Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems

Peripheral Arterial Disease Clinical Trial

Official title:

Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02475200
• Other study ID #: 150201
• Status: Completed
• Start date: September 14, 2015
• Est. completion date: May 29, 2020

Study information

• Verified date: June 2020
• Source: Volcano Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 29, 2020
• Est. primary completion date: April 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Claudication
• Critical Limb Ischemia
• Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Atherectomy
Selectively cut and remove atheromatous plaque in the lower extremities. Debulking and removal of atherosclerotic burden plaque with Phoenix Atherectomy System.

Locations

Country	Name	City	State
United States	Cardiovascular Specialists of Texas	Austin	Texas
United States	St. John Hospital	Detroit	Michigan
United States	Jackson Heart Clinic	Jackson	Mississippi
United States	Mid-Michigan Heart & Vascular Center	Saginaw	Michigan
United States	Pima Vascular	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Volcano Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ankle brachial index (ABI)	Change in ABI between baseline and 12-month follow-up visits in patients with CLI at baseline	12 months
Secondary	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
Secondary	Rutherford Clinical Category	Change in Rutherford Clinical Category between baseline and 12-month follow-up visits in patients with CLI at baseline	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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