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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).
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Inclusion criteria
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.
Primary purpose
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55 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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