The Jetstream (JET) Post-market Registry

Study Overview
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Brief Summary
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The scope of the JET registry to observe long term treatment effects of Jetstream Navitus on various lesions types/morphologies.

Detailed Description
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To observe the treatment effects of the Jetstream NAVITUS System in long, occluded, diffuse, thrombotic or calcified lesions in peripheral arterial disease of the common femoral, superficial femoral, or popliteal arteries. To assess and quantify vessel patency 1 year post atherectomy treatment.

Official Title
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Jetstream NAVITUS™ System Endovascular Therapy Post-market Registry (JET)

Conditions
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Peripheral Arterial Diseases

Intervention / Treatment
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* Device: Jetstream Atherectomy System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is ≥ 18 years of age. The target de novo or restenotic Percutaneous Transluminal Angioplasty (PTA) lesion(s) is/are located in the common femoral, superficial femoral or popliteal arteries. The reference vessel lumen (proximal to target lesion) is ≥ 4.0mm. Evidence of ≥ 70% stenosis or occlusion confirmed by angiography. Guidewire must cross lesion(s) within the true lumen, without a sub-intimal course before the patient is considered as entered into the study. Patient is an acceptable candidate for percutaneous intervention using the Jetstream NAVITUS System in accordance with its labeled indications and instructions for use. Lesion length ≥ 4cm. Patient has a Rutherford category score of 1-3. Patient has signed approved informed consent. Patient is willing to comply with the follow-up evaluations at specified times. 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 patent distal runoff vessels. Patient has critical limb ischemia (i.e., Rutherford class 4-6) Limited vascular access that precludes safe advancement of the Jetstream NAVITUS System to the target lesion(s). Interventional treatment is intended for in-stent restenosis. 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 significantly 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 has had surgical or endovascular procedure in the same vascular territory within 30 days prior to the index procedure. Patient has any planned surgical intervention or endovascular procedure within 30 days after the index procedure. Use of another debulking device during the index procedure prior to the Jetstream NAVITUS System will exclude the patient.

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: Jetstream Atherectomy System<br>Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy. | Device: Jetstream Atherectomy System<br>* Atherectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binary Restenosis | Percentage of patients with binary restenosis at 12 months as defined by duplex ultrasound derived systolic velocity ratio >2.5. Binary restenosis will be measured by duplex ultrasound technology. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success | Percentage of patients with successful revascularization of target vessel defined as ≤ 30% residual diameter stenosis following atherectomy +/- adjunctive therapy | Index Procedure | 
| Ankle-Brachial Index (ABI) | Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm. | 30 days | 
| Ankle-Brachial Index (ABI) | Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm. | 6 months | 
| Ankle-Brachial Index (ABI) | Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm. | 12 months | 
| Major Adverse Events (MAE) | Number of Major Adverse Events as defined by amputation, death, Target Lesion Revascularization, Target Vessel Revascularization, Myocardial Infarction or angiographic distal embolization that requires a separate intervention or hospitalization through 30 days | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAD, peripheral artery disease, atherectomy