An observational study in Peripheral Arterial Disease, Claudication and Critical Limb Ischemia, sponsored by Volcano Corporation. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-09.
Sponsored by Volcano Corporation · Observational
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.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 500 is above the median of 190 across 410 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Volcano Corporation is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study will include patients who are scheduled to receive atherectomy with the Phoenix Atherectomy System used according to local standards.
Exclusion Criteria:
Patients who have ANY of the following exclusion criteria are NOT eligible for the study:
Selectively cut and remove atheromatous plaque in the lower extremities. Debulking and removal of atherosclerotic burden plaque with Phoenix Atherectomy System.
Phoenix device performance
Rates of TECHNICAL SUCCESS (ratio of Phoenix treated lesions with \<=50% residual diameter stenosis to all Phoenix treated lesions); and PROCEDURAL SUCCESS (ratio of target lesion residual stenosis of \<=30% after treatment with Phoenix and adjunctive treatments to all treated lesions)
Time frame: 30 days
Ankle brachial index (ABI)
Change in ABI between baseline and 12-month follow-up visits in patients with CLI at baseline
Time frame: 12 months
Society for Vascular Surgery's Wound, Ischemia, and foot Infection (WIfI) category
Change in WIfI category between baseline and 12-month follow-up visits in patients with CLI at baseline
Time frame: 12 months
Rutherford Clinical Category
Change in Rutherford Clinical Category between baseline and 12-month follow-up visits in patients with CLI at baseline
Time frame: 12 months
Clinically-driven target vessel revascularization (TVR) in patients with CLI at baseline
Rate of repeat percutaneous (endovascular) or surgical intervention to treat objectively documented signs/symptoms of recurrent ischemia attributable to the target vessel at a site other than the index lesion(s)
Time frame: 12 months
Clinically-driven target lesion revascularization (TLR) in patients with CLI at baseline
Rate of repeat percutaneous (endovascular) or surgical intervention to treat objectively documented signs/symptoms of recurrent ischemia attributable to the index lesion(s)
Time frame: 12 months
Unplanned target limb amputation in patients with CLI at baseline
Rate of amputation associated with the target limb that occurs between the index procedure and 30 days that was not previously planned as part of the overall treatment strategy
Time frame: 30 days
Unplanned target limb amputation in patients with CLI at baseline
Rate of amputation associated with the target limb that occurs between the index procedure and 12 months that was not previously planned as part of the overall treatment strategy
Time frame: 12 months
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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