Endovascular Atherectomy Safety and Effectiveness Study

Peripheral Vascular Disease Clinical Trial

— EASE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541774
• Other study ID #: TP0782
• Status: Completed
• Phase: Phase 3
• First received: August 4, 2010
• Last updated: January 29, 2014
• Start date: August 2010
• Est. completion date: April 2013

Study information

• Verified date: January 2014
• Source: AtheroMed, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Germany	Hochrhein-Eggberg-Klinik GmbH	Bad Sackingen
Germany	Park-Hospital Leipzig	Leipzig
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	WellStar Health System	Austell	Georgia
United States	St. John Hospital and Medical Center	Detroit	Michigan
United States	Hunterdon Cardiovascular Associated	Flemington	New Jersey
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	Methodist Research Imstitute /Cobb Hospital	Indianapolis	Indiana
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	The Carl & Eduth Lindner Center for Research & Education at the Christ Hospital	Kingsport	Tennessee
United States	Cardiovascular Inst The Regional Med Center/Center of Acadia Institute of the South	Lafayette	Louisiana
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	Spring Hill Medical Center	Mobile	Alabama
United States	Columbia University Medical Center/New York Presbyterian	New York	New York
United States	Vascular Interventional Center	Pensacola	Florida
United States	Arizona Heart Institute	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
AtheroMed, Inc

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Freedom from Major Adverse Events		30 days	Yes
Primary	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	No
Secondary	Assessment of Major Adverse Events		From 1 month to 6 months post procedure	Yes
Secondary	Procedural success	Procedural success rate is defined as the proportion of the target lesions in which the final stenosis is <30% after treatment with atherectomy and any other adjunctive therapy.	Day 1	No
Secondary	Clinical success	Clinical success rate is defined as the proportion of subjects that have procedural successes in all target lesions with achievement of at least one Rutherford Clinical Scale at 30 days and 6 months post procedure,	30 days to 6 months	No
Secondary	Target vessel Revascularization	Incidence of clinically-driven target vessel revascularization or target limb revascularization.	Treatment through 6 months	No