Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) (PROTECT) (PROTECT)
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|ClinicalTrials.gov Identifier: NCT00402740|
Recruitment Status : Completed
First Posted : November 22, 2006
Results First Posted : June 20, 2012
Last Update Posted : June 20, 2012
|Condition or disease||Intervention/treatment||Phase|
|Carotid Artery Disease||Device: Xact Stent with either Emboshield Pro (Gen 5) or Emboshield (Gen 3)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||322 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA)|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||October 2011|
- Device: Xact Stent with either Emboshield Pro (Gen 5) or Emboshield (Gen 3)
All subjects will receive the Xact™ Rapid Exchange Carotid Stent System. The first 220 consecutively enrolled subjects will be treated with the investigational filter system, the Emboshield® Pro Rapid Exchange Embolic Protection System (Generation 5). The remaining subjects will be treated with the FDA approved Emboshield® BareWire™ Rapid Exchange Embolic Protection System (Generation 3).Other Names:
- Xact stent
- Emboshield Pro (Gen 5)
- Emboshield (Gen 3)
- Kaplan-Meier Estimate of Freedom From the Composite of Any Death, Stroke and MI During the 30 Day Post Procedural Period (DSMI), Plus Fatal and Non-fatal Ipsilateral Stroke From 31-365 Days and Annually Thereafter for a Total of 3 Years. [ Time Frame: 3 years ]Freedom from DSMI to 30 days or ipsilateral stroke from 31 days to 3 years. KM event free (%) curve.
- Acute Device Success [ Time Frame: Post-procedure ]Defined by the attainment of <50% residual stenosis covering an area no longer than the original lesion treated with the stent.
- Procedural Success [ Time Frame: 30 Days ]Defined as the attainment of less than 50% residual stenosis (per angiographic core lab) of the target lesion and the absence of DSMI at 30 days post-index procedure.
- Composite of Any Transient Ischemic Attack (TIA) and Amaurosis Fugax [ Time Frame: ≤30 days ]Includes only each subject's first occurrence of each event.
- Kapan-Meier Estimate of Freedom From Clinically Driven Target Lesion Revascularization Through Three Years. [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402740
|Study Chair:||Seemant Chaturvedi, MD||Wayne State University Stroke Program|
|Study Chair:||William A Gray, MD||Columbia University|
|Study Chair:||Jon Matsumura, MD||University of Wisconsin, Madison|