JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions

Data not available yet.

Inclusion criteria

• Subject is 18 years of age or older.
• Subject presents with clinical evidence of peripheral arterial disease with ISR in the femoropopliteal segment (includes common femoral, superficial femoral and popliteal)
• Subject presents with a Rutherford Classification of 1-5 and has symptoms of rest limb pain, ulcerations or claudication.
• Target lesion(s) must be viewed angiographically and have ≥50% stenosis.
• The atherectomy wire must be placed entirely across all lesions to be treated with no visible evidence of clear or suspected subintimal/substent wire passage.
• The main target vessel reference diameter must be at least 5 mm.
• One patent distal run-off vessel with brisk flow is required.
• Patient is an acceptable candidate for percutaneous intervention using the Jetstream NAVITUS System in accordance with its labeled instructions for use.
• Patient has signed approved informed consent.
• Patient is willing to comply with the follow-up evaluations at specified times.

Exclusion criteria

• Subject is unable to understand the study or has a history of non-compliance with medical advice.
• Subject is unwilling or unable to sign the Informed Consent Form (ICF).
• Subject is currently enrolled in another clinical investigational study that might clinically interfere with the current study endpoints (e.g., limit use of study-recommended medications, etc.).
• Subject is pregnant or planning to become pregnant within the study period.
• Subject has a known sensitivity to contrast media and the sensitivity cannot be adequately pre-medicated for.
• Subject is diagnosed with chronic renal failure or has a creatinine level > 2.5 mg/dl and is not on chronic dialysis.
• Subject has a known allergy to heparin, ASA, Plavix.
• Subject has a history of bleeding disorders or platelet count < 80,000 cells/ml.
• Subject experiences ongoing cardiac problems (e.g., cardiac arrhythmias, congestive heart failure exacerbation, myocardial infarction, etc.) that, per the investigator, would not make the subject an ideal candidate for study procedures.
• Subject has a CVA or TIA within 4 weeks prior to JetStream procedure.
• Subject has an anticipated life span of less than 6 months.
• Subject is suspected of having an active systemic infection.
• Subject per the investigator's medical judgment must be excluded from the study.
• Limited vascular access that precludes safe advancement of the Jetstream NAVITUS System to the target lesion(s).
• 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 any planned surgical intervention or endovascular procedure within 15 days after the index procedure.
• Use of another debulking device during the index procedure prior to the Jetstream NAVITUS System.
• Use of another debulking device after the Jetstream NAVITUS system.

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