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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Cardiology
Title   CHOICE
Description   The primary objective of this study is to collect data about patients' medical experiences and conditions following treatment of carotid artery stenosis (narrowing) using one of Abbott Vascular's carotid artery stent (metal coil) systems and embolic (blood clot) protection systems.
IRB Number   Pro2939
Inclusion/Notes   INCLUSION:
  • Patient or patient’s legally authorized representative provided informed consent.
  • Patient is considered at high risk for carotid endarterectomy (CEA). See Appendix 2 for the definition of a high risk patient.
  • Patient requires percutaneous carotid angioplasty and stenting for carotid artery disease.
  • Patient’s physician intends to use an RX Acculink with the RX Accunet or an Xact with the Emboshield in the carotid artery as per the FDA approved Indications for Use outlined below:
    • Patients with neurological symptoms and ≥ 50% stenosis of the common or internal carotid artery by ultrasound or angiogram.

    • OR
    • Patients without neurological symptoms and ≥ 80% stenosis of the common or internal carotid artery by ultrasound or angiogram.
EXCLUSION:
  • Adolescents under 18 years.
Status   Completed
Location   Texas Health Presbyterian Hospital Dallas
Principal Name    James Byung R. Park MD
Contact Name   Michelle Morgan
Phone   (214) 345-8308

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