Emboshield® and Xact® Post Approval Carotid Stent Trial (The EXACT Study)

This study has been completed.
Sponsor:
Information provided by:
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00287508
First received: February 1, 2006
Last updated: October 16, 2008
Last verified: October 2008
  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)
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287508

Sponsors and Collaborators
Abbott Vascular
Investigators
Study Chair: Don E Schwarten, MD Abbott Vascular
  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 July 29, 2014