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

Primary Purpose

Carotid Artery Disease, Carotid Stenosis, Stroke

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Carotid Artery Stenting
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Artery Disease focused on measuring Carotid Artery Stenting, High Risk patient, Carotid artery stenosis, stroke, Carotid artery disease, ASTI study, Adapt Carotid Stent system, FilterWire EZ Embolic Protection System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • A.Z. Sint Blasius
  • Imelda Ziekenhuis
  • CHU Sart Tilman
  • Königin Elisabeth Herzberge
  • Klinikum Dortmund
  • Universitaetsklinikum Heidelberg
  • Park KH
  • Klinikum Neuperlach Munich
  • Radiologische Universitätklinik
  • Hospital Juan Canalejo
  • Complejo Hospitalario de Toledo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adapt Carotid Stent System

Arm Description

Intervention with Adapt Carotid Stent System with the FilterWire EZ System

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Late ipsilateral stroke
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.
Device Malfunctions
Define as any failure of the device to meet performance specifications or otherwise perform as intended, as defined by the investigator.
Serious device-related and procedure-device related Events
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.
In-stent Restenosis
Major Adverse Events Rate by subgroups
Major Adverse Events Rate by subgroups symptomatic and asymptomatic status per center

Full Information

First Posted
May 27, 2010
Last Updated
August 3, 2012
Sponsor
Boston Scientific Corporation
Collaborators
CRO genae, Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Medidata Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT01133327
Brief Title
Adapt Monorail Carotid Stent System: A Postmarket Clinical Follow-up Study
Acronym
ASTI
Official Title
Adapt™ Monorail™ Carotid Stent System: A Postmarket Clinical Follow-up Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
Collaborators
CRO genae, Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Medidata Solutions

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adapt Carotid Stent System
Arm Type
Experimental
Arm Description
Intervention with Adapt Carotid Stent System with the FilterWire EZ System
Intervention Type
Device
Intervention Name(s)
Carotid Artery Stenting
Other Intervention Name(s)
Adapt Monorail Carotid Stent system 21mm, 32mm, 40mm, FilterWire Embolic Protection System 3.5 mm - 5.5 mm
Intervention Description
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.
Primary Outcome Measure Information:
Title
30-day rate of major adverse events
Description
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
Time Frame
30-day postprocedure
Secondary Outcome Measure Information:
Title
Late ipsilateral stroke
Time Frame
31 through 365 days post procedure
Title
System Technical Success
Description
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.
Time Frame
the procedure time
Title
Device Malfunctions
Description
Define as any failure of the device to meet performance specifications or otherwise perform as intended, as defined by the investigator.
Time Frame
from index procedure to 365 days post procedure
Title
Serious device-related and procedure-device related Events
Time Frame
from index procedure to 365 days post procedure
Title
Target Lesion Revascularization
Description
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.
Time Frame
from end of index procedure to 365 days postprocedure
Title
In-stent Restenosis
Time Frame
from end of index procedure to 365 days post procedure
Title
Major Adverse Events Rate by subgroups
Description
Major Adverse Events Rate by subgroups symptomatic and asymptomatic status per center
Time Frame
from index procedure to 365 days post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Bosiers, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Monika Hanisch, PhD
Organizational Affiliation
Boston Scientific Corporation
Official's Role
Study Director
Facility Information:
Facility Name
A.Z. Sint Blasius
City
Dendermonde
State/Province
East-Flanders
ZIP/Postal Code
9200
Country
Belgium
Facility Name
Imelda Ziekenhuis
City
Bonheiden
ZIP/Postal Code
B-9200
Country
Belgium
Facility Name
CHU Sart Tilman
City
Liege
ZIP/Postal Code
B-400
Country
Belgium
Facility Name
Königin Elisabeth Herzberge
City
Berlin
ZIP/Postal Code
D-10365
Country
Germany
Facility Name
Klinikum Dortmund
City
Dortmund
ZIP/Postal Code
D-44137
Country
Germany
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
D69120
Country
Germany
Facility Name
Park KH
City
Leipzig
ZIP/Postal Code
D-04289
Country
Germany
Facility Name
Klinikum Neuperlach Munich
City
Munich
ZIP/Postal Code
D-81737
Country
Germany
Facility Name
Radiologische Universitätklinik
City
Tübingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Hospital Juan Canalejo
City
La Coruna
ZIP/Postal Code
15174
Country
Spain
Facility Name
Complejo Hospitalario de Toledo
City
Toledo
ZIP/Postal Code
S-45004
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
15746454
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.
Results Reference
background
Citation
Nadim Al-Murbarak et al. Carotid Artery Stenting. Lippincott Williams & Wilkins, 2004
Results Reference
background
PubMed Identifier
18412236
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.
Results Reference
background
Citation
World Health Report - 2007, from the World Health Organization. Accesses October 31, 2009
Results Reference
background
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.
Results Reference
background
PubMed Identifier
18086926
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. Erratum In: Circulation. 2010 Jul 6;122(1):e10. Kissela, Bret [corrected to Kissela, Brett].
Results Reference
background
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.
Results Reference
background

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

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