Peripheral Arterial Disease Clinical Trial
Official title:
Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems
NCT number | NCT02475200 |
Other study ID # | 150201 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 14, 2015 |
Est. completion date | May 29, 2020 |
Verified date | June 2020 |
Source | Volcano Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Volcano Corporation |
United States,
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 |
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