Ronald L. Dalman MD
Stenting procedure with distal protection in the treatment of obstructive carotid artery disease in high-surgical risk patients with atherosclerotic disease of the carotid artery(ies)
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The purpose of this registry is to collect further data or information on the safety and effectiveness of the Cordis PRECISE Nitinol Stent System and the Cordis ANGIOGUARD XP/RX Emboli Capture Guidewire (ECGW), as well as other PRECISE stents that are approved for use by the FDA in the future.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Device: 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. High-surgical risk patients (see note below for definition) to be treated consistent with IFU labeling.
(IFU=Instructions for Use)
2. The patient or legally authorized representative has signed a written informed consent and HIPAA authorization, prior to the procedure, using a form that is approved by the Institutional Review Board or Medical Ethics Committee.
Note: definition of high surgical risk
- Congestive heart failure (class Ill/IV) and/or known severe left ventricular dysfunction LVEF < 35%
- Open-heart surgery within six weeks
- Recent MI (>24 hours and <6 weeks)
- Unstable angina (CCS class III/IV)
- Synchronous severe cardiac and carotid disease requiring open heart surgery and carotid revascularization
- Requirement of simultaneous or staged cardiac valve surgery, peripheral vascular surgery, or AAA repair within 60 days
- Severe pulmonary disease
- Contralateral carotid occlusion
- Contralateral laryngeal palsy
- Post radiation treatment to the neck
- Previous CEA recurrent stenosis
- High cervical ICA lesions or CCA lesions below the clavicle
- Severe tandem lesions
- Abnormal stress test.
- Age >= 80
- Knowledge of two or more proximal or major diseased coronary arteries with > 70% stenosis that have not or cannot be revascularized
- Currently on a list for major organ transplantation or is being evaluated for such
- Dialysis-dependent renal failure
- Spinal immobility with an inability to flex the neck beyond neutral or a kyphotic deformity
- Presence of a tracheostomy stoma
- Bilateral Artery Stenosis as determined by angiography in which both carotid arteries require treatment as defined as:
1) symptomatic on both sides with >= 50% stenosis, or
2) asymptomatic on both sides with >= 80% stenosis, or
3) symptomatic with >= 50% stenosis on one side, and asymptomatic with >=80% stenosis on the other side
Key Exclusion Criteria:
1. Patients not treated per the IFU (IFU=Instructions for Use)
2. Patients who are contraindicated per the IFU
3. Inability due to mental impairment or refusal to provide informed consent
4. Pregnancy
Additional Study Details
Official Title:
STENTING AND ANGIOPLASTY WITH PROTECTION IN PATIENTS AT HIGH-RISK FOR ENDARTERECTOMYAnticipated start date:
9/30/2008Lead Sponsor:
Cordis CorporationInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- To estimate 30-day MAE rate of stenting (any death, stroke or any MI) with distal protection in the treatment of obstructive carotid artery disease in high-surgical risk patients with atherosclerotic disease of the carotid artery(ies).
Secondary Outcomes:
- MAE rate
Total Number to be Enrolled:
10000Total Number to be Enrolled at Stanford:
25More Information
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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