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Completed

NCT Number: NCT02475200

Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Claudication Critical Limb Ischemia Disease Attributes Intermittent Claudication Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pima Vascular, Tucson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

atherectomy

Device

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Ankle brachial index (ABI)

    Time frame: 12 months

    Change in ABI between baseline and 12-month follow-up visits in patients with CLI at baseline

  2. Society for Vascular Surgery's Wound, Ischemia, and foot Infection (WIfI) category

    Time frame: 12 months

    Change in WIfI category between baseline and 12-month follow-up visits in patients with CLI at baseline

  3. Rutherford Clinical Category

    Time frame: 12 months

    Change in Rutherford Clinical Category between baseline and 12-month follow-up visits in patients with CLI at baseline

  4. Clinically-driven target vessel revascularization (TVR) in patients with CLI at baseline

    Time frame: 12 months

    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)

  5. Clinically-driven target lesion revascularization (TLR) in patients with CLI at baseline

    Time frame: 12 months

    Rate of repeat percutaneous (endovascular) or surgical intervention to treat objectively documented signs/symptoms of recurrent ischemia attributable to the index lesion(s)

  6. Unplanned target limb amputation in patients with CLI at baseline

    Time frame: 30 days

    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

  7. Unplanned target limb amputation in patients with CLI at baseline

    Time frame: 12 months

    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

Sponsors and collaborators

Lead sponsor

Volcano Corporation

Industry

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Jun 18, 2015
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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