Ronald L. Dalman MD
Abbott Vascular Carotid Stent Systems and Embolic Protection Systems to treat Carotid Artery Stenosis in High Surgical-Risk Patients
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The purposes of this study are: 1) To 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)To 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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Procedure: Carotid angioplasty and stenting
Phase:
Phase 4Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1. Patient or patient's legally authorized representative provided informed consent.
2. Patient is considered at high risk for carotid endarterectomy (CEA). See below for the definition of a high risk patient.
3. Patient requires percutaneous carotid angioplasty and stenting for carotid artery disease.
4. 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.
High Risk Patients:
Patients at high risk for CEA have significant co-morbidities and/or anatomic risk factors (i.e., recurrent stenosis and/or previous radical neck dissection), and would be poor candidates for CEA in the opinion of a surgeon. Examples of significant co-morbid conditions and anatomical risk factors include, but are not limited to:
- congestive heart failure (CHF) class III/IV;
- left ventricular ejection fraction (LVEF) <30%;
- unstable angina;
- contralateral carotid occlusion;
- recent myocardial infarction (MI);
- previous CEA with recurrent stenosis;
- recurrent stenosis and/or previous radical neck dissection;
- prior radiation treatment to the neck; and
- other conditions that were used to determine patients at high risk for CEA in the prior CAS trials and studies, such as ARCHER, CABERNET, SAPPHIRE, BEACH, and MAVERIC II.
Key Exclusion Criteria:
There are no exclusion criteria for this study.
Additional Study Details
Official Title:
Carotid Stenting For High Surgical-Risk Patients; Evaluating Outcomes Through The Collection Of Clinical Evidence (CHOICE)Anticipated start date:
10/1/2006Lead Sponsor:
Abbott VascularInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- Composite of death, stroke, and MI
Total Number to be Enrolled:
5000Total Number to be Enrolled at Stanford:
25More Information
Secondary ID(s):
- IRB eProtocol number: 15773
- SPO Number: 44368
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
11/24/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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