Clinical trial NCT01133327: Adapt Monorail Carotid Stent System: A Postmarket Clinical Follow-up Study
Official title: Adapt™ Monorail™ Carotid Stent System: A Postmarket Clinical Follow-up Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Artery Disease
Carotid Stenosis
Stroke
Keywords: Carotid Artery Stenting
High Risk patient
Carotid artery stenosis
stroke
Carotid artery disease
ASTI study
Adapt Carotid Stent system
FilterWire EZ Embolic Protection System
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: CRO genae
name: Massachusetts General Hospital
name: Beth Israel Deaconess Medical Center
name: Medidata Solutions
First posted: 2010-05-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 30-day rate of major adverse events
timeFrame: 30-day postprocedure
Secondary outcomes:
measure: Late ipsilateral stroke
timeFrame: 31 through 365 days post procedure
measure: System Technical Success
timeFrame: the procedure time
measure: Device Malfunctions
timeFrame: from index procedure to 365 days post procedure
measure: Serious device-related and procedure-device related Events
timeFrame: from index procedure to 365 days post procedure
measure: Target Lesion Revascularization
timeFrame: from end of index procedure to 365 days postprocedure
measure: In-stent Restenosis
timeFrame: from end of index procedure to 365 days post procedure
measure: Major Adverse Events Rate by subgroups
timeFrame: from index procedure to 365 days post procedure
Other outcomes:
Locations:
city: Dendermonde
country: Belgium
facility: A.Z. Sint Blasius
state: East-Flanders
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Liege
country: Belgium
facility: CHU Sart Tilman
city: Berlin
country: Germany
facility: Königin Elisabeth Herzberge
city: Dortmund
country: Germany
facility: Klinikum Dortmund
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Leipzig
country: Germany
facility: Park KH
city: Munich
country: Germany
facility: Klinikum Neuperlach Munich
city: Tübingen
country: Germany
facility: Radiologische Universitätklinik
city: La Coruna
country: Spain
facility: Hospital Juan Canalejo
city: Toledo
country: Spain
facility: Complejo Hospitalario de Toledo
Study officials:
name: Marc Bosiers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Scientific Corporation
name: Monika Hanisch, PhD
role: STUDY_DIRECTOR
References:
citation: Coward LJ, Featherstone RL, Brown MM. Safety and efficacy of endovascular treatment of carotid artery stenosis compared with carotid endarterectomy: a Cochrane systematic review of the randomized evidence. Stroke. 2005 Apr;36(4):905-11. doi: 10.1161/01.STR.0000158921.51037.64. Epub 2005 Mar 3.
citation: Nadim Al-Murbarak et al. Carotid Artery Stenting. Lippincott Williams & Wilkins, 2004
citation: Hopkins LN, Myla S, Grube E, Wehman JC, Levy EI, Bersin RM, Joye JD, Allocco DJ, Kelley L, Baim DS. Carotid artery revascularization in high surgical risk patients with the NexStent and the Filterwire EX/EZ: 1-year results in the CABERNET trial. Catheter Cardiovasc Interv. 2008 Jun 1;71(7):950-60. doi: 10.1002/ccd.21564.
citation: World Health Report - 2007, from the World Health Organization. Accesses October 31, 2009
citation: Stroke Facts and Statistics from the Center of Disease Control and Prevention,Division for Heart Disease and Stroke Prevention. Available at http://www.cdc.gov/Stroke/stroke_facts.htm. Page last modified February 12, 2009. Accessed October 23, 2009.
citation: Rosamond W, Flegal K, Furie K, Go A, Greenlund K, Haase N, Hailpern SM, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell C, Roger V, Sorlie P, Steinberger J, Thom T, Wilson M, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2008 Jan 29;117(4):e25-146. doi: 10.1161/CIRCULATIONAHA.107.187998. Epub 2007 Dec 17. No abstract available.
citation: National Institute of Heath / National Institute of Neurological Disorders and Stroke. NIH Stroke Scale. Available at http://www.ninds.nih.gov/doctors/NIH_Stroke_Scale_Booklet.pdf. Accessed October 23, 2009.