Claudication, Peripheral Vascular Diseases
Conditions
Keywords
SFA, Popliteal, Stent, EverFlex
Brief summary
This is a multi-center, non-randomized, single arm study to compare PTA and primary stenting using a single PROTÉGÉ® EverFlex™ stent to performance goals of PTA alone in the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions.
Interventions
DEVICEPROTÉGÉ® EverFlex™ Self-Expanding Stent System
Implantation of a single study device in the native superficial femoral artery or superficial femoral artery and proximal popliteal artery.
Sponsors
Medtronic Endovascular
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
* Stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts) or occluded lesion(s) located in the native superficial femoral artery or superficial femoral and proximal popliteal arteries. * Symptomatic femoral-popliteal atherosclerosis. * Willing to comply with all follow-up evaluations at the specified times. * Provides written informed consent prior to enrollment in the study.
Exclusion criteria
* Previously implanted stent(s) or stent graft(s) in the target vessel. * Planned use of devices other than angioplasty balloons during procedure. * Received endovascular treatment of the target lesion (except stents/stent grafts) within six months of the index procedure. * Life expectancy of less than 12 months. * Symptomatic femoral disease in the opposite limb.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency | 1 Year | Primary stent patency, as determined by the core laboratory, was defined as PSV ratio \< 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure. |
| Major Adverse Events | 30 Days | Major Adverse Events (MAE) was defined as clinically-driven Target Lesion Revascularization (TLR), amputation of treated limb, or all-cause mortality, as adjudicated by the Clinical Events Commettee (CEC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Events | 1 Year | MAE rate at 1 year was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurs within 1 year post-procedure, as adjudicated by the CEC. |
| Stent Fracture Rate | 1, 2 and 3 Years | Stent integrity determined by x-ray at 1, 2 and 3 years post stent implantation. |
| Number of Participants With Decline in Rutherford Clinical Category | 30 days | Defined as an increase of one or more categories in Rutherford Clinical classification compared to baseline. The symptomatic classification is a scale of 0-6, asymptomatic to major tissue loss. |
| Improvement in Rutherford Clinical Category | 1 year | Improvement in Rutherford Clinical Category (RCC) was defined as an improvement in clinical status indicated by a decrease of one or more categories in RCC compared to baseline. |
| Increase in Ankle-Brachial Index From Baseline to 1 Year | 1 Year | Defined as an increase in ancle-brachial index (ABI) at 1 year compared to baseline in subjects with compressible arteries and baseline ABI \< 0.9. |
| Single-Stent Primary Patency | 1 Year | Primary stent patency in subjects with single-stent, as determined by the core laboratory, was defined as PSV ratio \< 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure. Single stents were implanted in 272 subject. |
| Secondary Patency | 1 Year | Secondary patency was defined as PSV ratio \< 2.0 maintained by repeat percutaneous intervention after occlusion of the target lesion. Secondary patency was evaluated by the Kaplan-Meier method in all enrolled subjects. |
| Absolute Claudication Distance Improvement | 1 Year | Absolute claudication distance improvement at 1 year was defined as the increase in walking distance determined by a graded treadmill exercise test. Only assessed in subjects enrolled under study procol versions in which the endpoint was predefined. |
| Walking Improvement | 1 Year | Walking improvement was defined as an increase in Walking Impairment Questionnaire (WIQ) score in subjects who did not have iliac disease treated at the time of the index procedure compared to baseline. |
| Duplex Ultrasound ≤ 2.4 Primary Patency | 1 Year | Defined as a binary duplex ultrasound ratio ≤ 2.4 at the stented target lesion with no clinically-driven reintervention without the stented segment. Duplex Ultrasound ≤ 2.4 primary patency was evaluated by the Kaplan-Meier method in all enrolled subjects. |
| Assisted Primary Patency | 1 Year | Assisted primary patency at 1 year was defined as PSV ratio \< 2.0 as measured by binary duplex ultrasound maintained by repeated percutaneous intervention completed prior to complete vessel closure. Kaplan-Meier assisted primary patency was evaluated in all enrolled subjects. |
