Peripheral Artery Disease, Vascular Disease
Conditions
Keywords
Bare Metal Stent, In-Stent Restenosis
Brief summary
The objective of the ISR 14-04 study is to evaluate post-market safety and effectiveness of GORE® VIABAHN® Endoprosthesis for treatment of In-Stent Restenosis of the Superficial Femoral Artery.
Interventions
Sponsors
W.L.Gore & Associates
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
* Patient has a previously implanted (\> 30 days) non-covered stent(s) located in the SFA * Patient has life-style limiting claudication, resting leg pain or minor tissue loss (Rutherford Category 2 - 5) * Patient demonstrates an Ankle Brachial Index (ABI) \<=0.9. If ABI \>0.9 or not measurable, patient is eligible for study if Toe Brachial Index is \<=0.5 * Patient has \>=50% in-stent restenosis and / or an occlusion in a previously implanted (\>30 days) non-covered stent(s) located in the superficial femoral artery defined as beginning at least 1cm below the origin of the profunda femoris artery and ending at least 1cm above the intercondylar notch. * Patient has a maximum total lesion length of 270mm, consisting of in-stent and adjacent occlusive disease * Patient has a reference vessel diameter between 4.0 and 6.5mm * Patient has at least one patent infrapopliteal runoff vessel (\<50% stenosis) not requiring reintervention * Note: Additional Inclusion Criteria may apply
Exclusion criteria
* Patient has a known allergy to stent graft components (nickel-titanium or expanded-polytetrafluoroethylene) * Patient has a known intolerance to anticoagulation or antiplatelet therapy * Patient has known coagulation disorder, including hypercoagulability. * Patient has major distal amputation (above the transmetatarsal) * Patient has any previous surgery in the target vessel * Patient has had previous target vessel in-stent restenosis treated by relining with another stent * Patient has untreated flow-limiting aortoiliac stenotic disease * Note: Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness | 12 Months | Primary Effectiveness is Primary Patency defined as patent blood flow through the study device, which requires either a Peak Systolic Velocity Ratio measurement ≤ 2.5 or patent flow indicated by the Core Lab, and without repeat intervention measured at 12 months and assessed by Kaplan-Meier analysis. |
| Number of Subjects Free From Procedure and Device-Related Serious Adverse Events Within 30 Days of Index Procedure | 30 Days | Primary Safety is defined as freedom from procedure and device-related serious adverse events within 30 days of index procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary Assisted Patency at 30 Days and 12, 24, and 36 Months | 30 days and 12, 24, and 36 months | Primary assisted patency is defined as blood flow through the study device regardless of repeat interventions to maintain patency prior to occlusion. |
| Secondary Patency at 30 Days and 12, 24, and 36 Months | 30 days and 12, 24, and 36 months | Secondary patency is defined as blood flow through the study device regardless of repeat interventions to restore patency after occlusion. |
| Freedom From Target Lesion Revascularization at 30 Days and 12, 24, and 36 Months | 30 days and 12, 24, and 36 months | Target Lesion Revascularization is defined as a repeat intervention within the study device and 5 mm proximal or distal to the edge of the study device to maintain or re-establish patency. |
| Freedom From Major Amputation at 30 Days and 12, 24, and 36 Months | 30 days and 12, 24, and 36 months | Major Amputation is defined as removal of the study limb above the metatarsals, resulting from a vascular event. |
| Change in Ankle Brachial Index at 30 Days | Pre-procedure and 30 Days | The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values \<= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and \>1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure. |
| Change in Ankle Brachial Index at 1 Year | Pre-procedure and 1 Year | The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values \<= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and \>1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure. |
| Number of Subjects With Acute Procedural Success | During hospitalization, approximately 1-2 days | Acute Procedural Success is defined as successful delivery of the study device and complete coverage of the target lesion without a procedure or device-related Serious Adverse Event prior to hospital discharge. |
| Change in Ankle Brachial Index at 3 Years | Pre-procedure and 3 Years | The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values \<= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and \>1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure. |
| Change in Rutherford Category at 30 Days | Pre-procedure and 30 Days | The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome. |
| Change in Rutherford Category at 1 Year | Pre-procedure and 1 Year | The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome. |
| Change in Rutherford Category at 2 Years | Pre-procedure and 2 Years | The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome. |
| Change in Rutherford Category at 3 Years | Pre-procedure and 3 Years | The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome. |
| Stent Fracture at 12, 24, and 36 Months | 12, 24, and 36 months | Device stent fractures that are clearly distinguishable from previously implanted stents will be assessed by the study core lab through x-ray images. |
