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EndoTex NexStent, Filter Wire EZ

Phase 3

Transient Ischemic Attack | Unknown | Neurology |Boston Scientific Corporation|Last Updated: Jan 24, 2008

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment488

FDA Designations

No designations recorded

Clinical trial landscape

EndoTex NexStent, Filter Wire EZ · 1 trial · 3 indications

Phase 3 1
NCT00600327Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™Transient Ischemic Attack
COMPLETED488 Analytics
PHASE3COMPLETED
Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™
Transient Ischemic AttackUnlock trial analytics

Study Endpoints

Primary Endpoints

Major clinical events at one-year defined as any death, stroke or myocardial infarction
1 year
30-day event rate defined as any death, stroke or myocardial infarction less than or equal to 30-days post-procedure; plus the 31-day to 12-month event rate defined as any ipsilateral stroke including any death as a result of an ipsilateral stroke.
1 year

Secondary Endpoints

NexStent™ technical success
post surgery
FilterWire EZ™ technical success
post surgery
Overall system technical success
post surgery
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -

Interventions

NameTypeDescription
EndoTex™ NexStent™DEVICEEndoTex™ NexStent™ is a flexible, fine mesh Nitinol stent used to treat patients that are at high risk of adverse events from carotid endarterectomy and require carotid revascularization of a target vessel that has a reference diameter between 4mm and 9mm and stenosis that is less than 30mm in length.
Filter Wire EZ™DEVICEEPI Fliter Wire EZ™ Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * patient is greater than or equal to 18 years of age. * Anticipated patient life expectancy is of at least one year from the date of the index procedure. * Lesion is located in the common carotid artery (CCA) and/or the internal carotid artery (ICA) or the carotid bifurcation. ...

Countries:United StatesArgentinaGermany
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Frequently asked questions about EndoTex NexStent, Filter Wire EZ

What is EndoTex NexStent, Filter Wire EZ used for?

EndoTex NexStent, Filter Wire EZ is used for carotid artery revascularization in patients with transient ischemic attack, thromboembolic stroke, and for stroke prevention. It is an investigational device being studied in a Phase 3 clinical trial.

Who makes EndoTex NexStent, Filter Wire EZ?

EndoTex NexStent, Filter Wire EZ is developed by Boston Scientific Corporation, which trades under the ticker BSX. The company is conducting a Phase 3 clinical trial to evaluate the device for carotid artery revascularization.

What phase is EndoTex NexStent, Filter Wire EZ in?

EndoTex NexStent, Filter Wire EZ is in Phase 3 clinical development. It is an investigational device and has not been approved by the FDA. One Phase 3 trial has been completed.

What clinical trials is EndoTex NexStent, Filter Wire EZ in?

EndoTex NexStent, Filter Wire EZ is studied in clinical trial NCT00600327, titled 'Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™'. This Phase 3 trial enrolled 488 participants and is completed.

Is EndoTex NexStent, Filter Wire EZ the same as Filter Wire EZ?

EndoTex NexStent, Filter Wire EZ is a combination device that includes the Filter Wire EZ. The clinical trial evaluates both the EndoTex NexStent and the Filter Wire EZ together for carotid artery revascularization.