©2024 Stanford Medicine
CHOICE: Carotid Stenting For High Surgical-Risk Patients
Not Recruiting
Trial ID: NCT00406055
Purpose
The purposes of this study is to 1) Provide additional information that the commercially
available Abbott Vascular Carotid Stent Systems and Embolic Protection Systems can be used
successfully by a wide range of physicians under commercial use conditions. 2) Provide an
ongoing post-market surveillance mechanism for documentation of clinical outcomes and for
possible extension of the Centers for Medicare and Medicaid Services (CMS) coverage to a
broader group of patients.
Official Title
Carotid Stenting For High Surgical-Risk Patients; Evaluating Outcomes Through The Collection Of Clinical Evidence
Stanford Investigator(s)
Ronald L. Dalman MD
Dr. Walter C. Chidester Professor
Eligibility
Inclusion Criteria:
1. Patient or patient's legally authorized representative provided informed consent.
2. Patient is considered at high risk for carotid endarterectomy (CEA).
3. Patient requires percutaneous carotid angioplasty and stenting for carotid artery
disease.
4. Patients physician intends to use an RX Acculink with either the RX Accunet or
Emboshield Nav 6 in the carotid artery OR the patients physician intends to use an
Xact with the Emboshield or Emboshield Nav6 in the carotid artery as per the FDA
approved Indications for Use as outlined.
Exclusion Criteria:
There are no exclusion criteria for this study
Intervention(s):
device: RX ACCULINK , RX ACCUNET , XACT , EMBOSHIELD and EMBOSHIELD Nav6
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Ronald Dalman
6507255227