Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems
1 other identifier
observational
500
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2015
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2015
CompletedFirst Posted
Study publicly available on registry
June 18, 2015
CompletedStudy Start
First participant enrolled
September 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2020
CompletedJune 9, 2020
June 1, 2020
2.6 years
April 8, 2015
June 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Ankle brachial index (ABI)
12 months
Society for Vascular Surgery's Wound, Ischemia, and foot Infection (WIfI) category
12 months
Rutherford Clinical Category
12 months
Clinically-driven target vessel revascularization (TVR) in patients with CLI at baseline
12 months
Clinically-driven target lesion revascularization (TLR) in patients with CLI at baseline
12 months
- +2 more secondary outcomes
Interventions
Selectively cut and remove atheromatous plaque in the lower extremities. Debulking and removal of atherosclerotic burden plaque with Phoenix Atherectomy System.
Eligibility Criteria
This study will include patients who are scheduled to receive atherectomy with the Phoenix Atherectomy System used according to local standards.
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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Pima Vascular
Tucson, Arizona, 85718, United States
St. John Hospital
Detroit, Michigan, 48236, United States
Mid-Michigan Heart & Vascular Center
Saginaw, Michigan, 48604, United States
Jackson Heart Clinic
Jackson, Mississippi, 39216, United States
Cardiovascular Specialists of Texas
Austin, Texas, 78758, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bradley S Matsubara, MD
Volcano Corporation
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2015
First Posted
June 18, 2015
Study Start
September 14, 2015
Primary Completion
April 8, 2018
Study Completion
May 29, 2020
Last Updated
June 9, 2020
Record last verified: 2020-06