Clinical trial NCT02475200: Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems
Official title: Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Claudication
Critical Limb Ischemia
Lead sponsor: Volcano Corporation
Sponsor class: INDUSTRY
First posted: 2015-06-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Phoenix device performance
timeFrame: 30 days
Secondary outcomes:
measure: Ankle brachial index (ABI)
timeFrame: 12 months
measure: Society for Vascular Surgery's Wound, Ischemia, and foot Infection (WIfI) category
timeFrame: 12 months
measure: Rutherford Clinical Category
timeFrame: 12 months
measure: Clinically-driven target vessel revascularization (TVR) in patients with CLI at baseline
timeFrame: 12 months
measure: Clinically-driven target lesion revascularization (TLR) in patients with CLI at baseline
timeFrame: 12 months
measure: Unplanned target limb amputation in patients with CLI at baseline
timeFrame: 30 days
measure: Unplanned target limb amputation in patients with CLI at baseline
timeFrame: 12 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Pima Vascular
state: Arizona
city: Detroit
country: United States
facility: St. John Hospital
state: Michigan
city: Saginaw
country: United States
facility: Mid-Michigan Heart & Vascular Center
state: Michigan
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Austin
country: United States
facility: Cardiovascular Specialists of Texas
state: Texas
Study officials:
affiliation: Volcano Corporation
name: Bradley S Matsubara, MD
role: STUDY_DIRECTOR
References: