month | 0.997 probability |
| GORE® VIABAHN® Endoprosthesis | Freedom From Target Lesion Revascularization | 12 Months | 0.924 probability |
| GORE® VIABAHN® Endoprosthesis | Freedom From Target Lesion Revascularization | 24 Months | 0.844 probability |
Primary
Number of Participants With a Stent Fracture
The number and proportion of stent fracture as assessed by Core lab
Time frame: Month 12, 24, 36, 48 and 60
Population: Includes all subjects who had an x-ray to determine device stent fracture status at the reported corresponding follow-up time period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GORE® VIABAHN® Endoprosthesis | Number of Participants With a Stent Fracture | 12 Months | 0 Participants |
| GORE® VIABAHN® Endoprosthesis | Number of Participants With a Stent Fracture | 24 Months | 0 Participants |
| GORE® VIABAHN® Endoprosthesis | Number of Participants With a Stent Fracture | 36 Months | 0 Participants |
| GORE® VIABAHN® Endoprosthesis | Number of Participants With a Stent Fracture | 48 Months | 0 Participants |
| GORE® VIABAHN® Endoprosthesis | Number of Participants With a Stent Fracture | 60 Months | 0 Participants |
Primary
Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies
The number and proportion of the subjects for whom the occurrence of serious adverse events were reported.
Time frame: Procedure day, 1, 12, 24, 36, 48 and 60 months
Population: Participants must have been followed for at least as long as the start day identified for the time period. Participants that discontinued prior to the start day of the time period were not included in the number analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GORE® VIABAHN® Endoprosthesis | Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies | Procedure (Day 0) | 7 Participants |
| GORE® VIABAHN® Endoprosthesis | Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies | 1 Month (Days 0 through 37) | 11 Participants |
| GORE® VIABAHN® Endoprosthesis | Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies | 3 Months (Days 38 through 121) | 3 Participants |
| GORE® VIABAHN® Endoprosthesis | Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies | 6 Months (Days 122 through 212) | 9 Participants |
| GORE® VIABAHN® Endoprosthesis | Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies | 12 Months (Days 213 through 395) | 17 Participants |
| GORE® VIABAHN® Endoprosthesis | Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies | 24 Months (Days 396 through 760) | 20 Participants |
| GORE® VIABAHN® Endoprosthesis | Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies | 36 Months (Days 761 through 1277) | 13 Participants |
| GORE® VIABAHN® Endoprosthesis | Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies | 48 Months (Days 1278 through 1642) | 7 Participants |
| GORE® VIABAHN® Endoprosthesis | Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies | 60 Months (Days 1643 through 1855) | 2 Participants |
Primary
Primary Assisted Patency
Primary assisted patency is defined as hemodynamic evidence of flow through a device that had not required a Target lesion revascularization to restore flow after total occlusion. Kaplan-Meier estimates created for each time point.
Time frame: 12 and 24 months
Population: Participant limbs treated
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE® VIABAHN® Endoprosthesis | Primary Assisted Patency | 24 months | 0.873 probability |
| GORE® VIABAHN® Endoprosthesis | Primary Assisted Patency | 12 months | 0.920 probability |