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

NCT ID: NCT01133327

Last Updated: 2012-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-06-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adapt Carotid Stent System

Intervention with Adapt Carotid Stent System with the FilterWire EZ System

Group Type: EXPERIMENTAL

Carotid Artery Stenting

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Adapt Monorail Carotid Stent system 21mm, 32mm, 40mm; FilterWire Embolic Protection System 3.5 mm - 5.5 mm

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CRO genae

UNKNOWN

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Medidata Solutions

INDUSTRY

Sponsor Role: collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Bosiers, MD

Role: PRINCIPAL_INVESTIGATOR

Monika Hanisch, PhD

Role: STUDY_DIRECTOR

Boston Scientific Corporation

Locations

A.Z. Sint Blasius

Dendermonde, East-Flanders, Belgium

Imelda Ziekenhuis

Bonheiden, , Belgium

CHU Sart Tilman

Liège, , Belgium

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, , Germany

Hospital Juan Canalejo

A Coruña, , Spain

Complejo Hospitalario de Toledo

Toledo, , Spain

Countries

Belgium; Germany; Spain

References

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.

Reference Type: BACKGROUND

PMID: 15746454 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 18412236 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 18086926 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

ASTI

Identifier Type: -

Identifier Source: org_study_id