| Single-Stent Major Adverse Events | 30 Days | MAE rate in subjects who received a single stent was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurred within 30-days post-procedure, as adjudicated by the CEC. Single stents were implanted in 272 subjects. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EverFlex™ Peripheral Self-Expanding Stent System Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System | 287 |
| Total | 287 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 12 Month Follow-up Visit | Death | 9 |
| 12 Month Follow-up Visit | Lost to Follow-up | 7 |
| 12 Month Follow-up Visit | Missed Visit | 3 |
| 12 Month Follow-up Visit | Withdrawal by Subject | 5 |
| 30 Day Follow-up Visit | Missed Visit | 5 |
| 30 Day Follow-up Visit | Withdrawal by Subject | 2 |
| 6 Month Follow-up Visit | Death | 2 |
| 6 Month Follow-up Visit | Lost to Follow-up | 3 |
| 6 Month Follow-up Visit | Missed Visit | 3 |
| 6 Month Follow-up Visit | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | EverFlex™ Peripheral Self-Expanding Stent System |
|---|---|
| Age, Continuous | 67.7 years STANDARD_DEVIATION 10.7 |
| Region of Enrollment Europe | 43 participants |
| Region of Enrollment United States | 244 participants |
| Sex: Female, Male Female | 97 Participants |
| Sex: Female, Male Male | 190 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 229 / 287 |
| serious Total, serious adverse events | 99 / 287 |
Outcome results
Primary
Major Adverse Events
Major Adverse Events (MAE) was defined as clinically-driven Target Lesion Revascularization (TLR), amputation of treated limb, or all-cause mortality, as adjudicated by the Clinical Events Commettee (CEC)
Time frame: 30 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EverFlex™ Peripheral Self-Expanding Stent System | Major Adverse Events | 0 Percentage of participants with data |
Primary
Primary Patency
Primary stent patency, as determined by the core laboratory, was defined as PSV ratio \< 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure.
Time frame: 1 Year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EverFlex™ Peripheral Self-Expanding Stent System | Primary Patency | 67.7 Percentage of participants with data |
Secondary
Absolute Claudication Distance Improvement
Absolute claudication distance improvement at 1 year was defined as the increase in walking distance determined by a graded treadmill exercise test. Only assessed in subjects enrolled under study procol versions in which the endpoint was predefined.
Time frame: 1 Year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EverFlex™ Peripheral Self-Expanding Stent System | Absolute Claudication Distance Improvement | Baseline | 0.23 Miles | Standard Deviation 0.18 |
| EverFlex™ Peripheral Self-Expanding Stent System | Absolute Claudication Distance Improvement | 1 Year | 0.28 Miles | Standard Deviation 0.34 |
Secondary
Assisted Primary Patency
Assisted primary patency at 1 year was defined as PSV ratio \< 2.0 as measured by binary duplex ultrasound maintained by repeated percutaneous intervention completed prior to complete vessel closure. Kaplan-Meier assisted primary patency was evaluated in all enrolled subjects.
Time frame: 1 Year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EverFlex™ Peripheral Self-Expanding Stent System | Assisted Primary Patency | 86.9 Event free percentage |
Secondary
Duplex Ultrasound ≤ 2.4 Primary Patency
Defined as a binary duplex ultrasound ratio ≤ 2.4 at the stented target lesion with no clinically-driven reintervention without the stented segment. Duplex Ultrasound ≤ 2.4 primary patency was evaluated by the Kaplan-Meier method in all enrolled subjects.
Time frame: 1 Year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EverFlex™ Peripheral Self-Expanding Stent System | Duplex Ultrasound ≤ 2.4 Primary Patency | 77.9 Event free percentage |
Secondary
Improvement in Rutherford Clinical Category
Improvement in Rutherford Clinical Category (RCC) was defined as an improvement in clinical status indicated by a decrease of one or more categories in RCC compared to baseline.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EverFlex™ Peripheral Self-Expanding Stent System | Improvement in Rutherford Clinical Category | 83.6 Percentage of participants with data |
Secondary
Increase in Ankle-Brachial Index From Baseline to 1 Year
Defined as an increase in ancle-brachial index (ABI) at 1 year compared to baseline in subjects with compressible arteries and baseline ABI \< 0.9.
