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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Claudication; Critical Limb Ischemia
• Intervention / Treatment: Device: Atherectomy

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.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85718
      • Pima Vascular
  • Michigan
    • Detroit, Michigan, United States, 48236
      • St. John Hospital
    • Saginaw, Michigan, United States, 48604
      • Mid-Michigan Heart & Vascular Center
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Jackson Heart Clinic
  • Texas
    • Austin, Texas, United States, 78758
      • Cardiovascular Specialists of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study will include patients who are scheduled to receive atherectomy with the Phoenix Atherectomy System used according to local standards.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ankle brachial index (ABI)	Change in ABI between baseline and 12-month follow-up visits in patients with CLI at baseline	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	12 months
Rutherford Clinical Category	Change in Rutherford Clinical Category between baseline and 12-month follow-up visits in patients with CLI at baseline	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)	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)	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	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	12 months

Collaborators and Investigators

• Sponsor: Volcano Corporation
• Investigators: Study Director: Bradley S Matsubara, MD, Volcano Corporation

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2015
• Primary Completion (Actual): April 8, 2018
• Study Completion (Actual): May 29, 2020

Study Registration Dates

• First Submitted: April 8, 2015
• First Submitted That Met QC Criteria: June 15, 2015
• First Posted (Estimate): June 18, 2015

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 5, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 150201