Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems

Completed

• Conditions: Peripheral Arterial Disease; Claudication; Critical Limb Ischemia

• Registration Number: NCT02475200
• Lead Sponsor: Volcano Corporation

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.

Study Timeline

• Study First Submitted: 2015-04-08
• Study First Submitted QC: 2015-06-15
• Study First Posted: 2015-06-18
• Study Start: 2015-09-14
• Primary Completion: 2018-04-08
• Study Completion: 2020-05-29
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-05
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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)
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
Unplanned target limb amputation in patients with CLI at baseline	12 months	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

Trial Locations

Locations (5)

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