Time frame: 1 Year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EverFlex™ Peripheral Self-Expanding Stent System | Increase in Ankle-Brachial Index From Baseline to 1 Year | Baseline | 0.65 Ratio | Standard Deviation 0.15 |
| EverFlex™ Peripheral Self-Expanding Stent System | Increase in Ankle-Brachial Index From Baseline to 1 Year | 1 Year | 0.89 Ratio | Standard Deviation 0.2 |
Secondary
Major Adverse Events
MAE rate at 1 year was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurs within 1 year post-procedure, as adjudicated by the CEC.
Time frame: 1 Year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EverFlex™ Peripheral Self-Expanding Stent System | Major Adverse Events | Subjects with MAE | 16.8 Percentage of particants with data |
| EverFlex™ Peripheral Self-Expanding Stent System | Major Adverse Events | Death | 2.9 Percentage of particants with data |
| EverFlex™ Peripheral Self-Expanding Stent System | Major Adverse Events | Amputation | 0 Percentage of particants with data |
| EverFlex™ Peripheral Self-Expanding Stent System | Major Adverse Events | Clinically-driven TLR | 13.9 Percentage of particants with data |
Secondary
Number of Participants With Decline in Rutherford Clinical Category
Defined as an increase of one or more categories in Rutherford Clinical classification compared to baseline. The symptomatic classification is a scale of 0-6, asymptomatic to major tissue loss.
Time frame: 30 days
Population: Subjects with available RCC data
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EverFlex™ Peripheral Self-Expanding Stent System | Number of Participants With Decline in Rutherford Clinical Category | 0 Participants |
Secondary
Secondary Patency
Secondary patency was defined as PSV ratio \< 2.0 maintained by repeat percutaneous intervention after occlusion of the target lesion. Secondary patency was evaluated by the Kaplan-Meier method in all enrolled subjects.
Time frame: 1 Year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EverFlex™ Peripheral Self-Expanding Stent System | Secondary Patency | 87.3 Event free percentage |
Secondary
Single-Stent Major Adverse Events
MAE rate in subjects who received a single stent was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurred within 30-days post-procedure, as adjudicated by the CEC. Single stents were implanted in 272 subjects.
Time frame: 30 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EverFlex™ Peripheral Self-Expanding Stent System | Single-Stent Major Adverse Events | 0 Percentage of participants with data |
Secondary
Single-Stent Primary Patency
Primary stent patency in subjects with single-stent, as determined by the core laboratory, was defined as PSV ratio \< 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure. Single stents were implanted in 272 subject.
Time frame: 1 Year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EverFlex™ Peripheral Self-Expanding Stent System | Single-Stent Primary Patency | 68.7 Percentage of participants with data |
Secondary
Stent Fracture Rate
Stent integrity determined by x-ray at 1, 2 and 3 years post stent implantation.
Time frame: 1, 2 and 3 Years
Population: 263 stents analyzable at 1 year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EverFlex™ Peripheral Self-Expanding Stent System | Stent Fracture Rate | 1 year | 0.4 percentage of stents implanted |
| EverFlex™ Peripheral Self-Expanding Stent System | Stent Fracture Rate | 2 year | 1 percentage of stents implanted |
| EverFlex™ Peripheral Self-Expanding Stent System | Stent Fracture Rate | 3 year | 0 percentage of stents implanted |
Secondary
Walking Improvement
Walking improvement was defined as an increase in Walking Impairment Questionnaire (WIQ) score in subjects who did not have iliac disease treated at the time of the index procedure compared to baseline.
Time frame: 1 Year
Population: Subjects with available WIQ data at 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EverFlex™ Peripheral Self-Expanding Stent System | Walking Improvement | 36.8 percent change | Standard Deviation 40.3 |