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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).
Carotid Artery Stenting
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| Measure | Description | Time Frame |
|---|---|---|
| Any death, stroke or any MI | up to 30-days post-procedure |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Study population will consist of high-surgical risk patients with atherosclerotic disease of the carotid artery(ies) from up to 350 clinical sites in the US and Canada.
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| Name | Affiliation | Role |
|---|---|---|
| Rajesh Dave, MD | Harrisburg Hospital, 2808 Old Post Rd., Harrisburg, PA 17110 | Principal Investigator |
| Robert Hibbard, MD | Bryan LGH Heart Institute, 1500 South 48th St, Suite 400, Lincoln, NE 68506 | Principal Investigator |
| Douglas Massop, MD | Iowa Clinic-Heart and Vascular Care, 5950 University Ave, West Des Moines, IA 50266 | Principal Investigator |
| Christopher Metzger, MD | The Heart Center, PC, 2050 Meadowview Parkway, Kingsport, TN 37660 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christiana Care Health Services | Newark | Delaware | 19713 | United States | ||
| Iowa Clinic, Heart & Vascular Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18924164 | Result | Massop D, Dave R, Metzger C, Bachinsky W, Solis M, Shah R, Schultz G, Schreiber T, Ashchi M, Hibbard R; SAPPHIRE Worldwide Investigators. Stenting and angioplasty with protection in patients at high-risk for endarterectomy: SAPPHIRE Worldwide Registry first 2,001 patients. Catheter Cardiovasc Interv. 2009 Feb 1;73(2):129-36. doi: 10.1002/ccd.21844. | |
| 41608717 |
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| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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 |
| West Des Moines |
| Iowa |
| 50266 |
| United States |
| Bryan LGH Heart Institute | Lincoln | Nebraska | 68506 | United States |
| Harrisburg Hospital | Harrisburg | Pennsylvania | 17110 | United States |
| The Heart Center, PC | Kingsport | Tennessee | 37660 | United States |
| Qureshi O, Mena-Hurtado C, Romain G, Cleman J, Callegari S, Smolderen KG. Applying a Random Forest Approach in Predicting Health Status in Patients with Carotid Artery Stenosis 30 Days Post Stenting. Stroke Vasc Interv Neurol. 2025 Sep 26;5(6):e001938. doi: 10.1161/SVIN.125.001938. eCollection 2025 Nov. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |