Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems
Status: | Enrolling by invitation |
---|---|
Conditions: | Peripheral Vascular Disease, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/18/2018 |
Start Date: | September 14, 2015 |
End Date: | September 2019 |
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.
sponsored by Volcano Corporation to evaluate the short and long term performance and clinical
outcomes of the Phoenix Atherectomy System.
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.
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.
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.
We found this trial at
5
sites
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