The Complete® SE SFA Study for the Treatment of SFA/PPA Lesions

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of the Complete SE SFA Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD).

Detailed Description
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The Complete Self-Expanding (SE) SFA Stent is designed to be a permanent implant. It is cut from a nickel titanium alloy (Nitinol) tube and consists of a series of segments each connected to the next in a unique pattern to allow for flexibility and vessel conformability. Each segment consists of two struts and a crown (Figure 1). It is designed to produce optimal luminal diameter and increased scaffolding, and to maintain luminal patency.

Official Title
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The Complete® SE SFA Study: The Medtronic Complete Self-Expanding SFA Stent System for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and/or Proximal Popliteal Arteries

Conditions
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Peripheral Vascular Disease

Intervention / Treatment
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* Device: Complete SE Vascular Stent System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rutherford 2-4, with an occlusion or de novo and/or restenotic SFA/PPA lesion ≥50% and ankle-brachial index/toe-brachial index (ABI/TBI) <0.90/0.80. Target lesion located at least 1 cm distal to the take-off of the profunda femoris artery and at least 3 cm proximal to the highest point of the cortical margin of the femur; Target vessel reference diameter is ≥4.0 mm and ≤7.0 mm (visual estimate); Target lesion length is ≥4.0 cm and ≤14.0 cm (visual estimate); Adequate distal run-off to the ankle in the target limb (defined as having at least one patent calf vessel <50% stenosed; Life expectancy >12 months. Exclusion Criteria: Women who do not have a negative serum or urine pregnancy test documented within 7 days prior to enrollment; Any condition that precludes safe access with percutaneous transluminal angioplasty (PTA) devices, such as: excessive peripheral artery disease, unresolved fresh thrombus in the target lesion/vessel, or a target lesion/vessel that is excessively tortuous or calcified; Lesions in contralateral SFA/PPA that require intervention during the index procedure, or within 30 days before or after the index procedure; Previous treatment to the target lesion within the 3 months prior to enrollment; previous femoropopliteal bypass in target vessel; previous stenting of the target lesion; Target lesion located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion; Target lesion requires treatment other than standard PTA prior to stent placement (i.e., no other devices or procedures such as cutting balloons and laser atherectomy are permitted to be used during the index procedure); History of bleeding diatheses or coagulopathy or will refuse blood transfusions; Known impaired renal function, defined as creatinine >2.5 mg/dl; Known platelet count <80,000 cells/mm3 or >700,000 cells/mm3; Known white blood cell (WBC) of <3,000 cells/mm3; Participation in another investigational device or drug study and has not completed the primary endpoint(s) or which clinically interferes with the Complete SE SFA Study endpoints, or previously enrolled in the Complete SE SFA Study.

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 |
| --- | --- |
| Experimental: Complete SE Vascular Stent System<br>COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation. | Device: Complete SE Vascular Stent System<br>* Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Event (MAE) Rate | Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization. | 12 Months | 
| Primary Patency Rate | Primary patency defined as uninterrupted patency with no procedures performed on or at the margins of the treated segment, with no restenosis ≥ 50% as documented by peak systolic velocity ratio ≥2.0 as assessed by duplex ultrasound (DUS). | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Event (MAE) Rate | Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 30 day timepoint. | 30 days | 
| Major Adverse Event (MAE) Rate | Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 6 month timepoint. | 6 Months | 
| Device Success | The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device. | At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient). | 
| Lesion Success | The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using either the Complete SE SFA Stent System or other standard percutaneous devices. | At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient). | 
| Procedure Success | The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion after stent implantation and no occurrence of a procedure-related Major Adverse Events (MAE) prior to hospital discharge. | At time of deployment to time of hospital discharge | 
| Assisted Primary Patency | Defined as vessel patency resulting from a procedure performed in the treated segment. | 12 months | 
| Secondary Patency Rate | Defined as vessel patency resulting from any procedure that restores patency. | 12 Months | 
| Change in Quality of Life - Improvement in Rutherford Class by >= 1 Category | Improvement in Rutherford class by ≥ 1 category increase at 12 months from pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms). | 12 months | 
| Change in Quality of Life - Increase in Ankle-brachial Index (ABI) or Toe-brachial Index (TBI) >= 0.15 | Increase in ABI/TBI ≥ 0.15 at 12 months from pre-procedure. An increase in ABI/TBI of 0.15 or greater is considered by clinicians to be a significant improvement. | 12 Months | 
| Change in Quality of Life - Decrease in Rutherford Class >= 1 Category | Decline in Rutherford class ≥ 1 category at 30 days when compared to pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms). | 30 Days | 
| Percentage of Participants Free From Strut Fractures | Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up. | 12 Months | 
| Clinically-driven Target Lesion Revascularization (TLR) Rate | Defined as those revascularizations in which the subject has ischemic symptoms consistent with changes within the target lesion as demonstrated by: a change (decrease from post-procedure) in the Rutherford scale by at least one category, or a change (decrease from post-procedure) in ABI/TBI >= 0.15 | 12 Months | 
| Major Adverse Event (MAE) Rate | Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 24 month timepoint. | 24 Months | 
| Percentage of Participants Free From Strut Fractures | Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up at the 24 month timepoint. | 24 Months | 
| Major Adverse Event (MAE) Rate | Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 36 month timepoint. | 36 Months | 
| Percentage of Participants Free From Strut Fractures | Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up at the 36 month timepoint. | 36 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAD, peripheral arterial disease, stent, SFA, PPA