Endovascular Atherectomy Safety and Effectiveness Study (EASE)

A Prospective, Multicenter Clinical Evaluation of the Safety and Effectiveness of the Phoenix Atherectomy™ System in Atherectomy of the Peripheral Vasculature

The purpose of this study is to evaluate the procedural safety and effectiveness of the Phoenix Atherectomy™ System for the treatment of de novo and restenotic atherosclerotic lesions located in the native peripheral arteries. The Phoenix Atherectomy™ System is intended for use in atherectomy of the peripheral vasculature. The intended peripheral vessels include the Superficial Femoral, Popliteal, and Infrapopliteal arteries. The system is not intended for use in the coronary, carotid, iliac or renal vasculature. The results of this study will be used to support a 510(k) submission to the Food and Drug Administration.

Study Overview

• Status: Completed
• Conditions: Peripheral Vascular Disease
• Intervention / Treatment: Device: Phoenix Atherectomy System

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Bad Sackingen, Germany, 79713
    • Hochrhein-Eggberg-Klinik GmbH
  • Leipzig, Germany, 04289
    • Park-Hospital Leipzig
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Spring Hill Medical Center
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Arizona Heart Institute
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart Hospital
  • Florida
    • Pensacola, Florida, United States, 32504
      • Vascular Interventional Center
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital Midtown
    • Austell, Georgia, United States, 30106
      • Wellstar Health System
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Methodist Research Imstitute /Cobb Hospital
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Cardiovascular Institute of the South
    • Lafayette, Louisiana, United States, 70506
      • Cardiovascular Inst The Regional Med Center/Center of Acadia Institute of the South
  • Michigan
    • Detroit, Michigan, United States, 48236
      • St. John Hospital and Medical Center
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • New Jersey
    • Flemington, New Jersey, United States, 08822
      • Hunterdon Cardiovascular Associated
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center/New York Presbyterian
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • The Carl & Eduth Lindner Center for Research & Education at the Christ Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject willing and able to give informed consent
• Subject willing and able to comply with the study protocol
• Age ≥18 years old
• Objective hemodynamic criteria that subject has a resting ankle-brachial index (ABI) ≤ 0.90, or ≤ 0.75 after exercise, OR patients with non-compressible arteries (ABI>1.1) must have a toe-brachial index (TBI) of ≤ 0.80
• Clinical description of lesion as characterized by a Rutherford Clinical Class 2 to 5
• Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guideline
• Subject has target lesion/lesions defined as stenosis ≥ 70% as determined by operator visual assessment, distal to the profunda femoral artery. No more than two lesions may be treated with the Phoenix device and one of the treated lesions must include a lesion with the worst percent diameter stenosis.
• Total treated lesion length with the Phoenix device ≤ 10 cm
• Popliteal and above, target reference vessel diameter (proximal and distal to target lesion) is ≥ 2.5 mm and ≤ 4.5 mm
• At least one patent tibial vessel runoff at baseline.
• Below popliteal, target reference vessel diameter (proximal and distal to target lesion) is ≥ 2.5 mm and ≤ 3.5 mm

Exclusion Criteria:

• Patient has an active infection in the target limb
• Clinical/angiographic complication (other than non-flow limiting dissections) attributed to a currently marketed device prior to introduction of Phoenix System
• Critical limb ischemia with Rutherford Clinical Class 6
• Target lesion containing severe calcification that is circumferential and noted in two views
• Lesion in the contralateral limb requiring intervention during index procedure or within next 30 days
• In-stent restenosis within the target lesion
• Flow limiting dissection, Type C or greater
• Lesion within a native vessel graft or synthetic graft
• History of an endovascular procedure or open vascular surgery on the index limb within the last 30 days
• Subject has any planned surgical or interventional procedure within 30 days after the study procedure
• Significant acute or chronic kidney disease with a creatinine level >2.5 mg/dl, and/or requiring dialysis
• Unstable coronary artery disease or other uncontrolled comorbidity
• Myocardial infarction or stroke within 2 months of baseline evaluation
• Subject is pregnant or breast-feeding
• Participation in any study of an investigational device, medication, biologic, or other agent within 30 days prior to enrollment that is either a cardiovascular study or could, in the judgment of the investigator, affect the results of this study
• Subject has significant stenosis or occlusion of inflow tract (upstream disease) not successfully treated before this procedure
• Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated
• Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 125,000/microliter, known coagulopathy, or INR > 1.5
• Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated
• History of heparin-induced thrombocytopenia (HIT)
• Any thrombolytic therapy within two weeks of enrollment
• Psychiatric disorder which in the judgment of the investigator could interfere with provision of informed consent, completion of tests, therapy, or follow-up
• Clinical/angiographic evidence of distal embolization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Phoenix Atherectomy System

Device: Phoenix Atherectomy System; Evaluate the procedural safety and effectiveness of the Phoenix Atherectomy™ System for the treatment of de novo and restenotic atherosclerotic lesions located in native peripheral arteries as assessed through 30 day follow-up. Further evaluations of device performance ensuring no prostenotic response as assessed through six month follow-up.; Other Names: Atherectomy; Percutaneous Transluminal Atherectomy; Transluminal Atherectomy; Percutaneous Atherectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Freedom from Major Adverse Events		30 days
Efficacy: Technical Success	The achievement of acute debulking to achieve a post-Phoenix (prior to any adjunctive therapy) residual diameter stenosis of ≤50%.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Major Adverse Events		From 1 month to 6 months post procedure
Procedural success	Procedural success rate is defined as the proportion of the target lesions in which the final stenosis is <30% after treatment with atherectomy and any other adjunctive therapy.	Day 1
Clinical success	Clinical success rate is defined as the proportion of subjects that have procedural successes in all target lesions with achievement of at least one Rutherford Clinical Scale at 30 days and 6 months post procedure,	30 days to 6 months
Target vessel Revascularization	Incidence of clinically-driven target vessel revascularization or target limb revascularization.	Treatment through 6 months

Collaborators and Investigators

• Sponsor: AtheroMed, Inc
• Investigators: Principal Investigator: Thomas P Davis, MD, St. John Hospital & Medical Center; Principal Investigator: James McKinsey, MD, Columbia University Medical Center/New York Presbyterian

Publications and helpful links

General Publications

• Davis T, Ramaiah V, Niazi K, Martin Gissler H, Crabtree T. Safety and effectiveness of the Phoenix Atherectomy System in lower extremity arteries: Early and midterm outcomes from the prospective multicenter EASE study. Vascular. 2017 Dec;25(6):563-575. doi: 10.1177/1708538117712383. Epub 2017 Sep 27.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: August 4, 2010
• First Submitted That Met QC Criteria: February 29, 2012
• First Posted (Estimate): March 1, 2012

Study Record Updates

• Last Update Posted (Estimate): January 31, 2014
• Last Update Submitted That Met QC Criteria: January 29, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Atherosclerosis; Peripheral artery disease; Atherectomy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: TP0782