Peripheral Vascular Diseases
Conditions
Keywords
Peripheral Arterial Disease, Peripheral Vascular Disease
Brief summary
The objective of the study is collect data on the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface in the treatment of chronic Superficial Femoral Artery disease. Device patency at 12 months is the primary endpoint.
Interventions
DEVICETreatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
Endovascular treatment of the study lesion with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
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
\> * lifestyle limiting claudication, rest pain or minor tissue loss\> * ABI (ankle-brachial index) \< 0.9 or TBI (toe-brachial index) \< 0.5 if ABI is \>0.9 * Stenosis (\>50%) or occlusion of native SFA (superficial femoral artery) \>5cm * Orifice and 1 cm of SFA are patent * Popliteal artery is patent at the intercondylar fossa of the femur to the trifurcation * At least 1 patent run off vessel * Guidewire and deliver system successfully traversed the lesion
Exclusion criteria
\> * Untreated flow-limiting aortoiliac occlusive disease * Any previous stenting or surgery in the target vessel * Femoral or popliteal aneurysm of target vessel * No patent tibial arteries * Prior ipsilateral femoral artery bypass * Major distal amputation (above the transmetatarsal) in either limb * Patients with known sensitivity to Heparin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency at 12 Months | 12 months | Primary patency is defined as no evidence of restenosis (repeat narrowing) or occlusion (total blockage) within the originally treated lesion based on color-coded duplex sonography (color Doppler ultrasound (CDUS). The Peak Systolic Velocity Ratio must be less than 2.5 (PSVR: the result of taking the highest rate of blood flow within the stented region and dividing it by the highest rate of blood flow just above the stented area). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Who Experience Major Device-related Adverse Events Within the First 30 Days | 30 days | If the functioning or characteristics of the device caused or contributed significantly to the adverse event,and if they occurred within 30 days of the procedure, they would be considered major adverse events (MAEs). Major AEs require significant therapy, including an unplanned increase in the level of care, permanent sequelae, hospitalization, or death. |
| Primary Assisted Patency | 12 months | Primary assisted patency is defined as patency in the target lesion maintained by repeat intervention (one or more follow-up procedures) in an attempt to salvage the stent prior to complete occlusion (blockage) of the treated arterial segment, and also includes patients with primary patency. |
| Secondary Patency | 12 months | Secondary patency is defined as patency in the target lesion maintained by repeat intervention (one more more follow-up procedures) after complete occlusion (blockage) of the treated arterial segment, and also includes patients that have primary and primary assisted patency. |
| Device-related Major Adverse Events at 12 Months | 12 months | If the functioning or characteristics of the device caused or contributed significantly to the adverse event (AE), the AE would be related to the device. Major AEs require significant therapy, including an unplanned increase in the level of care, permanent sequelae, hospitalization, or death. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enrolled Subjects The total number of enrolled subjects. | 119 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 5 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Subject returned early (outside window) | 1 |
| Overall Study | Surgical Bypass | 5 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Enrolled Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 61 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants |
| Age Continuous | 66 years STANDARD_DEVIATION 9.6 |
| Region of Enrollment United States | 119 participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 119 |
| serious Total, serious adverse events | 11 / 119 |
Outcome results
Primary
Primary Patency at 12 Months
Primary patency is defined as no evidence of restenosis (repeat narrowing) or occlusion (total blockage) within the originally treated lesion based on color-coded duplex sonography (color Doppler ultrasound (CDUS). The Peak Systolic Velocity Ratio must be less than 2.5 (PSVR: the result of taking the highest rate of blood flow within the stented region and dividing it by the highest rate of blood flow just above the stented area).
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gore Viabahn Endoprosthesis | Primary Patency at 12 Months | 72.9 percentage of subjects |
Secondary
Device-related Major Adverse Events at 12 Months
If the functioning or characteristics of the device caused or contributed significantly to the adverse event (AE), the AE would be related to the device. Major AEs require significant therapy, including an unplanned increase in the level of care, permanent sequelae, hospitalization, or death.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gore Viabahn Endoprosthesis | Device-related Major Adverse Events at 12 Months | 1 event |
Secondary
Primary Assisted Patency
Primary assisted patency is defined as patency in the target lesion maintained by repeat intervention (one or more follow-up procedures) in an attempt to salvage the stent prior to complete occlusion (blockage) of the treated arterial segment, and also includes patients with primary patency.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gore Viabahn Endoprosthesis | Primary Assisted Patency | 85.6 percentage of subjects |
Secondary
Proportion of Subjects Who Experience Major Device-related Adverse Events Within the First 30 Days
If the functioning or characteristics of the device caused or contributed significantly to the adverse event,and if they occurred within 30 days of the procedure, they would be considered major adverse events (MAEs). Major AEs require significant therapy, including an unplanned increase in the level of care, permanent sequelae, hospitalization, or death.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gore Viabahn Endoprosthesis | Proportion of Subjects Who Experience Major Device-related Adverse Events Within the First 30 Days | 0 participants |
Secondary
Secondary Patency
Secondary patency is defined as patency in the target lesion maintained by repeat intervention (one more more follow-up procedures) after complete occlusion (blockage) of the treated arterial segment, and also includes patients that have primary and primary assisted patency.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gore Viabahn Endoprosthesis | Secondary Patency | 92.2 percentage of subjects |