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

AtheroMed, Inc16 sites in 2 countries128 target enrollmentAugust 2010

ConditionsPeripheral Vascular Disease

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Peripheral Vascular Disease
Sponsor: AtheroMed, Inc
Enrollment: 128
Locations: 16
Primary Endpoint: Safety: Freedom from Major Adverse Events
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

April 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AtheroMed, Inc

Responsible Party

Sponsor

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.

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