Endovascular Atherectomy Safety and Effectiveness Study
NCT ID: NCT01541774
Last Updated: 2014-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
128 participants
INTERVENTIONAL
2010-08-31
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phoenix Atherectomy System
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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AtheroMed, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas P Davis, MD
Role: PRINCIPAL_INVESTIGATOR
St. John Hospital & Medical Center
James McKinsey, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University Medical Center/New York Presbyterian
Locations
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Spring Hill Medical Center
Mobile, Alabama, United States
Arizona Heart Institute
Phoenix, Arizona, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Vascular Interventional Center
Pensacola, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
WellStar Health System
Austell, Georgia, United States
Methodist Research Imstitute /Cobb Hospital
Indianapolis, Indiana, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Cardiovascular Inst The Regional Med Center/Center of Acadia Institute of the South
Lafayette, Louisiana, United States
St. John Hospital and Medical Center
Detroit, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Hunterdon Cardiovascular Associated
Flemington, New Jersey, United States
Columbia University Medical Center/New York Presbyterian
New York, New York, United States
The Carl & Eduth Lindner Center for Research & Education at the Christ Hospital
Kingsport, Tennessee, United States
Hochrhein-Eggberg-Klinik GmbH
Bad Säckingen, Germany, Germany
Park-Hospital Leipzig
Leipzig, Germany, Germany
Countries
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References
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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.
Other Identifiers
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TP0782
Identifier Type: -
Identifier Source: org_study_id