Clinical trial NCT01541774: Endovascular Atherectomy Safety and Effectiveness Study
Official title: A Prospective, Multicenter Clinical Evaluation of the Safety and Effectiveness of the Phoenix Atherectomy™ System in Atherectomy of the Peripheral Vasculature
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Vascular Disease
Keywords: Atherectomy
Atherosclerosis
Peripheral artery disease
Lead sponsor: AtheroMed, Inc
Sponsor class: INDUSTRY
First posted: 2012-03-01
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety: Freedom from Major Adverse Events
timeFrame: 30 days
measure: Efficacy: Technical Success
timeFrame: Day 1
Secondary outcomes:
measure: Assessment of Major Adverse Events
timeFrame: From 1 month to 6 months post procedure
measure: Procedural success
timeFrame: Day 1
measure: Clinical success
timeFrame: 30 days to 6 months
measure: Target vessel Revascularization
timeFrame: Treatment through 6 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Spring Hill Medical Center
state: Alabama
city: Phoenix
country: United States
facility: Arizona Heart Institute
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Pensacola
country: United States
facility: Vascular Interventional Center
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Austell
country: United States
facility: WellStar Health System
state: Georgia
city: Indianapolis
country: United States
facility: Methodist Research Imstitute /Cobb Hospital
state: Indiana
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Lafayette
country: United States
facility: Cardiovascular Inst The Regional Med Center/Center of Acadia Institute of the South
state: Louisiana
city: Detroit
country: United States
facility: St. John Hospital and Medical Center
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Flemington
country: United States
facility: Hunterdon Cardiovascular Associated
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center/New York Presbyterian
state: New York
city: Kingsport
country: United States
facility: The Carl & Eduth Lindner Center for Research & Education at the Christ Hospital
state: Tennessee
city: Bad Sackingen
country: Germany
facility: Hochrhein-Eggberg-Klinik GmbH
city: Leipzig
country: Germany
facility: Park-Hospital Leipzig
Study officials:
affiliation: St. John Hospital & Medical Center
name: Thomas P Davis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University Medical Center/New York Presbyterian
name: James McKinsey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.