Claudication, Critical Limb Ischemia, Peripheral Arterial Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAtherectomy
Selectively cut and remove atheromatous plaque in the lower extremities. Debulking and removal of atherosclerotic burden plaque with Phoenix Atherectomy System.
Sponsors
Volcano Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient is ≥18 years of age. 2. Patient understands the research nature of the study and is willing and capable of providing written informed consent. 3. Scheduled for and receives treatment with the Phoenix Atherectomy System as all or part of their PAD treatment. 4. Meets Phoenix Atherectomy System catheter Instruction for Use (IFU) criteria.
Exclusion criteria
* Patients who have ANY of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phoenix device performance | 30 days | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Society for Vascular Surgery's Wound, Ischemia, and foot Infection (WIfI) category | 12 months | Change in WIfI category between baseline and 12-month follow-up visits in patients with CLI at baseline |
| Rutherford Clinical Category | 12 months | Change in Rutherford Clinical Category between baseline and 12-month follow-up visits in patients with CLI at baseline |
| Ankle brachial index (ABI) | 12 months | Change in ABI between baseline and 12-month follow-up visits in patients with CLI at baseline |
| Clinically-driven target lesion revascularization (TLR) in patients with CLI at baseline | 12 months | Rate of repeat percutaneous (endovascular) or surgical intervention to treat objectively documented signs/symptoms of recurrent ischemia attributable to the index lesion(s) |
| Unplanned target limb amputation in patients with CLI at baseline | 30 days | 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 |
| Clinically-driven target vessel revascularization (TVR) in patients with CLI at baseline | 12 months | 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) |
Countries
United States
Outcome results
None listed