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
1 other identifier
interventional
128
2 countries
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2010
Typical duration for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 4, 2010
CompletedFirst Posted
Study publicly available on registry
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedJanuary 31, 2014
January 1, 2014
2.7 years
August 4, 2010
January 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Assessment of Major Adverse Events
From 1 month to 6 months post procedure
Procedural success
Day 1
Clinical success
30 days to 6 months
Target vessel Revascularization
Treatment through 6 months
Study Arms (1)
Phoenix Atherectomy System
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AtheroMed, Inclead
Study Sites (16)
Spring Hill Medical Center
Mobile, Alabama, 36608, United States
Arizona Heart Institute
Phoenix, Arizona, 85016, United States
Arkansas Heart Hospital
Little Rock, Arkansas, 72211, United States
Vascular Interventional Center
Pensacola, Florida, 32504, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
WellStar Health System
Austell, Georgia, 30106, United States
Methodist Research Imstitute /Cobb Hospital
Indianapolis, Indiana, 46202, United States
Cardiovascular Institute of the South
Houma, Louisiana, 70360, United States
Cardiovascular Inst The Regional Med Center/Center of Acadia Institute of the South
Lafayette, Louisiana, 70506, United States
St. John Hospital and Medical Center
Detroit, Michigan, 48236, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Hunterdon Cardiovascular Associated
Flemington, New Jersey, 08822, United States
Columbia University Medical Center/New York Presbyterian
New York, New York, 10032, United States
The Carl & Eduth Lindner Center for Research & Education at the Christ Hospital
Kingsport, Tennessee, 37660, United States
Hochrhein-Eggberg-Klinik GmbH
Bad Säckingen, Germany, 79713, Germany
Park-Hospital Leipzig
Leipzig, Germany, 04289, Germany
Related Publications (1)
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.
PMID: 28950783DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas P Davis, MD
St. John Hospital & Medical Center
- PRINCIPAL INVESTIGATOR
James McKinsey, MD
Columbia University Medical Center/New York Presbyterian
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2010
First Posted
March 1, 2012
Study Start
August 1, 2010
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
January 31, 2014
Record last verified: 2014-01