CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 322 enrolled
Drug / intervention
Xact Stent with either Emboshield Pro (Gen 5) or Emboshield (Gen 3)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00402740
NCT00402740N/ACompleted
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Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA)

Abbott Medical Devices·interventional·Posted Nov 22, 2006·Updated Jun 20, 2012

In Brief

A clinical study evaluating Xact Stent with either Emboshield Pro (Gen 5) or Emboshield (Gen 3) for Carotid Artery Disease. Completed, enrolled 322 participants across 38 sites.

Detailed Summary

The purpose of this study is to evaluate the long-term safety and efficacy of the Xact™ Rapid Exchange Carotid Stent System used in conjunction with the Emboshield® Pro Rapid Exchange Embolic Protection System (Generation 5) and the Emboshield® BareWire™ Rapid Exchange Embolic Protection System (Generation 3), in the treatment of atherosclerotic carotid artery disease in high-surgical risk subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarotid Artery Disease
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 22, 2006
Enrollment StartNov 1, 2006
Primary CompletionJun 1, 2011
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 19.6 years ago

Interventions

Xact Stent with either Emboshield Pro (Gen 5) or Emboshield (Gen 3)device

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).