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

This study has been completed.
Sponsor:
Collaborators:
CRO genae
Massachusetts General Hospital
The CardioVascular Institute & BethIsrael Deaconess Medical Center
Medidata Solutions
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01133327
First received: May 27, 2010
Last updated: August 3, 2012
Last verified: August 2012
  Purpose

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 Intervention
Carotid Artery Disease
Carotid Stenosis
Stroke
Device: Carotid Artery Stenting

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adapt™ Monorail™ Carotid Stent System: A Postmarket Clinical Follow-up Study

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • 30-day rate of major adverse events [ Time Frame: 30-day postprocedure ] [ Designated as safety issue: Yes ]
    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:
  • Late ipsilateral stroke [ Time Frame: 31 through 365 days post procedure ] [ Designated as safety issue: Yes ]
  • System Technical Success [ Time Frame: the procedure time ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Target Lesion Revascularization [ Time Frame: from end of index procedure to 365 days postprocedure ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Major Adverse Events Rate by subgroups [ Time Frame: from index procedure to 365 days post procedure ] [ Designated as safety issue: Yes ]

    Major Adverse Events Rate by subgroups

    • symptomatic and asymptomatic status
    • per center


Enrollment: 100
Study Start Date: June 2010
Study Completion Date: June 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133327

Locations
Belgium
A.Z. Sint Blasius
Dendermonde, East-Flanders, Belgium, 9200
Imelda Ziekenhuis
Bonheiden, Belgium, B-9200
CHU Sart Tilman
Liege, Belgium, B-400
Germany
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
Spain
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
The CardioVascular Institute & BethIsrael Deaconess Medical Center
Medidata Solutions
Investigators
Principal Investigator: Marc Bosiers, MD
Study Director: Monika Hanisch, PhD Boston Scientific Corporation
  More Information

Publications:
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01133327     History of Changes
Other Study ID Numbers: ASTI
Study First Received: May 27, 2010
Last Updated: August 3, 2012
Health Authority: Belgium: Ethics Committee
Germany: Ethics Commission
Spain: Ethics Committee

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

Additional relevant MeSH terms:
Carotid Artery Diseases
Carotid Stenosis
Constriction, Pathologic
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 17, 2014