Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE)

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the intermediate and long-term effectiveness of stand-alone atherectomy treatment of peripheral arterial disease in the legs.

Official Title
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Determination of Effectiveness of SilverHawk Peripheral Plaque Excision (SilverHawk Device) for the Treatment of Infrainguinal Vessels/Lower Extremities

Conditions
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Claudication, Peripheral Arterial Disease, Critical Limb Ischemia

Intervention / Treatment
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* Device: SilverHawk & TurboHawk Peripheral Plaque Excision System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Has a Rutherford Clinical Category Score of 1 - 6. Has evidence of ≥ 50% stenosis or occlusion in the superficial femoral, popliteal, anterior tibial, posterior tibial and/or peroneal arteries, confirmed by angiography. Has identifiable distal target vessel which upon completion of the intervention, is anticipated to provide re-constitution of blood flow to the foot. Exchangeable guidewire must cross lesion(s), with ability of catheter to cross lesion. Each discrete target lesion's length is ≤ 20 cm. Reference vessel diameter is ≥ 1.5 mm and ≤ 7 mm. Exclusion Criteria Has surgical or endovascular procedure of the target vessel within 14 days prior to the index procedure. Has any planned surgical intervention or endovascular procedure within 30 days after the index procedure. Has had a previous peripheral bypass affecting the target limb. Has end-stage renal disease defined as undergoing hemodialysis for kidney failure. Has presence of severe calcification in target lesion(s). Has in-stent restenosis of the target lesion. Has an aneurysmal target vessel. Has significant stenosis or occlusion of inflow tract that has not been revascularized prior to treatment of the target vessel. Has perforation, dissection or other injury of the access or target vessel requiring additional stenting or surgical intervention prior to enrollment. Has disease that precludes safe advancement of the SilverHawk/TurboHawk device to the target lesion(s). Has had a previous amputation above the metatarsal line on the target limb.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Atherectomy<br>All patients enrolled in this single-arm study were treated with directional atherectomy. | Device: SilverHawk & TurboHawk Peripheral Plaque Excision System<br>* Removal of atherosclerotic plaque from artery walls.<br>* Other names: SilverHawk (Atherectomy), TurboHawk (Atherectomy);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Patency Rate (in Patients Treated for Claudication RCC 1-3) | The primary endpoint analysis for claudication subjects was primary patency rate at one year, defined by duplex ultrasound measurement of peak systolic velocity ratio ≤ 3.5 at the target lesion(s) with no clinically-driven reintervention within the treated segment in subjects who had claudication (RCC of 1 - 3) at time of enrollment. | One year | 
| Amputation-Free Survival at 1 Year (in Patients Treated for Critical Limb Ischemia RCC 4-6) | The primary endpoint for CLI was amputation-free survival at one year, defined as freedom from a major, unplanned amputation of the target limb through the 1-year visit in subjects who have CLI (RCC 4 - 6) at time of enrollment. | One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Success (in All Patients Enrolled) | Device success was defined as ≤ 30% residual stenosis following use of the SilverHawk device, as measured by angiography, without adjunctive endovascular interventions or periprocedural complications. | Immediately following use of the SilverHawk device | 
| Procedural Success (in All Patients Enrolled) | Procedure success was defined as ≤ 30% residual stenosis following use of SilverHawk device and adjunctive endovascular interventions (if required) as measured by angiography without periprocedural complications. | Immediately following use of the SilverHawk and adjunctive devices | 
| Major Adverse Event Rate (in All Patients Enrolled) | Major Adverse Event Rate (MAE) at 30 Days was defined as clinically-driven target vessel revascularization (TVR), major unplanned amputation of treated limb, or all-cause mortality within 30 days post procedure, as classified by the Clinical Events Committee (CEC). | 30 Days | 
| Major Adverse Event Rate (in All Patients Enrolled) | Major Adverse Event Rate at One Year was defined as clinically-driven target vessel revascularization, major unplanned amputation of the treated limb, or all-cause mortality within one year, as classified by the Clinical Events Committee (CEC). | One Year | 
| Improvement in Walking Impairment Questionnaire Score (in Patients Treated for Claudication RCC 1-3) | WIQ includes a measurement for walking distance, walking speed, and climbing stairs collected at baseline and one year, presented for subjects who have claudication. The Walking Improvement Questionnaire (WIQ) is a validated method to assess objective improvement in functional walking ability of subjects with intermittent claudication. Difficulty walking a distance was self-assessed at baseline by the patient (prior to treatment) and at the one year follow up visit. Speed and stair climbing ability were assessed by the treating physician. Scale ranges from 0 (minimum) to 100 (maximum), with larger numbers representing better outcomes. An increase in WIQ scores at 1 year represents an improvement over baseline. | Baseline and 1 Year | 
| Improvement in Rutherford Clinical Category (in All Patients Enrolled) | Change in RCC at One Year was assessed and percentage of subjects with an improvement in clinical status indicated by a decrease of one or more in RCC at one year compared to baseline, that is attributable to the treated limb (in cases of bilateral disease), was calculated. | 1 Year | 
| Ankle-Brachial Index (in All Patients Enrolled) | Change in Ankle-Brachial Index at One Year was calculated and percentage of subjects with an increase (improvement) in the ankle-brachial index (ABI) at one year compared to baseline in subjects with compressible arteries and baseline ABI < 0.9 was calculated. | 1 Year | 
| Secondary Patency (in Patients Treated for Claudication RCC 1-3) | Secondary patency was defined as measured by duplex ultrasound peak systolic velocity ratio ≤ 3.5 maintained by repeat percutaneous intervention in subjects who have claudication; estimated as freedom from loss of patency by the Kaplan-Meier method at one year. | One Year | 
| Primary Patency (in Patients Treated for Critical Limb Ischemia RCC 4-6) | The primary patency for CLI was defined by duplex ultrasound measurement of peak systolic velocity ratio ≤ 3.5 at the target lesion(s) with no clinically-driven reintervention within the treated segment in subjects who have CLI at time of enrollment | One Year | 
| Amputation-Free Survival (in Patients Treated for Claudication RCC 1-3) | Amputation-Free Survival in Claudicants at One Year was defined as freedom from a major, unplanned amputation of the target limb through the one year visit in subjects who have claudication at time of enrollment. | One Year | 
| Improvement in Wound Healing (in Patients Treated for Critical Limb Ischemia and With Wounds RCC 5-6) | Wound healing at three months was defined as a decrease of at least one Wagner Classification grade of the wound at three months compared to baseline in subjects who have Rutherford Clinical Category score of 5 or 6 at the time of enrollment. | 3 months | 
| Alternative Patency Rate (Peak Systolic Velocity ≤ 2.4) at 1 Year (in Patients Treated for Claudication RCC 1-3) | Defined by the duplex ultrasound measurement of peak systolic velocity ration ≤ 2.4 at the target lesion (s) with no clinically-driven re- intervention with the treated segment in subjects who have claudication at time of enrollment. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAD