Peripheral Arterial Disease Clinical Trial
Official title:
Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems
The Phoenix Post-Approval Registry is a prospective, multi-center, single arm registry sponsored by Volcano Corporation to evaluate the short and long term performance and clinical outcomes of the Phoenix Atherectomy System.
The Phoenix Post-Approval Registry is an prospective, multi-center, single arm registry,
sponsored by Volcano Corporation, to evaluate the short and long term performance and
clinical outcomes of the Phoenix Atherectomy System. The study includes consecutive patients
treated with the Phoenix Atherectomy System in a post-market (commercial device use) setting.
Patients will be followed under real-world conditions for up to 12 months after the index
procedure.
All patients with a planned endovascular revascularization procedure receiving treatment with
the Phoenix Atherectomy System as all or part of their PAD treatment strategy may be
included. Written informed consent must be obtained from each patient prior to enrollment in
the study. Enrolled patients will undergo PAD treatment that includes Phoenix atherectomy,
according to institutional or local standard of care. Data collection will include medical
record review of procedures performed according to standard of care.
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