Endovascular Atherectomy Safety and Effectiveness Study (EASE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AtheroMed, Inc
ClinicalTrials.gov Identifier:
NCT01541774
First received: August 4, 2010
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Peripheral Vascular Disease
Device: Phoenix Atherectomy System
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter Clinical Evaluation of the Safety and Effectiveness of the Phoenix Atherectomy™ System in Atherectomy of the Peripheral Vasculature

Resource links provided by NLM:


Further study details as provided by AtheroMed, Inc:

Primary Outcome Measures:
  • Safety: Freedom from Major Adverse Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Efficacy: Technical Success [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The achievement of acute debulking to achieve a post-Phoenix (prior to any adjunctive therapy) residual diameter stenosis of ≤50%.


Secondary Outcome Measures:
  • Assessment of Major Adverse Events [ Time Frame: From 1 month to 6 months post procedure ] [ Designated as safety issue: Yes ]
  • Procedural success [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.

  • Clinical success [ Time Frame: 30 days to 6 months ] [ Designated as safety issue: No ]
    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,

  • Target vessel Revascularization [ Time Frame: Treatment through 6 months ] [ Designated as safety issue: No ]
    Incidence of clinically-driven target vessel revascularization or target limb revascularization.


Enrollment: 128
Study Start Date: August 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phoenix Atherectomy System 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.
Other Names:
  • Atherectomy
  • Percutaneous Transluminal Atherectomy
  • Transluminal Atherectomy
  • Percutaneous Atherectomy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541774

Locations
United States, Alabama
Spring Hill Medical Center
Mobile, Alabama, United States, 36608
United States, Arizona
Arizona Heart Institute
Phoenix, Arizona, United States, 85016
United States, Arkansas
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
United States, Florida
Vascular Interventional Center
Pensacola, Florida, United States, 32504
United States, Georgia
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
WellStar Health System
Austell, Georgia, United States, 30106
United States, Indiana
Methodist Research Imstitute /Cobb Hospital
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
Cardiovascular Inst The Regional Med Center/Center of Acadia Institute of the South
Lafayette, Louisiana, United States, 70506
United States, Michigan
St. John Hospital and Medical Center
Detroit, Michigan, United States, 48236
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, New Jersey
Hunterdon Cardiovascular Associated
Flemington, New Jersey, United States, 08822
United States, New York
Columbia University Medical Center/New York Presbyterian
New York, New York, United States, 10032
United States, Tennessee
The Carl & Eduth Lindner Center for Research & Education at the Christ Hospital
Kingsport, Tennessee, United States, 37660
Germany
Hochrhein-Eggberg-Klinik GmbH
Bad Sackingen, Germany, 79713
Park-Hospital Leipzig
Leipzig, Germany, 04289
Sponsors and Collaborators
AtheroMed, Inc
Investigators
Principal Investigator: Thomas P Davis, MD St. John Hospital and Medical Center
Principal Investigator: James McKinsey, MD Columbia University Medical Center/New York Presbyterian
  More Information

No publications provided

Responsible Party: AtheroMed, Inc
ClinicalTrials.gov Identifier: NCT01541774     History of Changes
Other Study ID Numbers: TP0782
Study First Received: August 4, 2010
Last Updated: January 29, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AtheroMed, Inc:
Atherectomy
Atherosclerosis
Peripheral artery disease

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014