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Completed

NCT Number: NCT01133327

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.

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Key information

Conditions

Carotid Artery Disease Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

A.Z. Sint Blasius, Dendermonde, East-Flanders, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carotid artery stenting

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Collaborators

  • Beth Israel Deaconess Medical Center
  • CRO genae
  • Massachusetts General Hospital
  • Medidata Solutions

Registry information

Official study title

Adapt™ Monorail™ Carotid Stent System: A Postmarket Clinical Follow-up Study

Acronym: ASTI

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
May 28, 2010
Registry last updated
Aug 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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