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Adapt Monorail Carotid Stent System: A Postmarket Clinical Follow-up Study (ASTI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01133327
Recruitment Status : Completed
First Posted : May 28, 2010
Last Update Posted : August 6, 2012
CRO genae
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Medidata Solutions
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
The purpose of this study is to get outcomes data for the Adapt Monorail Carotid System used in conjunction with the FilterWire Embolic protection system for treatment of patients that suffer from carotid artery stenosis and that cannot have surgery due to high risk factors.

Condition or disease Intervention/treatment Phase
Carotid Artery Disease Carotid Stenosis Stroke Device: Carotid Artery Stenting Not Applicable

Detailed Description:
According to the World Health Organization, 15 million people suffer stroke each year. Of these, 5 million die and another 5 million are permanently disabled. Predominant mechanism responsible for stroke is embolism from proximal rupture of atherosclerotic plaque and thrombus. 25-30% of stroke deaths related to the carotid stenosis. The primary therapy for carotid occlusive disease is the surgical removal of this atherosclerotic plaque from inside the artery. Another treatment option for subjects with significant surgical risk factors has been found: the carotid artery stenting is a non-surgical procedure which unblocks narrowing of the carotid artery lumen by inserting a small metal tube (stent) to keep the plaque against the wall of the artery to improve blood flow.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adapt™ Monorail™ Carotid Stent System: A Postmarket Clinical Follow-up Study
Study Start Date : June 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2012

Arm Intervention/treatment
Experimental: Adapt Carotid Stent System
Intervention with Adapt Carotid Stent System with the FilterWire EZ System
Device: Carotid Artery Stenting

The Adapt Carotid Stent System is intended to deliver a self-expanding Stent to the extra-cranial carotid arteries via a sheathed percutaneous Monorail delivery system. The Adapt Carotid Stent is a closed cell, self-expanding, rolled nitinol (nickel-titanium alloy) sheet. The stent is thin, flexible and expands to appose the vessel wall.

The FilterWire EZ System is a temporary intravascular guide wire filtration system that is placed in the vessel distal to the lesion to be treated. It consists of either a polyurethane filter bag 1.5 cm in length or a Bionate (polycarbonate urethane) filter bag, 1.0 cm in length attached near the distal end of a 0.014" silicone coated stainless steel guide wire by means of a collapsible, self-conforming, Nitinol filter loop wire.

Other Names:
  • Adapt Monorail Carotid Stent system 21mm, 32mm, 40mm
  • FilterWire Embolic Protection System 3.5 mm - 5.5 mm

Primary Outcome Measures :
  1. 30-day rate of major adverse events [ Time Frame: 30-day postprocedure ]
    30-day rate of major adverse events, defined as the cumulative incidence of any peri-procedural (less or equal to 30 days postprocedure) death, stroke, or Myocardial Infarction

Secondary Outcome Measures :
  1. Late ipsilateral stroke [ Time Frame: 31 through 365 days post procedure ]
  2. System Technical Success [ Time Frame: the procedure time ]
    successful placement and retireval of the FilterWire EZ System, and the successful deployment of the Adapt Carotid Stent sytem in the target carotid artery, with a residual stenosis < or equal to 30% as determined by the core lab.

  3. Device Malfunctions [ Time Frame: from index procedure to 365 days post procedure ]
    Define as any failure of the device to meet performance specifications or otherwise perform as intended, as defined by the investigator.

  4. Serious device-related and procedure-device related Events [ Time Frame: from index procedure to 365 days post procedure ]
  5. Target Lesion Revascularization [ Time Frame: from end of index procedure to 365 days postprocedure ]
    any surgical or percutaneous attempt to revascularize the target lesion after the initial or index treatment when the diameter restenosis is either equal to 50% or above with symptoms related to the target lesion or 80% or above without symptoms related to the target lesion.

  6. In-stent Restenosis [ Time Frame: from end of index procedure to 365 days post procedure ]
  7. Major Adverse Events Rate by subgroups [ Time Frame: from index procedure to 365 days post procedure ]

    Major Adverse Events Rate by subgroups

    • symptomatic and asymptomatic status
    • per center

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • High-risk for carotid endarterectomy due to anatomical or co-morbid conditions and either has neurological symptoms and ≥ 50% stenosis, via angiography or is asymptomatic and has ≥ 80% stenosis, via angiography
  • Target lesion located in the common carotid artery (CCA), internal carotid artery (ICA), or carotid bifurcation
  • Arterial segment to be stented has a diameter between 4mm and 9mm
  • Age ≥ 18 years
  • Life expectancy > 12 months from the date of the index procedure

Exclusion Criteria:

  • Contraindication to percutaneous transluminal angioplasty (PTA)
  • Severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system
  • Lesions in the ostium of the common carotid artery
  • Occlusion of the target vessel
  • Evidence of intraluminal thrombus
  • Known sensitivity to nickel-titanium
  • Known allergy to heparin, aspirin or other anticoagulant/ antiplatelet therapies, or is unable or unwilling to tolerate such therapies
  • Uncorrectable bleeding disorders, or will refuse blood transfusions
  • History of prior life-threatening contrast media reaction
  • Previous stent placement in the target vessel
  • Evolving stroke or intracranial hemorrhage
  • Previous intracranial hemorrhage or brain surgery within the past 12 months
  • Clinical condition that makes endovascular therapy impossible or hazardous

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01133327

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A.Z. Sint Blasius
Dendermonde, East-Flanders, Belgium, 9200
Imelda Ziekenhuis
Bonheiden, Belgium, B-9200
CHU Sart Tilman
Liege, Belgium, B-400
Königin Elisabeth Herzberge
Berlin, Germany, D-10365
Klinikum Dortmund
Dortmund, Germany, D-44137
Universitaetsklinikum Heidelberg
Heidelberg, Germany, D69120
Park KH
Leipzig, Germany, D-04289
Klinikum Neuperlach Munich
Munich, Germany, D-81737
Radiologische Universitätklinik
Tübingen, Germany, D-72076
Hospital Juan Canalejo
La Coruna, Spain, 15174
Complejo Hospitalario de Toledo
Toledo, Spain, S-45004
Sponsors and Collaborators
Boston Scientific Corporation
CRO genae
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Medidata Solutions
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Principal Investigator: Marc Bosiers, MD
Study Director: Monika Hanisch, PhD Boston Scientific Corporation

Nadim Al-Murbarak et al. Carotid Artery Stenting. Lippincott Williams & Wilkins, 2004
World Health Report - 2007, from the World Health Organization. Accesses October 31, 2009
Stroke Facts and Statistics from the Center of Disease Control and Prevention,Division for Heart Disease and Stroke Prevention. Available at Page last modified February 12, 2009. Accessed October 23, 2009.
National Institute of Heath / National Institute of Neurological Disorders and Stroke. NIH Stroke Scale. Available at Accessed October 23, 2009.

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Responsible Party: Boston Scientific Corporation Identifier: NCT01133327     History of Changes
Other Study ID Numbers: ASTI
First Posted: May 28, 2010    Key Record Dates
Last Update Posted: August 6, 2012
Last Verified: August 2012

Keywords provided by Boston Scientific Corporation:
Carotid Artery Stenting
High Risk patient
Carotid artery stenosis
Carotid artery disease
ASTI study
Adapt Carotid Stent system
FilterWire EZ Embolic Protection System

Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases