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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date June 2020
Source Volcano Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.


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.


Recruitment information / eligibility

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.

Study Design


Intervention

Device:
Atherectomy
Selectively cut and remove atheromatous plaque in the lower extremities. Debulking and removal of atherosclerotic burden plaque with Phoenix Atherectomy System.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Volcano Corporation

Country where clinical trial is conducted

United States, 

Outcome

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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