Carotid Artery Disease
Conditions
Keywords
Carotid Artery Stenting (Endovascular)
Brief summary
The primary objective of this study is to assess the outcomes of stenting with distal protection in the treatment of obstructive carotid artery disease. The devices to be utilized are the Cordis PRECISE® Nitinol Stent Systems (5.5F and 6F) and the Cordis ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW).
Detailed description
Carotid Artery Stenting
Interventions
None listed
Sponsors
Cordis US Corp.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* High-surgical risk patients to be treated consistent with IFU labeling * 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.
Exclusion criteria
* Patients not treated per the IFU * Patients who are contraindicated per the IFU * Patients previously enrolled in the study * Patients requiring stenting of in-stent restenosis after CAS * Inability or refusal to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any death, stroke or any MI | up to 30-days post-procedure |
Secondary
| Measure | Time frame |
|---|---|
| Assess the consistency of MAE rates of stenting with distal protection in the treatment of obstructive carotid artery disease among high, medium and low volume centers with physicians who have validated CASES training levels of 1, 2, 2P or 3 | 30 days |
| Assess the real-world cost-effectiveness of carotid artery stenting in subjects enrolled | Every follow-up where a PRO instrument QoL was assessed |
| Estimate MAE (death and ipsilateral stroke) rate in a subset of the planned total enrollment | 1 year |
Countries
United States
Outcome results
None listed