| Change in Ankle Brachial Index at 2 Years | Pre-procedure and 2 Years | The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values \<= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and \>1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure. |
| Primary Patency at 30 Days and 12, 24, and 36 Months | 30 days and 12, 24, and 36 months | Primary patency is defined as patent blood flow through the study device, which requires either a PSVR measurement ≤ 2.5 or patent flow indicated by the Core Lab, without repeat intervention. |
Countries
Germany, Italy, Sweden, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gore VIABAHN Endoprosthesis Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Gore VIABAHN Endoprosthesis | 108 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 13 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Other | 9 |
| Overall Study | Physician Decision | 6 |
| Overall Study | Surgical Bypass of All Study Devices | 13 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | Gore VIABAHN Endoprosthesis |
|---|---|
| Age, Continuous | 70.7 Years STANDARD_DEVIATION 10.1 |
| Ankle Brachial Index (ABI) | 0.670 Ratio STANDARD_DEVIATION 0.177 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 67 Participants |
| Region of Enrollment Germany | 19 participants |
| Region of Enrollment Italy | 2 participants |
| Region of Enrollment Sweden | 1 participants |
| Region of Enrollment United States | 86 participants |
| Rutherford Category Category 0 | 0 Participants |
| Rutherford Category Category 1 | 0 Participants |
| Rutherford Category Category 2 | 10 Participants |
| Rutherford Category Category 3 | 84 Participants |
| Rutherford Category Category 4 | 3 Participants |
| Rutherford Category Category 5 | 11 Participants |
| Rutherford Category Category 6 | 0 Participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 13 / 108 |
| other Total, other adverse events | 30 / 108 |
| serious Total, serious adverse events | 70 / 108 |
Outcome results
Primary
Number of Subjects Free From Procedure and Device-Related Serious Adverse Events Within 30 Days of Index Procedure
Primary Safety is defined as freedom from procedure and device-related serious adverse events within 30 days of index procedure
Time frame: 30 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gore VIABAHN Endoprosthesis | Number of Subjects Free From Procedure and Device-Related Serious Adverse Events Within 30 Days of Index Procedure | 105 Participants |
Primary
Primary Effectiveness
Primary Effectiveness is Primary Patency defined as patent blood flow through the study device, which requires either a Peak Systolic Velocity Ratio measurement ≤ 2.5 or patent flow indicated by the Core Lab, and without repeat intervention measured at 12 months and assessed by Kaplan-Meier analysis.
Time frame: 12 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gore VIABAHN Endoprosthesis | Primary Effectiveness | 0.715 Probability |
Secondary
Change in Ankle Brachial Index at 1 Year
The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values \<= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and \>1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure.
Time frame: Pre-procedure and 1 Year
Population: Includes all subjects with Ankle Brachial Index values measured at both pre-procedure and 1 year.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gore VIABAHN Endoprosthesis | Change in Ankle Brachial Index at 1 Year | Pre-procedure | 0.693 ratio | Standard Deviation 0.164 |
| Gore VIABAHN Endoprosthesis | Change in Ankle Brachial Index at 1 Year | 1 Year | 0.921 ratio | Standard Deviation 0.188 |
| Gore VIABAHN Endoprosthesis | Change in Ankle Brachial Index at 1 Year | Change at 1 Year | 0.229 ratio | Standard Deviation 0.235 |
Secondary
Change in Ankle Brachial Index at 2 Years
The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values \<= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and \>1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure.
Time frame: Pre-procedure and 2 Years
Population: Includes all subjects with Ankle Brachial Index values measured at both pre-procedure and 2 Years.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gore VIABAHN Endoprosthesis | Change in Ankle Brachial Index at 2 Years | Pre-procedure | 0.700 ratio | Standard Deviation 0.159 |
| Gore VIABAHN Endoprosthesis | Change in Ankle Brachial Index at 2 Years | 2 Years | 0.913 ratio | Standard Deviation 0.187 |
| Gore VIABAHN Endoprosthesis | Change in Ankle Brachial Index at 2 Years | Change at 2 Years | 0.213 ratio | Standard Deviation 0.227 |
Secondary
Change in Ankle Brachial Index at 30 Days
The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values \<= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and \>1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure.
Time frame: Pre-procedure and 30 Days
Population: Includes all subjects with Ankle Brachial Index values measured at both pre-procedure and 30 days.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gore VIABAHN Endoprosthesis | Change in Ankle Brachial Index at 30 Days | Change at 30 Days | 0.325 ratio | Standard Deviation 0.205 |
| Gore VIABAHN Endoprosthesis | Change in Ankle Brachial Index at 30 Days | Pre-procedure | 0.679 ratio | Standard Deviation 0.176 |
| Gore VIABAHN Endoprosthesis | Change in Ankle Brachial Index at 30 Days | 30 Days | 1.004 ratio | Standard Deviation 0.133 |
Secondary
Change in Ankle Brachial Index at 3 Years
The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values \<= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and \>1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure.
