Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems

Volcano

Status: Completed

Conditions: Claudication; Critical Limb Ischemia; Peripheral Arterial Disease

Treatments: Device: Atherectomy

Study type: Observational

Funder types: Industry

Identifiers

NCT02475200

150201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 exclusion criteria are NOT eligible for the study:

  1. Patients unwilling or unable to comply with the protocol including 12-month follow-up for patients with CLI at baseline.
  2. Patient is participating in another device or drug clinical trial that interferes with this protocol follow up schedule.