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

• ClinicalTrials.gov Identifier: NCT01133327
• Recruitment Status: Completed
• First Posted: May 28, 2010
• Last Update Posted: August 6, 2012
• Sponsor: Boston Scientific Corporation
• Collaborators: CRO genae; Massachusetts General Hospital; Beth Israel Deaconess Medical Center; Medidata Solutions
• Information provided by (Responsible Party): Boston Scientific Corporation

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Carotid Artery Disease; Carotid Stenosis; Stroke	Device: Carotid Artery Stenting	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Adapt™ Monorail™ Carotid Stent System: A Postmarket Clinical Follow-up Study
• Study Start Date: June 2010
• Actual Primary Completion Date: June 2011
• Actual Study Completion Date: June 2012

Arms and Interventions

Arm

Intervention/treatment

Experimental: Adapt Carotid Stent System; Intervention with Adapt Carotid Stent System with the FilterWire EZ System

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Belgium

A.Z. Sint Blasius

Dendermonde, East-Flanders, Belgium, 9200

Imelda Ziekenhuis

Bonheiden, Belgium, B-9200

CHU Sart Tilman

Liege, Belgium, B-400

Germany

Königin Elisabeth Herzberge

Berlin, Germany, D-10365

Klinikum Dortmund

Dortmund, Germany, D-44137

Universitaetsklinikum Heidelberg

Heidelberg, Germany, D69120

Park KH

Leipzig, Germany, D-04289

Klinikum Neuperlach Munich

Munich, Germany, D-81737

Radiologische Universitätklinik

Tübingen, Germany, D-72076

Spain

Hospital Juan Canalejo

La Coruna, Spain, 15174

Complejo Hospitalario de Toledo

Toledo, Spain, S-45004

Sponsors and Collaborators

Boston Scientific Corporation

CRO genae

Massachusetts General Hospital

Beth Israel Deaconess Medical Center

Medidata Solutions

Investigators

• Principal Investigator: Marc Bosiers, MD
• Study Director: Monika Hanisch, PhD; Boston Scientific Corporation

More Information

Publications:

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.

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

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.

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

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.

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. Erratum In: Circulation. 2010 Jul 6;122(1):e10. Kissela, Bret [corrected to Kissela, Brett].

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.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT01133327
• Other Study ID Numbers: ASTI
• First Posted: May 28, 2010
• Last Update Posted: August 6, 2012
• Last Verified: August 2012

Keywords provided by Boston Scientific Corporation:

Carotid Artery Stenting; High Risk patient; Carotid artery stenosis; stroke; Carotid artery disease; ASTI study; Adapt Carotid Stent system; FilterWire EZ Embolic Protection System

Additional relevant MeSH terms:

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