---
title: Emboshield® and Xact® Post Approval Carotid Stent Trial (The EXACT Study)
nct_id: NCT00287508
overall_status: COMPLETED
phase: PHASE4
sponsor: Abbott Medical Devices
study_type: INTERVENTIONAL
primary_condition: Carotid Artery Disease
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00287508.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00287508"
ct_last_update_post_date: 2008-10-17
last_seen_at: "2026-05-12T06:00:48.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Emboshield® and Xact® Post Approval Carotid Stent Trial (The EXACT Study)

**Official Title:** Emboshield and Xact Post Approval Carotid Stent Trial Using the Emboshield® BareWire™ Rapid Exchange Embolic Protection System and Xact® Rapid Exchange Carotid Stent System

**NCT ID:** [NCT00287508](https://clinicaltrials.gov/study/NCT00287508)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 1500
- **Lead Sponsor:** Abbott Medical Devices
- **Conditions:** Carotid Artery Disease, Carotid Stenosis, Stroke, Atherosclerosis
- **Start Date:** 2005-11
- **Completion Date:** 2008-01
- **CT.gov Last Update:** 2008-10-17

## Brief Summary

To collect clinical outcome and device performance data on the FDA 510(k)-cleared Emboshield® BareWire™ Rapid Exchange Embolic Protection System and FDA-approved Xact® Rapid Exchange Carotid Stent System when used under commercial use conditions by a broad group of physicians entering the study with differing carotid artery stenting experiences.

## Detailed Description

This is a multi-center, observational, single arm, post-approval study enrolling the following study population:

* Subjects with neurological symptoms and \>= 50% stenosis of the common or internal carotid artery by ultrasound or angiogram (visual estimate), or
* Subjects without neurological symptoms and \>= 80% stenosis of the common or internal carotid artery by ultrasound or angiogram (visual estimate)
* The endpoint for the 1500 subjects enrolled will be a 30-day composite of death, stroke and myocardial infarction (MI).
* For the 500 subjects with 12 month follow-up, the endpoint will be a composite of stroke, death and MI at 30 days and ipsilateral stroke at 12 months (31-365 days).

## Eligibility

- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Subjects who agree to participate in this study and have signed the IRB approved informed consent form.
* Subjects who are willing to have the Emboshield and/or the Xact inserted into the their vasculature.

Exclusion Criteria:

* There are no exclusion criteria for this study.
```

## Interventions

- **Carotid artery stenting with filter (interventional)** (DEVICE)

## Primary Outcomes

- **The endpoint for the 1500 subjects enrolled will be a 30-day composite of death, stroke and myocardial infarction (MI).**
- **For the 500 subjects with 12 month follow-up, the endpoint will be a composite of stroke, death and MI at 30 days and ipsilateral stroke at 12 months (31-365 days).**

## Recent Field Changes (last 30 days)

- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00287508.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00287508*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*