Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study (CASES-PMS)

Cordis Corporation1 site in 1 country1,500 target enrollmentSeptember 2004

ConditionsCarotid Artery Disease

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Carotid Artery Disease
Sponsor: Cordis Corporation
Enrollment: 1500
Locations: 1
Primary Endpoint: The primary endpoint of this study is a 30-day composite of major adverse clinical events (MAE) including any death, myocardial infarction, or stroke.
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to assess the outcomes of stenting with distal protection in the treatment of obstructive carotid artery disease during peri-approval/initial commercialization in relation to the outcomes of the Sapphire Clinical Trial. The devices to be utilized are the Cordis PRECISE Nitinol Stent Systems and the Cordis ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW).

Registry

clinicaltrials.gov

Start Date

September 2004

End Date

November 2006

Last Updated

18 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cordis Corporation

Eligibility Criteria

Inclusion Criteria

•The patient must be \> 18 years of age.
•The patient has a 50% stenosis (as determined by ultrasound or angiogram) of the common or internal carotid artery and is clinically symptomatic; i.e., within the previous 180 days has experienced symptoms in the ipsilateral carotid artery distribution, defined as:
•one or more TIAs, characterized by distinct focal neurologic dysfunction or monocular blindness with clearing of signs and symptoms within 24 hours, or
•one or more completed strokes (as defined by this protocol) with persistence of symptoms or signs for more than 24 hours (the most recent event is used as the qualifying event), except as excluded below, with stenosis \>50%, (as determined by ultrasound or angiogram) of the common or internal carotid artery, OR The patient must have a \>80% diameter stenosis (as determined by ultrasound or angiogram) of the internal or common carotid artery without neurological symptoms.
•To be entered into the study, the patient must have one or more of the following conditions:
•· congestive heart failure (class III/IV) and/or known severe left ventricular dysfunction LVEF \< 30%
•open heart surgery within six weeks
•recent MI (\>24 hours and \<4 weeks)
•unstable angina (CCS class III/IV)
•synchronous severe cardiac and carotid disease requiring open heart surgery and carotid revascularization

Exclusion Criteria

•The patient is experiencing an acute ischemic neurologic stroke or has experienced a stroke within the past 48 hours.
•There is any visual angiographic or ultrasound evidence of intraluminal thrombus thought to increase the risk of plaque fragmentation and distal embolization.
•There is total occlusion of the target carotid artery treatment site.
•The reference segment diameter (distal common carotid and internal carotid artery segment cephalic to the lesion) is less than 4mm or greater than 9mm. See Instructions For Use, for proper stent sizing. The exception to this would be with a lesion having \>95% stenosis where the true diameter of the distal vessel cannot be determined such as the case with a string sign or distal vessel collapse. In this case the judgment of the interventionalist will prevail with the intention not to oversize the stent to the distal vessel by more than 2mm.
•The patient has any intracranial aneurysm (\> 9 mm).

Outcomes

Primary Outcomes

The primary endpoint of this study is a 30-day composite of major adverse clinical events (MAE) including any death, myocardial infarction, or stroke.

Time Frame: 30 day