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

Stroke Clinical Trial

— ASTI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01133327
• Other study ID #: ASTI
• Status: Completed
• Phase: N/A
• First received: May 27, 2010
• Last updated: August 3, 2012
• Start date: June 2010
• Est. completion date: June 2012

Study information

• Verified date: August 2012
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeGermany: Ethics CommissionSpain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carotid Artery Disease
• Carotid Artery Diseases
• Carotid Stenosis
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Belgium	Imelda Ziekenhuis	Bonheiden
Belgium	A.Z. Sint Blasius	Dendermonde	East-Flanders
Belgium	CHU Sart Tilman	Liege
Germany	Königin Elisabeth Herzberge	Berlin
Germany	Klinikum Dortmund	Dortmund
Germany	Universitaetsklinikum Heidelberg	Heidelberg
Germany	Park KH	Leipzig
Germany	Klinikum Neuperlach Munich	Munich
Germany	Radiologische Universitätklinik	Tübingen
Spain	Hospital Juan Canalejo	La Coruna
Spain	Complejo Hospitalario de Toledo	Toledo

Sponsors (5)

Lead Sponsor	Collaborator
Boston Scientific Corporation	Beth Israel Deaconess Medical Center, CRO genae, Massachusetts General Hospital, Medidata Solutions

Countries where clinical trial is conducted

Belgium,  Germany,  Spain, 

References & Publications (7)

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. Epub 2005 Mar 3. Review. — View 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. — View Citation

Nadim Al-Murbarak et al. Carotid Artery Stenting. Lippincott Williams & Wilkins, 2004

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.

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. Epub 2007 Dec 17. Erratum in: Circulation. 2010 Jul 6;122(1):e10. Kissela, Bret [corrected to Kissela, Brett]. — View 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.

World Health Report - 2007, from the World Health Organization. Accesses October 31, 2009

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day rate of major adverse events	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	30-day postprocedure	Yes
Secondary	Late ipsilateral stroke		31 through 365 days post procedure	Yes
Secondary	System Technical Success	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.	the procedure time	No
Secondary	Device Malfunctions	Define as any failure of the device to meet performance specifications or otherwise perform as intended, as defined by the investigator.	from index procedure to 365 days post procedure	No
Secondary	Serious device-related and procedure-device related Events		from index procedure to 365 days post procedure	Yes
Secondary	Target Lesion Revascularization	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.	from end of index procedure to 365 days postprocedure	No
Secondary	In-stent Restenosis		from end of index procedure to 365 days post procedure	No
Secondary	Major Adverse Events Rate by subgroups	Major Adverse Events Rate by subgroups; symptomatic and asymptomatic status; per center	from index procedure to 365 days post procedure	Yes