Time frame: Pre-procedure and 3 Years
Population: Includes all subjects with Ankle Brachial Index values measured at both pre-procedure and 3 Years.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gore VIABAHN Endoprosthesis | Change in Ankle Brachial Index at 3 Years | Pre-procedure | 0.708 ratio | Standard Deviation 0.162 |
| Gore VIABAHN Endoprosthesis | Change in Ankle Brachial Index at 3 Years | 3 Years | 0.937 ratio | Standard Deviation 0.174 |
| Gore VIABAHN Endoprosthesis | Change in Ankle Brachial Index at 3 Years | Change at 3 Years | 0.229 ratio | Standard Deviation 0.231 |
Secondary
Change in Rutherford Category at 1 Year
The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome.
Time frame: Pre-procedure and 1 Year
Population: Includes all subjects with Rutherford Category measured at both pre-procedure and 1 year.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gore VIABAHN Endoprosthesis | Change in Rutherford Category at 1 Year | Pre-procedure | 3.0 units on a scale | Standard Deviation 0.6 |
| Gore VIABAHN Endoprosthesis | Change in Rutherford Category at 1 Year | 1 Year | 0.8 units on a scale | Standard Deviation 1.1 |
| Gore VIABAHN Endoprosthesis | Change in Rutherford Category at 1 Year | Change at 1 Year | -2.2 units on a scale | Standard Deviation 1.3 |
Secondary
Change in Rutherford Category at 2 Years
The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome.
Time frame: Pre-procedure and 2 Years
Population: Includes all subjects with Rutherford Category measured at both pre-procedure and 2 years.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gore VIABAHN Endoprosthesis | Change in Rutherford Category at 2 Years | Pre-procedure | 3.1 units on a scale | Standard Deviation 0.6 |
| Gore VIABAHN Endoprosthesis | Change in Rutherford Category at 2 Years | 1 Year | 0.6 units on a scale | Standard Deviation 1.1 |
| Gore VIABAHN Endoprosthesis | Change in Rutherford Category at 2 Years | Change at 2 Years | -2.4 units on a scale | Standard Deviation 1.2 |
Secondary
Change in Rutherford Category at 30 Days
The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome.
Time frame: Pre-procedure and 30 Days
Population: Includes all subjects with Rutherford Category measured at both pre-procedure and 30 days.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gore VIABAHN Endoprosthesis | Change in Rutherford Category at 30 Days | Pre-procedure | 3.2 units on a scale | Standard Deviation 0.7 |
| Gore VIABAHN Endoprosthesis | Change in Rutherford Category at 30 Days | 30 Days | 0.6 units on a scale | Standard Deviation 1.2 |
| Gore VIABAHN Endoprosthesis | Change in Rutherford Category at 30 Days | Change at 30 Days | -2.5 units on a scale | Standard Deviation 1.2 |
Secondary
Change in Rutherford Category at 3 Years
The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome.
Time frame: Pre-procedure and 3 Years
Population: Includes all subjects with Rutherford Category measured at both pre-procedure and 3 years.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gore VIABAHN Endoprosthesis | Change in Rutherford Category at 3 Years | Pre-procedure | 3.0 units on a scale | Standard Deviation 0.6 |
| Gore VIABAHN Endoprosthesis | Change in Rutherford Category at 3 Years | 1 Year | 0.8 units on a scale | Standard Deviation 1.2 |
| Gore VIABAHN Endoprosthesis | Change in Rutherford Category at 3 Years | Change at 3 Years | -2.3 units on a scale | Standard Deviation 1.5 |
Secondary
Freedom From Major Amputation at 30 Days and 12, 24, and 36 Months
Major Amputation is defined as removal of the study limb above the metatarsals, resulting from a vascular event.
Time frame: 30 days and 12, 24, and 36 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gore VIABAHN Endoprosthesis | Freedom From Major Amputation at 30 Days and 12, 24, and 36 Months | 30 Day | 1.00 Probability |
| Gore VIABAHN Endoprosthesis | Freedom From Major Amputation at 30 Days and 12, 24, and 36 Months | 12 Month | 1.00 Probability |
| Gore VIABAHN Endoprosthesis | Freedom From Major Amputation at 30 Days and 12, 24, and 36 Months | 24 Month | 1.00 Probability |
| Gore VIABAHN Endoprosthesis | Freedom From Major Amputation at 30 Days and 12, 24, and 36 Months | 36 Month | 1.00 Probability |
Secondary
Freedom From Target Lesion Revascularization at 30 Days and 12, 24, and 36 Months
Target Lesion Revascularization is defined as a repeat intervention within the study device and 5 mm proximal or distal to the edge of the study device to maintain or re-establish patency.
