Emboshield® and Xact® Post Approval Carotid Stent Trial (The EXACT Study)
This study has been completed.
Sponsor:
Abbott Vascular
Information provided by:
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00287508
First received: February 1, 2006
Last updated: October 16, 2008
Last verified: October 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Carotid Artery Disease Carotid Stenosis Stroke Atherosclerosis |
Device: Carotid artery stenting with filter (interventional) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label |
| 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 |
Resource links provided by NLM:
Further study details as provided by Abbott Vascular:
Primary Outcome Measures:
- 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).
| Estimated Enrollment: | 1500 |
| Study Start Date: | November 2005 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Matt Kiely, Manager Medical Information, Abbott Vascular |
| ClinicalTrials.gov Identifier: | NCT00287508 History of Changes |
| Other Study ID Numbers: | AVD-640-0063 |
| Study First Received: | February 1, 2006 |
| Last Updated: | October 16, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Abbott Vascular:
|
Carotid stenting Carotid endarterectomy Carotid artery disease with severe narrowing of the artery Stroke prevention cerebral infarction |
Additional relevant MeSH terms:
|
Atherosclerosis Carotid Artery Diseases Carotid Stenosis Stroke Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Cardiovascular Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013