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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTA and Stenting with EverFlex device | Experimental | Qualified subjects undergo treatment of atherosclerotic lesions in the native SFA/SFA/PPA with PTA and stenting using the PROTÉGÉ® EverFlex™ Self-Expanding Stent System |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROTÉGÉ® EverFlex™ Self-Expanding Stent System | Device | Implantation of a single study device in the native superficial femoral artery or superficial femoral artery and proximal popliteal artery. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 Year |
| 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) | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon Matsumura, MD | University of Wisconsin, Madison | Principal Investigator |
| Krishna Rocha-Singh, MD | Prairie Heart Institute | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23642924 | Result | Matsumura JS, Yamanouchi D, Goldstein JA, Pollock CW, Bosiers M, Schultz GA, Scheinert D, Rocha-Singh KJ. The United States StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent SYstem II (DURABILITY II). J Vasc Surg. 2013 Jul;58(1):73-83.e1. doi: 10.1016/j.jvs.2012.12.066. Epub 2013 May 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | EverFlexâ„¢ Peripheral Self-Expanding Stent System | Subjects recieved the EverFlexâ„¢ Peripheral Self-Expanding Stent System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment |
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| 30 Day Follow-up Visit |
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| 6 Month Follow-up Visit |
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| 12 Month Follow-up Visit |
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| ID | Title | Description |
|---|---|---|
| BG000 | EverFlexâ„¢ Peripheral Self-Expanding Stent System | Subjects recieved the EverFlexâ„¢ Peripheral Self-Expanding Stent System |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | Percentage of participants with data | 1 Year |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EverFlexâ„¢ Peripheral Self-Expanding Stent System | Subjects recieved the EverFlex Peripheral Self-Expanding Stent |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Access site complication - Hematoma | General disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Cihlar | Medtronic | 763-398-7932 | stephanie.a.cihlar@medtronic.com |
| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D058729 | Peripheral Arterial Disease |
| D012816 | Signs and Symptoms |
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| 1 Year |
| 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. | 30 Days |
| 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. | 1 Year |
| Stent Fracture Rate | Stent integrity determined by x-ray at 1, 2 and 3 years post stent implantation. | 1, 2 and 3 Years |
| 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. | 30 days |
| 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. | 1 year |
| 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. | 1 Year |
| 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. | 1 Year |
| 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. | 1 Year |
| 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. | 1 Year |
| 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. | 1 Year |
| 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. | 1 Year |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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) | Posted | Number | Percentage of participants with data | 30 Days |
|
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| 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. | Posted | Number | Percentage of participants with data | 1 Year |
|
|
|
| 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. | Posted | Number | Percentage of participants with data | 30 Days |
|
|
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| 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. | Posted | Number | Percentage of particants with data | 1 Year |
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| Secondary | Stent Fracture Rate | Stent integrity determined by x-ray at 1, 2 and 3 years post stent implantation. | 263 stents analyzable at 1 year | Posted | Number | percentage of stents implanted | 1, 2 and 3 Years | Stent Implanted | Stent Implanted |
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| 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. | Subjects with available RCC data | Posted | Count of Participants | Participants | 30 days |
|
|
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| 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. | Posted | Number | Percentage of participants with data | 1 year |
|
|
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| 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. | Posted | Mean | Standard Deviation | Ratio | 1 Year |
|
|
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| 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. | Posted | Number | 95% Confidence Interval | Event free percentage | 1 Year |
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| 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. | Posted | Number | 95% Confidence Interval | Event free percentage | 1 Year |
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| 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. | Posted | Mean | Standard Deviation | Miles | 1 Year |
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| 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. | Subjects with available WIQ data at 1 year | Posted | Mean | Standard Deviation | percent change | 1 Year |
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| 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. | Posted | Number | 95% Confidence Interval | Event free percentage | 1 Year |
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| 99 |
| 287 |
| 229 |
| 287 |
| Access site complication - Pseudoaneurysm | General disorders |
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| Acute Stent Thrombosis | General disorders |
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| Allergic reaction to contrast dye | General disorders |
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| Allergic reaction to procedure meds | General disorders |
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| Amputation of treated limb above metatarsal line | General disorders |
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| Amputation of treated limb below metatarsal line | General disorders |
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| Artery perforation | General disorders |
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| Death | General disorders |
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| Dissection | General disorders |
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| GI bleeding | General disorders |
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| Hypotension | General disorders |
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| Other Respiratory Issues | General disorders |
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| Other Vascular Disorders | General disorders |
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| Percutaneous revascularization of target vessel | General disorders |
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| Renal Failure | General disorders |
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| Restenosis | General disorders |
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| Stent misplacement | General disorders |
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| Stent/Vessel thrombosis | General disorders |
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| Stroke | General disorders |
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| Other | General disorders |
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| Other Bleeding/lymphatic system disorders | General disorders |
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| Other Cardiac Disorders | Cardiac disorders |
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| Other Gastrointestinal Disorders | Gastrointestinal disorders |
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| Other Infections | Infections and infestations |
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| Other Musculoskeletal disorders | Musculoskeletal and connective tissue disorders |
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| Other Vascular Disorders | Vascular disorders |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| Clinically-driven TLR |
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| 2 year |
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| 3 year |
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