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

Not Applicable

Completed

• Conditions: Carotid Artery Disease; Carotid Stenosis; Stroke
• Interventions: Device: Carotid Artery Stenting

• Registration Number: NCT01133327
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2010-05-27
• Study First Submitted QC: 2010-05-27
• Study First Posted: 2010-05-28
• Study Start: 2010-06
• Primary Completion: 2011-06
• Study Completion: 2012-06
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-03
• Last Update Posted: 2012-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adapt Carotid Stent System	Carotid Artery Stenting	Intervention with Adapt Carotid Stent System with the FilterWire EZ System

Primary Outcome Measures

Name	Time	Method
30-day rate of major adverse events	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

Name	Time	Method
Device Malfunctions	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.
Late ipsilateral stroke	31 through 365 days post procedure
System Technical Success	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.
Target Lesion Revascularization	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	from end of index procedure to 365 days post procedure
Major Adverse Events Rate by subgroups	from index procedure to 365 days post procedure	Major Adverse Events Rate by subgroups; * symptomatic and asymptomatic status; * per center
Serious device-related and procedure-device related Events	from index procedure to 365 days post procedure

Trial Locations

Locations (11)

Königin Elisabeth Herzberge; 🇩🇪 Berlin, Germany

A.Z. Sint Blasius; 🇧🇪 Dendermonde, East-Flanders, Belgium

Imelda Ziekenhuis; 🇧🇪 Bonheiden, Belgium

CHU Sart Tilman; 🇧🇪 Liege, Belgium

Klinikum Dortmund; 🇩🇪 Dortmund, Germany

Universitaetsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Park KH; 🇩🇪 Leipzig, Germany

Klinikum Neuperlach Munich; 🇩🇪 Munich, Germany

Radiologische Universitätklinik; 🇩🇪 Tübingen, Germany

Hospital Juan Canalejo; 🇪🇸 La Coruna, Spain

Complejo Hospitalario de Toledo; 🇪🇸 Toledo, Spain