Endovascular Atherectomy Safety and Effectiveness Study (EASE)

AtheroMed

Status and phase

Completed

Phase 3

Conditions

Peripheral Vascular Disease

Treatments

Device: Phoenix Atherectomy System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01541774

TP0782

Details and patient eligibility

About

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.

Enrollment

128 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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