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

Sponsor

Boston Scientific Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT01133327

Collaborator

CRO genae (Other), Massachusetts General Hospital (Other), Beth Israel Deaconess Medical Center (Other), Medidata Solutions (Industry)

100

Enrollment

Locations

Arm

Duration (Months)

9.1

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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	N/A

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

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 :

Jun 1, 2010

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 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

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

30-day rate of major adverse events [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

Late ipsilateral stroke [31 through 365 days post procedure]
System Technical Success [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.
Device Malfunctions [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.
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]
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 [from end of index procedure to 365 days post procedure]
Major Adverse Events Rate by subgroups [from index procedure to 365 days post procedure]
Major Adverse Events Rate by subgroups symptomatic and asymptomatic status per center

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	A.Z. Sint Blasius	Dendermonde	East-Flanders	Belgium	9200
2	Imelda Ziekenhuis	Bonheiden		Belgium	B-9200
3	CHU Sart Tilman	Liege		Belgium	B-400
4	Königin Elisabeth Herzberge	Berlin		Germany	D-10365
5	Klinikum Dortmund	Dortmund		Germany	D-44137
6	Universitaetsklinikum Heidelberg	Heidelberg		Germany	D69120
7	Park KH	Leipzig		Germany	D-04289
8	Klinikum Neuperlach Munich	Munich		Germany	D-81737
9	Radiologische Universitätklinik	Tübingen		Germany	D-72076
10	Hospital Juan Canalejo	La Coruna		Spain	15174
11	Complejo Hospitalario de Toledo	Toledo		Spain	S-45004