The Jetstream G3™ Calcium Study

Study Overview
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Brief Summary
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To investigate the treatment effects with the Jetstream G3 System in moderate to severely calcified peripheral artery disease in the common femoral, superficial femoral or popliteal arteries using intravascular ultrasound (IVUS).

Official Title
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A Prospective, Single-Arm Study to Evaluate the Effects of the Jetstream G3 System on Calcified Peripheral Vascular Lesions

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Jetstream Atherectomy System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is ≥ 18 years of age. Patient has claudication determined to be due to femoropopliteal lesion(s) requiring revascularization. The target lesion(s) is/are located in the common femoral, superficial femoral or popliteal arteries. The reference vessel lumen (proximal to target lesion) is ≥ 3.0mm. The patient is an acceptable candidate for percutaneous intervention using the Jetstream G3 System in accordance with its labeled indications and instructions for use. The patient has signed approved informed consent. Moderate or severe vessel obstructive intraluminal calcification as demonstrated by IVUS and angiography. Exclusion Criteria: Patient has an uncontrollable allergy to nitinol, stainless steel or other stent materials or to contrast agent. Patient is unable to take appropriate anti-platelet therapy. Patient has no distal runoff vessels. Deep wall calcium. Interventional treatment is intended for in-stent restenosis at the peripheral vascular site. Patient has target vessel with moderate or severe angulation (e.g., >30 degrees) or tortuosity at the treatment segment. Patient has a history of coagulopathy or hypercoagulable bleeding disorder. Patient is receiving hemodialysis or has impaired renal function (creatinine is > 2.5 mg/dl) at the time of treatment. Patient has evidence of intracranial or gastrointestinal bleeding within the past 3 months. Patient has had severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days. Patient is pregnant or nursing a child. Intended interventional treatment includes planned laser, brachytherapy or atherectomy procedure other than the Jetstream G3 System. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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: Patients with PAD<br>Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention who have moderate to severe obstructive intraluminal calcium | Device: Jetstream Atherectomy System<br>* to perform atherectomy on calcified lesions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Luminal Area Change | lumen area change as measured by intravascular ultrasound (IVUS) | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjunctive Therapy Use |  | Day 0 | 
| Residual Diameter Stenosis | lumen diameter stenosis change post-atherectomy | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAD, Peripheral Arterial Disease, Calcium, Atherectomy, Jetstream