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

NCT01133327 | Completed

• 1 other identifier: ASTI
• Study Type: interventional
• Target: 100
• Locations: 3 countries
• Sites: 11

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Late ipsilateral stroke

  31 through 365 days post procedure

• System Technical Success

  the procedure time

• Device Malfunctions

  from index procedure to 365 days post procedure

• Serious device-related and procedure-device related Events

  from index procedure to 365 days post procedure

• Target Lesion Revascularization

  from end of index procedure to 365 days postprocedure

Study Arms (1)

Adapt Carotid Stent System

EXPERIMENTAL

Intervention with Adapt Carotid Stent System with the FilterWire EZ System

Device: Carotid Artery Stenting

Interventions

Carotid Artery Stenting 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.

Also known as: Adapt Monorail Carotid Stent system 21mm, 32mm, 40mm, FilterWire Embolic Protection System 3.5 mm - 5.5 mm

Adapt Carotid Stent System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• CRO genae: collaborator
• Massachusetts General Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Medidata Solutions: collaborator

Study Sites (11)

A.Z. Sint Blasius

Dendermonde, East-Flanders, 9200, Belgium

Location

Imelda Ziekenhuis

Bonheiden, B-9200, Belgium

Location

CHU Sart Tilman

Liège, B-400, Belgium

Location

Königin Elisabeth Herzberge

Berlin, D-10365, Germany

Location

Klinikum Dortmund

Dortmund, D-44137, Germany

Location

Universitaetsklinikum Heidelberg

Heidelberg, D69120, Germany

Location

Park KH

Leipzig, D-04289, Germany

Location

Klinikum Neuperlach Munich

Munich, D-81737, Germany

Location

Radiologische Universitätklinik

Tübingen, D-72076, Germany

Location

Hospital Juan Canalejo

A Coruña, 15174, Spain

Location

Complejo Hospitalario de Toledo

Toledo, S-45004, Spain

Location

Related 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. doi: 10.1161/01.STR.0000158921.51037.64. Epub 2005 Mar 3.

  PMID: 15746454 BACKGROUND

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

  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.

  PMID: 18412236 BACKGROUND

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

  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.

  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.

  PMID: 18086926 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Carotid Artery Diseases; Carotid Stenosis; Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Marc Bosiers, MD

  PRINCIPAL INVESTIGATOR

• Monika Hanisch, PhD

  Boston Scientific Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: May 28, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2012
• Last Updated: August 6, 2012

Record last verified: 2012-08

Locations

DE (6); ES (2); BE (3)