JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions
United States29 participantsStarted 2012-10
Plain-language summary
Several studies have shown that stenting of the femoropopliteal artery in the lower leg leads to improved overall results compared to balloon angioplasty alone. However, scar tissue development can occur within the stent, a process called restenosis. Treatment of these in-stent restenotic lesions has a high procedural success rate but recurrence of scar tissue is frequently seen. Several methods have been proposed to treat in-stent restenosis in the lower leg arteries but mixed results have been noted. In this study we hypothesize that simultaneous tissue excision and aspiration using the JetStream Navitus device (Medrad) can lead to a high rate of acute procedural success with low intraprocedural complications and an acceptable recurrence rate of restenosis at 6-month follow-up.
Who can participate
Age range18 Years
SexALL
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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.
. 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.