Carotid Artery Disease Clinical Trial
Official title:
INVESTIGATION of FLOW ALTERED, SHORT TRANSCERVICAL CAROTID ARTERY STENTING in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE With Filter.
The purpose of this study is to evaluate the safety and effectiveness of the MICHI™ Neuroprotection System with Filter (MICHI™ NPS+f) in providing cerebral embolic protection during carotid artery stenting. It will be used in conjunction with a FDA approved carotid artery stent for the treatment of carotid artery disease.
Cerebral embolization during carotid artery stenting (CAS) can often precipitate severe
adverse neurological effects. Most major clinical studies of CAS have used distal filters
for cerebral protection and have compared the neurologic complication rates with those of
carotid endarterectomy (CEA). Many currently available embolic protection devices, however,
have limited efficacy in capturing microembolic debris that is liberated during stenting,
pre-dilatation and post-dilatation. Distal protection systems are furthermore limited by the
need to cross the lesion prior to deployment. Some studies have shown a relatively high
incidence of cerebral infarction even when distal protection devices are employed.
Cerebral protection with carotid flow reversal is a method that was developed as an
alternative to the use of distal protection devices. While novel in its approach, this
method too has its limitations. Another technique developed employs carotid flow reversal
prior to traversing the stenosis and can be accomplished by directly accessing the carotid
anatomy without the use of the transfemoral approach. Major benefits to this method include
a simpler route to the target lesion and the ability to perform the procedure on patients
with severe carotid tortuosity and difficult aortic arch anatomy.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02124928 -
Morphological and Serological Criteria of Plaque Vulnerability: Risk Assessment for Symptomatic and Asymptomatic Carotid Artery Stenosis
|
N/A | |
Active, not recruiting |
NCT01597453 -
NOR-SYS: The Norwegian Stroke in the Young Study
|
N/A | |
Completed |
NCT00744523 -
Proximal Protection With The Mo.Ma Device During Carotid Stenting
|
N/A | |
Completed |
NCT00231231 -
Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study (CASES-PMS)
|
Phase 3 | |
Completed |
NCT00597974 -
Neurological Outcome With Carotid Artery Stenting
|
N/A | |
Completed |
NCT00587717 -
The Acute Effect of Statins on Inflammatory Markers of Athersclerotic Tissue
|
N/A | |
Completed |
NCT02536378 -
POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE
|
||
Completed |
NCT02126982 -
Salts of Clopidogrel: Investigation to ENsure Clinical Equivalence
|
||
Active, not recruiting |
NCT01445613 -
Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy
|
N/A | |
Terminated |
NCT01414387 -
Effects of Cerebral Protection With Filters vs. Flow Reversal on Cerebral Embolization After Carotid Artery Stenting
|
N/A | |
Completed |
NCT00406055 -
CHOICE: Carotid Stenting For High Surgical-Risk Patients
|
Phase 4 | |
Completed |
NCT00403078 -
SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy
|
||
Terminated |
NCT01968226 -
TRACER RGD-K5 Carotid Plaque Imaging Study
|
Phase 2 | |
Completed |
NCT00402740 -
Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) (PROTECT)
|
N/A | |
Completed |
NCT00287508 -
Emboshield® and Xact® Post Approval Carotid Stent Trial (The EXACT Study)
|
Phase 4 | |
Completed |
NCT00178672 -
A Single Center of Carotid Stenting With Distal Protection for the Treatment of Obstructive Carotid Artery Disease
|
Phase 4 | |
Recruiting |
NCT02850588 -
SVS VQI TransCarotid Revascularization Surveillance Project
|
||
Completed |
NCT02759653 -
Norwegian Carotid Plaque Study
|
||
Withdrawn |
NCT01042912 -
Frequency Analysis of Carotid Artery Disease
|
N/A | |
Completed |
NCT00530504 -
Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
|
N/A |