Time frame: 30 days and 12, 24, and 36 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gore VIABAHN Endoprosthesis | Freedom From Target Lesion Revascularization at 30 Days and 12, 24, and 36 Months | 30 Day | 1.00 Probability |
| Gore VIABAHN Endoprosthesis | Freedom From Target Lesion Revascularization at 30 Days and 12, 24, and 36 Months | 12 Month | 0.828 Probability |
| Gore VIABAHN Endoprosthesis | Freedom From Target Lesion Revascularization at 30 Days and 12, 24, and 36 Months | 24 Month | 0.746 Probability |
| Gore VIABAHN Endoprosthesis | Freedom From Target Lesion Revascularization at 30 Days and 12, 24, and 36 Months | 36 Month | 0.668 Probability |
Secondary
Number of Subjects With Acute Procedural Success
Acute Procedural Success is defined as successful delivery of the study device and complete coverage of the target lesion without a procedure or device-related Serious Adverse Event prior to hospital discharge.
Time frame: During hospitalization, approximately 1-2 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gore VIABAHN Endoprosthesis | Number of Subjects With Acute Procedural Success | 107 Participants |
Secondary
Primary Assisted Patency at 30 Days and 12, 24, and 36 Months
Primary assisted patency is defined as blood flow through the study device regardless of repeat interventions to maintain patency prior to occlusion.
Time frame: 30 days and 12, 24, and 36 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gore VIABAHN Endoprosthesis | Primary Assisted Patency at 30 Days and 12, 24, and 36 Months | 30 Day | 1.00 Probability |
| Gore VIABAHN Endoprosthesis | Primary Assisted Patency at 30 Days and 12, 24, and 36 Months | 12 Month | 0.772 Probability |
| Gore VIABAHN Endoprosthesis | Primary Assisted Patency at 30 Days and 12, 24, and 36 Months | 24 Month | 0.643 Probability |
| Gore VIABAHN Endoprosthesis | Primary Assisted Patency at 30 Days and 12, 24, and 36 Months | 36 Month | 0.556 Probability |
Secondary
Primary Patency at 30 Days and 12, 24, and 36 Months
Primary patency is defined as patent blood flow through the study device, which requires either a PSVR measurement ≤ 2.5 or patent flow indicated by the Core Lab, without repeat intervention.
Time frame: 30 days and 12, 24, and 36 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gore VIABAHN Endoprosthesis | Primary Patency at 30 Days and 12, 24, and 36 Months | 30 Day | 0.99 Probability |
| Gore VIABAHN Endoprosthesis | Primary Patency at 30 Days and 12, 24, and 36 Months | 12 Month | 0.715 Probability |
| Gore VIABAHN Endoprosthesis | Primary Patency at 30 Days and 12, 24, and 36 Months | 24 Month | 0.561 Probability |
| Gore VIABAHN Endoprosthesis | Primary Patency at 30 Days and 12, 24, and 36 Months | 36 Month | 0.449 Probability |
Secondary
Secondary Patency at 30 Days and 12, 24, and 36 Months
Secondary patency is defined as blood flow through the study device regardless of repeat interventions to restore patency after occlusion.
Time frame: 30 days and 12, 24, and 36 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gore VIABAHN Endoprosthesis | Secondary Patency at 30 Days and 12, 24, and 36 Months | 30 Day | 1.00 Probability |
| Gore VIABAHN Endoprosthesis | Secondary Patency at 30 Days and 12, 24, and 36 Months | 12 Month | 0.929 Probability |
| Gore VIABAHN Endoprosthesis | Secondary Patency at 30 Days and 12, 24, and 36 Months | 24 Month | 0.822 Probability |
| Gore VIABAHN Endoprosthesis | Secondary Patency at 30 Days and 12, 24, and 36 Months | 36 Month | 0.732 Probability |
Secondary
Stent Fracture at 12, 24, and 36 Months
Device stent fractures that are clearly distinguishable from previously implanted stents will be assessed by the study core lab through x-ray images.
Time frame: 12, 24, and 36 months
Population: Includes all subjects who had x-ray or angiographic data to determine device stent fracture at the reported corresponding follow-up time period..
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gore VIABAHN Endoprosthesis | Stent Fracture at 12, 24, and 36 Months | 12 Month | 0 Participants |
| Gore VIABAHN Endoprosthesis | Stent Fracture at 12, 24, and 36 Months | 24 Month | 0 Participants |
| Gore VIABAHN Endoprosthesis | Stent Fracture at 12, 24, and 36 Months | 36 Month | 0 Participants |