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Peripheral Vascular DiseasePhase 3EASENCT01541774

Endovascular Atherectomy Safety and Effectiveness Study

A Phase 3 study testing Phoenix Atherectomy System in people with Peripheral Vascular Disease, run by AtheroMed, Inc at 16 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Vascular Disease
What is being tested?
Phoenix Atherectomy System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
16 sitesin 2 countries
Study dates
Aug 2010to Apr 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

16 sites in 2 countries.

16 sites in 2 countries

United States14 sites

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • WellStar Health System

    Austell, Georgia, 30106

  • St. John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Hunterdon Cardiovascular Associated

    Flemington, New Jersey, 08822

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360

  • Methodist Research Imstitute /Cobb Hospital

    Indianapolis, Indiana, 46202

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • The Carl & Eduth Lindner Center for Research & Education at the Christ Hospital

    Kingsport, Tennessee, 37660

  • Cardiovascular Inst The Regional Med Center/Center of Acadia Institute of the South

    Lafayette, Louisiana, 70506

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • Spring Hill Medical Center

    Mobile, Alabama, 36608

  • Columbia University Medical Center/New York Presbyterian

    New York, New York, 10032

  • Vascular Interventional Center

    Pensacola, Florida, 32504

  • Arizona Heart Institute

    Phoenix, Arizona, 85016

Other trials in United States

Germany2 sites

  • Hochrhein-Eggberg-Klinik GmbH

    Bad Säckingen, Germany, 79713

  • Park-Hospital Leipzig

    Leipzig, Germany, 04289

Other trials in Germany

About this study

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

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.

Being tested
Phoenix Atherectomy System
Keywords
Atherectomy, Atherosclerosis, Peripheral artery disease
Medical subject headings
Peripheral Vascular Diseases, Atherosclerosis, Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Phoenix Atherectomy SystemDevice

    Also called Atherectomy, Percutaneous Transluminal Atherectomy, Transluminal Atherectomy, Percutaneous Atherectomy

    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.

Study groups in NCT01541774
Study groupRoleWhat they receive
Phoenix Atherectomy SystemExperimentalNot described
Receives: Device: Phoenix Atherectomy System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety: Freedom from Major Adverse Events

    Measured: 30 days

  2. Efficacy: Technical Success

    The achievement of acute debulking to achieve a post-Phoenix (prior to any adjunctive therapy) residual diameter stenosis of ≤50%.

    Measured: Day 1

Secondary outcomes (4)

  1. Assessment of Major Adverse Events

    Measured: From 1 month to 6 months post procedure

  2. 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.

    Measured: Day 1

  3. 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,

    Measured: 30 days to 6 months

  4. Target vessel Revascularization

    Incidence of clinically-driven target vessel revascularization or target limb revascularization.

    Measured: Treatment through 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2012 (estimated)
  2. Study startAug 2010
  3. Primary completionApr 2013
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01541774
Sponsor's protocol ID
TP0782
Acronym
EASE
Status last verified
Jan 2014
First submitted
4 Aug 2010
Last updated
31 Jan 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28950783

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Phoenix Atherectomy System in people with Peripheral Vascular Disease, run by AtheroMed, Inc at 16 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety: Freedom from Major Adverse Events (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01541774, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2014.

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