Peripheral Arterial DiseaseNCT02475200
Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems
An observational study of Peripheral Arterial Disease and Claudication, run by Volcano Corporation at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Claudication, Critical Limb Ischemia
- What is being tested?
- Atherectomy
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 Sep 2015to 29 May 2020
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include patients who are scheduled to receive atherectomy with the Phoenix Atherectomy System used according to local standards.
Who may be able to join
- 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.
Who cannot join
- Patients who have ANY of the following exclusion criteria are NOT eligible for the study:
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cardiovascular Specialists of Texas
Austin, Texas, 78758
St. John Hospital
Detroit, Michigan, 48236
Jackson Heart Clinic
Jackson, Mississippi, 39216
Mid-Michigan Heart & Vascular Center
Saginaw, Michigan, 48604
Pima Vascular
Tucson, Arizona, 85718
About this study
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.
Read the 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.
- Being tested
- Atherectomy
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtherectomyDevice
Selectively cut and remove atheromatous plaque in the lower extremities. Debulking and removal of atherosclerotic burden plaque with Phoenix Atherectomy System.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 days
Secondary outcomes (7)
Ankle brachial index (ABI)
Change in ABI between baseline and 12-month follow-up visits in patients with CLI at baseline
Measured: 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
Measured: 12 months
Rutherford Clinical Category
Change in Rutherford Clinical Category between baseline and 12-month follow-up visits in patients with CLI at baseline
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study start14 Sep 2015
- Primary completion8 Apr 2018
- Study completion29 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Volcano Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bradley S Matsubara, MD, Study director, Volcano Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475200
- Sponsor's protocol ID
- 150201
- Status last verified
- Jun 2020
- First submitted
- 8 Apr 2015
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems
- ClinicalTrials.gov ID
- NCT02475200
- Acronym / sponsor ID
- 150201
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Volcano CorporationIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2015 (actual)
- Primary completion
- 8 Apr 2018 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include patients who are scheduled to receive atherectomy with the Phoenix Atherectomy System used according to local standards.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients who have ANY of the following exclusion criteria are NOT eligible for the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtherectomySelectively cut and remove atheromatous plaque in the lower extremities. Debulking and removal of atherosclerotic burden plaque with Phoenix Atherectomy System. | Device | – |
Primary outcome
Phoenix device performance
Time frame: 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)
7 secondary outcomes
Ankle brachial index (ABI)
Time frame: 12 months
Society for Vascular Surgery's Wound, Ischemia, and foot Infection (WIfI) category
Time frame: 12 months
Rutherford Clinical Category
Time frame: 12 months
Clinically-driven target vessel revascularization (TVR) in patients with CLI at baseline
Time frame: 12 months
Clinically-driven target lesion revascularization (TLR) in patients with CLI at baseline
Time frame: 12 months
Unplanned target limb amputation in patients with CLI at baseline
Time frame: 30 days
Unplanned target limb amputation in patients with CLI at baseline
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley S Matsubara, MD study director
Volcano Corporation
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Claudication, run by Volcano Corporation at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phoenix device performance (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.