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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01133327
First Posted: May 28, 2010
Last Update Posted: August 6, 2012
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.
Collaborators:
CRO genae
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Medidata Solutions
Information provided by (Responsible Party):
Boston Scientific Corporation
May 27, 2010
May 28, 2010
August 6, 2012
June 2010
June 2011   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01133327 on ClinicalTrials.gov Archive Site
  • Late ipsilateral stroke [ Time Frame: 31 through 365 days post procedure ]
  • 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.
  • 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.
  • Serious device-related and procedure-device related Events [ Time Frame: from index procedure to 365 days post procedure ]
  • 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.
  • In-stent Restenosis [ Time Frame: from end of index procedure to 365 days post procedure ]
  • 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
Same as current
Not Provided
Not Provided
 
Adapt Monorail Carotid Stent System: A Postmarket Clinical Follow-up Study
Adapt™ Monorail™ Carotid Stent System: A Postmarket Clinical Follow-up Study
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.
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Carotid Artery Disease
  • Carotid Stenosis
  • Stroke
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
Experimental: Adapt Carotid Stent System
Intervention with Adapt Carotid Stent System with the FilterWire EZ System
Intervention: Device: Carotid Artery Stenting

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2012
June 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Germany,   Spain
 
 
NCT01133327
ASTI
No
Not Provided
Not Provided
Boston Scientific Corporation
Boston Scientific Corporation
  • CRO genae
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Medidata Solutions
Principal Investigator: Marc Bosiers, MD
Study Director: Monika Hanisch, PhD Boston Scientific Corporation
Boston Scientific Corporation
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP