A Safety and Effectiveness Study of the MD-12-001 Stent in the Treatment of Superficial Femoral Artery or Popliteal Artery Blockages in Japanese Patients

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and effectiveness of the MD-12-001 stent in the treatment of superficial femoral artery and proximal popliteal artery blockages in Japanese patients.

Official Title
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A Single Arm Clinical Trial in Japan for Reconstruction of Obstructive Lesions of the Superficial Femoral Artery or Proximal Popliteal Artery by Bard LifeStent.

Conditions
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Arterial Occlusive Disease

Intervention / Treatment
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* Device: MD-12-001 Stent


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Rutherford Category 2-4 (mild intermittent claudication (pain while walking)to ischemic pain (pain due to decreased blood flow) at rest). The target lesion(s) has evidence of narrowing or blockage and can be stented. The total length of the lesion or series of lesions is estimated to be less than or equal to 150 mm. The target vessel reference diameter is greater than or equal to 4.0 mm and less than or equal to 6.5 mm Key Exclusion Criteria: The subject has a known reaction (including allergic reaction) or sensitivity to blood thinning medications, or study device materials (nickel, titanium or tantalum) The subject has a known sensitivity to medical imaging substances (contract media) that cannot be pretreated with medications (steroids or/and antihistamines) The subject has a history of bleeding disorders (diatheses or coagulopathy). The subject has kidney failure or is having dialysis treatment. The subject has insufficient liver function, swelling of vein(s) caused by blood clot (thrombophlebitis), uremia, systemic lupus, or deep vein blood clots. Subject has Acute Limb Ischemia (a sudden loss of blood flow to the limb). Subject has a history of bypass surgery on the study vessel. Subject has a history of heart attack or stroke within 6 months of study procedure. The subject is receiving immunosuppressive therapy (medications that lower the body's normal immune response). The subject is diagnosed with a severe infection (septicemia). Principal investigator determines the subject's condition would prevent the subject from undergoing the study procedure or cannot support a vascular bypass graft. The subject with a stent previously implanted into the target vessel. Subject has disease in both legs where both limbs meet the inclusion criteria and it is planned to treat both limbs within 30 days. Pregnant, possibly pregnant and/or nursing female subjects are excluded, as are female subjects who are willing to have a baby during the trial. The subject is participating in an investigational drug or another investigational device study. Subject has a large amount of blood clot next to the study lesion.

Ages Eligible for Study
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Minimum Age: 20 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: MD-12-001 Stent Arm<br>This study includes a single arm, the MD-12-001 Stent Arm. | Device: MD-12-001 Stent<br>* MD-12-001 is a self-expanding nitinol stent<br>* Other names: Bard Lifestent Vascular Stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects who are free of target limb failure at 12-months post study procedure. |  | 12-months post study procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects who are free of target limb failure. |  | 30-days, 6-, 24-, and 36-months post study procedure | 
| The proportion of subjects with primary target lesion patency. | This endpoint will assess whether the study blockage has been unblocked using ultrasound imaging assessments reviewed by an independent core laboratory. | 30-days, 6-, 12-, 24-, and 36-months post study procedure | 
| The proportion of subjects with secondary target vessel/lesion patency. | This endpoint will assess whether the study blockage has shut again; where the target vessel/lesion no longer has blood flow or where surgical bypass of the vessel is performed. | 30-days, 6-, 12-, 24-, and 36-months post study procedure | 
| Proportion of subjects who achieve acute procedural success. |  | Perioperative period (period during study procedure) | 
| Rutherford category assessment. | The assessment of peripheral artery disease severity will be performed using the Rutherford Classification system. | Baseline, 30-days. 3-. 6-. 12-. 24-. 36-. 48- and 60-months post study procedure | 
| Ankle-brachial index measurements. | The ratio of blood pressure in the lower legs to the blood pressure in the arms will be calculated and assessed as a measure of disease severity. | Baseline, 30-days, 3-, 6-, 12-, 24-, 36-, 48-, and 60-months post study procedure | 
| Quality of Life (SF-36) Questionnaire | The SF-36 Quality of Life Questionnaire (QOL) will be used to evaluate QOL changes during study participation. | Baseline, 30-days, 3- , 6-, 12-, 24-, 36-, 48-, and 60-months post study procedure | 
| Proportion of Subjects who experience Major Adverse Events. | Major Adverse Events is defined as any death, stroke, myocardial infarction (heart attack) or target limb amputation. | 30-days post procedure | 
| Proportions of Subjects who experience 1) any adverse event and 2) any serious adverse event. |  | through 60-months post study procedure | 
| The proportion of subjects who undergo target vessel/lesion revascularization (restoration of blood flow) |  | 12-, 24-, 36-, 48-, and 60-months post study procedure | 
| Proportion of subjects without stent fracture |  | 30-days, 6-, 12-, 24, and 36-months post study procedure |