Carotid Stenting Studies

1.  SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy

Prospective observational study to assess the outcomes of stenting with distal protection for the treatment of obstructive carotid artery disease. The utilized devices are the Cordis PRECISE Nitinol Stent Systems and the Cordis ANGIOGUARD XP Emboli Capture Guidewire. Study sponsor is Cordis Corporation. This study is currently recruiting participants.

2.  A Prospective, Non-Randomized, Evaluation of Low-Risk Patients Undergoing Carotid Stenting With Angiomax (Bivalirudin)

Prospective, non-randomized, single-center cohort study treating internal carotid artery stenosis with the Xact Carotid Artery Stent and Emboshield distal protection system in conjunction with bivalirudin as the procedural anticoagulant. Study sponsor is SPSI d.b.a Capital Cardiovascular Associates. This study is currently recruiting participants.

3.  Carotid With Bivalirudin Angioplasty (COBRA)

Single center randomized clinical trial to evaluate the safety and efficacy of carotid artery stenting using the RX ACCULINK Carotid Stent System with RX ACCUNET Embolic Protection System or PercuSurge GuardWire 3-6 Temporary Occlusion and Aspiration System using Angiomax (bivalirudin) versus heparin as the anticoagulant for treatment of occlusive carotid artery disease in low and high risk patient cohorts. Study sponsor is Medstar Research Institute. This study is currently recruiting participants.

4.  Stenting for Symptomatic Intracranial Artery Stenosis Registry in China

Prospective, observational study to explore the safety profile of stenting procedures for symptomatic intracranial artery stenosis in the Chinese population during the peri-operative period. Study sponsor is Beijing Tiantan Hospital. This study is not yet open for participant recruitment.

5.  PROximal Protection VErsus NON-Protection in Carotid Artery Stenting (PROVENON)

Prospective, randomized study comparing the incidence of new ischemic brain injury detected with MRI after carotid artery stenting in patients treated with and without proximal cerebral protection (Gore Floe Reversal System). Study sponsor is Saarland University. This study is currently recruiting participants.

6.  Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER)

Prospective, single cohort study to evaluate the safety and effectiveness of the MICHI Neuroprotection System with Filter in providing cerebral embolic protection during carotid artery stenting with an FDA approved carotid artery stent. Study sponsor is Silk Road Medical. This study is currently recruiting participants.

7.  Effects of Cerebral Protection With Filters vs. Flow Reversal on Cerebral Embolization After Carotid Artery Stenting

Prospective, randomized study to investigate whether balloon-based protection systems are more effective than filters in reducing emboli to the brain during carotid artery stenting, as detected by MRI and transcranial Doppler. It will also evaluate whether there’s a difference between these two device types for prevention of stroke, heart attacks, and death after carotid stenting. Study sponsor is American Heart Assocition. This study is currently recruiting participants.

8.  Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy (CANOPY)

Non-randomized study to assess the safety and effectiveness of the RX Acculink Carotid Stent System under commercial use in patients at standard risk for adverse events from carotid endarterectomy. Study sponsor is Abbott Vascular. This study is currently recruiting participants.

9.  Safety and Performance Evaluation of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting (WISE)

Nonrandomized single group study to evaluate the safety and performance of WIRION EPD in patients undergoing carotid stenting compared to results of previous US IDE carotid stenting with embolic protection studies. Study sponsor is Gardia Medical. This study is currently recruiting participants.

10.  Carotid Endarterectomy Versus Carotid Artery Stenting in Asymptomatic Patients (ACST-2)

Randomized study evaluating immediate risks and long term benefits of carotid stenting versus carotid endarterectomy in patients with asymptomatic carotid stenosis in whom prompt intervention is felt to be needed, but with uncertainty by the patient and doctor about which treatment modality is more appropriate. Study sponsor is University of Oxford. This study is currently recruiting participants.

11.  Neurological Outcome With Carotid Artery Stenting (CAS)

 Prospective observational study evaluating how well patients undergoing carotid angioplasty and/or stenting for treatment of carotid stenosis will perform on a battery of tests to assess brain function before and after the procedure. Study sponsor is Columbia University. This study is currently recruiting participants.