Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems

Completed

Conditions studied: Peripheral Arterial Disease, Claudication, Critical Limb Ischemia

In brief

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.

Key facts

Study ID

NCT02475200

Run by

Volcano Corporation

People needed

500

Starts

2015-09-14

Expected to finish

2020-05-29

Last updated by the study team

2020-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient is ≥18 years of age.
• Patient understands the research nature of the study and is willing and capable of providing written informed consent.
• Scheduled for and receives treatment with the Phoenix Atherectomy System as all or part of their PAD treatment.
• Meets Phoenix Atherectomy System catheter Instruction for Use (IFU) criteria.

You may not qualify if…

• Patients who have ANY of the following exclusion criteria are NOT eligible for the study:
• Patients unwilling or unable to comply with the protocol including 12-month follow-up for patients with CLI at baseline.
• Patient is participating in another device or drug clinical trial that interferes with this protocol follow up schedule.

Where it is running

• Pima Vascular — Tucson, Arizona, United States
• St. John Hospital — Detroit, Michigan, United States
• Mid-Michigan Heart & Vascular Center — Saginaw, Michigan, United States
• Jackson Heart Clinic — Jackson, Mississippi, United States
• Cardiovascular Specialists of Texas — Austin, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.