Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004732
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2000-02-25
Brief Title:
Carotid Revascularization Endarterectomy Versus Stenting Trial
Sponsor:
Rutgers The State University of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Carotid Revascularization Endarterectomy Versus Stenting Trial CREST
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CREST
Brief Summary:
The purpose of the Carotid Revascularization Endarterectomy versus Stenting Trial CREST is to compare the relatively new procedure of stent-assisted carotid angioplasty CAS to the traditional and accepted surgical approach of carotid endarterectomy CEA for the treatment of carotid artery stenosis to prevent recurrent strokes in those patients who have had a TIA transient ischemic attack or a mild stroke within the past 6 months symptomatic and in those patients who have not had any symptoms within the past 6 months asymptomatic
Detailed Description:
The primary aim of the Carotid Revascularization Endarterectomy versus Stenting Trial CREST is to contrast the relative effectiveness of carotid artery stenting CAS versus carotid endarterectomy CEA in preventing stroke myocardial infarction and death Stents are medical devices approved and commonly used for treatment of heart disease The stent that will be used in this trial is the Rapid ExchangeRX ACCULINKTM Carotid Stent System an elastic-like metal scaffold that is expanded inside a carotid artery to hold the vessel open
The RX ACCUNETTM Embolic Protection System an umbrella-like device that expands above the narrowed portion of the carotid artery will be used in conjunction with the RX ACCULINK stent The RX ACCUNET system is designed to capture embolic material that could break off from the narrowed area in the carotid artery while still allowing blood to flow through the vessel during the procedure Embolic material could block blood flow to the arteries beyond the narrowing and be harmful to the brain The RX ACCUNET System is closed and removed after the stent is placed
CEA involves a neck incision and physical removal of the plaque from the inside of the artery CAS involves insertion of a catheter or tube into an artery in the groin and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck The stent is then placed to cover the plaque and hold the artery open Participants will be randomly assigned to undergo either CAS or CEA and all patients will receive best medical management which includes treatment with aspirin treatment of high blood pressure and treatment of other stroke risk factors Participants will be followed for up to ten years
With the simplification of the protocol for long-term follow-up the focus for secondary outcomes is to assess restenosis and viability of the procedure Restenosis rates on an annual basis in both the endarterectomy and stenting arms of the study will be assessed using carotid duplex ultrasound exams performed annually standard of care
In addition to restenosis the viability of the procedures will be assessed by the need or lack of need for repeat revascularization either open surgical or endovascular after the index procedure The question has a new carotid intervention been performed since last follow-up will be asked at every contact with the patient If answered positively additional data will be collected on the appropriate case report formsCRFs
LINKAGE OF CREST COHORT WITH CENTERS FOR MEDICAID AND MEDICARE SERVICESCMS ADMINISTRATIVE DATA
The purpose of linking Medicare-eligible CREST participants with CMS data files is to assess patient outcomes and utilization of health care services This plan to link in- and out-patient episodes of care using national Medicare data establishes a new resource that will enhance current follow-up strategies as well as explore alternative strategies to ascertain patient outcomes for future clinical studies
The RX ACCUNETTM Embolic Protection System an umbrella-like device that expands above the narrowed portion of the carotid artery will be used in conjunction with the RX ACCULINK stent The RX ACCUNET system is designed to capture embolic material that could break off from the narrowed area in the carotid artery while still allowing blood to flow through the vessel during the procedure Embolic material could block blood flow to the arteries beyond the narrowing and be harmful to the brain The RX ACCUNET System is closed and removed after the stent is placed
CEA involves a neck incision and physical removal of the plaque from the inside of the artery CAS involves insertion of a catheter or tube into an artery in the groin and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck The stent is then placed to cover the plaque and hold the artery open Participants will be randomly assigned to undergo either CAS or CEA and all patients will receive best medical management which includes treatment with aspirin treatment of high blood pressure and treatment of other stroke risk factors Participants will be followed for up to ten years
With the simplification of the protocol for long-term follow-up the focus for secondary outcomes is to assess restenosis and viability of the procedure Restenosis rates on an annual basis in both the endarterectomy and stenting arms of the study will be assessed using carotid duplex ultrasound exams performed annually standard of care
In addition to restenosis the viability of the procedures will be assessed by the need or lack of need for repeat revascularization either open surgical or endovascular after the index procedure The question has a new carotid intervention been performed since last follow-up will be asked at every contact with the patient If answered positively additional data will be collected on the appropriate case report formsCRFs
LINKAGE OF CREST COHORT WITH CENTERS FOR MEDICAID AND MEDICARE SERVICESCMS ADMINISTRATIVE DATA
The purpose of linking Medicare-eligible CREST participants with CMS data files is to assess patient outcomes and utilization of health care services This plan to link in- and out-patient episodes of care using national Medicare data establishes a new resource that will enhance current follow-up strategies as well as explore alternative strategies to ascertain patient outcomes for future clinical studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01NS038384 | NIH | None | httpsreporternihgovquickSearchR01NS038384 |