An interventional study of Carotid Endarterectomy (CEA) and Carotid Artery Stenting (CAS) in Atherosclerosis, Stroke and Carotid Stenosis, sponsored by Rutgers, The State University of New Jersey. Completed at 115 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-17.
Sponsored by Rutgers, The State University of New Jersey · Not applicable, Interventional, and Prevention
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).
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 Exchange(RX) ACCULINK(TM) Carotid Stent System, an elastic-like metal scaffold that is expanded inside a carotid artery to hold the vessel open.
The RX ACCUNET(TM) 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 forms(CRFs).
LINKAGE OF CREST COHORT WITH CENTERS FOR MEDICAID AND MEDICARE SERVICES(CMS) 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.
813 studies on the registry are indexed under Cerebral Infarction; 181 are open to participants now.
This study's enrollment of 2,502 is above the median of 120 across 532 interventional studies indexed under Cerebral Infarction.
Browse Cerebral Infarction studies →Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Carotid endarterectomy is surgery to remove plaque buildup that causes narrowing (stenosis) in the carotid artery.
Procedure: Carotid Endarterectomy (CEA)
Carotid artery stenting (CAS) is a procedure used to open narrowed carotid arteries. During the procedure, a small, expandable wire tube called a stent is permanently inserted into the carotid artery.
Device: Carotid Artery Stenting (CAS)
CEA involves a neck incision and physical removal of the plaque from the inside of the carotid 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. A stent is then placed to cover the plaque and hold the artery open. Participants randomized to this arm of the trial were treated using the RX Acculink Carotid Stent with or without the RX Accunet Embolic Protection Device.
Also known as: Angioplasty of carotid artery and stent placement.
Any Periprocedural Stroke, Myocardial Infarction, or Death During a 30-day Peri-procedural Period, and Postprocedural Ipsilateral Stroke Thereafter, up to 4-years.
The primary aim of CREST is to assess if the efficacy of CAS differs from that of CEA in preventing stroke, myocardial infarction and death during a 30-day peri-procedural period, or ipsilateral stroke over the follow-up period in patients with symptomatic (\>=50%) or asymptomatic (\>=60%) extracranial carotid stenosis. Four-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.
Time frame: 30 days and 4 years
Differential Efficacy of CAS and CEA in Male and Female Participants in the Primary Endpoint (Any Periprocedural Stroke, Myocardial Infarction, or Death or Postprocedural Ipsilateral Stroke).
4-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.
Time frame: 4 years
| Milestone | Carotid-Artery Stenting (CAS) | Carotid Endarterectomy (CEA) |
|---|---|---|
| Started | 1262 | 1240 |
| Completed | 1193 | 1129 |
| Not completed | 69 | 111 |
| Withdrew: Withdrawal by subject | 36 | 64 |
| Withdrew: Lost to follow-up | 33 | 47 |
The primary aim of CREST is to assess if the efficacy of CAS differs from that of CEA in preventing stroke, myocardial infarction and death during a 30-day peri-procedural period, or ipsilateral stroke over the follow-up period in patients with symptomatic (\>=50%) or asymptomatic (\>=60%) extracranial carotid stenosis. Four-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.
| Percentage | Carotid-Artery Stenting | Carotid Endarterectomy |
|---|---|---|
| Any Periprocedural Stroke, Myocardial Infarction, or Death During a 30-day Peri-procedural Period, and Postprocedural Ipsilateral Stroke Thereafter, up to 4-years. | 7.2 ± 0.8 | 6.8 ± 0.8 |
4-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.
| Percentage | Carotid-Artery Stenting | Carotid Endarterectomy |
|---|---|---|
| Men | 6.2 ± 0.9 | 6.8 ± 1.0 |
| Women | 8.9 ± 1.4 | 6.7 ± 1.3 |
Collected over Periprocedural period. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Carotid-Artery Stenting | — | 322/1,262 (25.5%) | 213/1,262 (16.9%) |
| Carotid Endarterectomy | — | 292/1,240 (23.5%) | 212/1,240 (17.1%) |
| Event | Carotid-Artery Stenting | Carotid Endarterectomy |
|---|---|---|
| Neurologic SAENervous system disorders | 98/1262 | 93/1240 |
| Hemodynamic SAEBlood and lymphatic system disorders | 73/1262 | 56/1240 |
| Cardiovascular SAECardiac disorders | 36/1262 | 49/1240 |
| Miscellaneous SAEGeneral disorders | 43/1262 | 47/1240 |
| Hemorrhagic/Vascular SAEVascular disorders | 32/1262 | 40/1240 |
| Infectious Disorder SAEInfections and infestations | 27/1262 | 19/1240 |
| Angiographic/Procedural SAESurgical and medical procedures | 9/1262 | 9/1240 |
| Metabolic/Electrolyte SAEMetabolism and nutrition disorders | 4/1262 | 4/1240 |
| Other SAEGeneral disorders | 1/1262 | 0/1240 |
| Event | Carotid-Artery Stenting | Carotid Endarterectomy |
|---|---|---|
| Miscellaneous Types of AEs (not serious)General disorders | 83/1262 | 86/1240 |
| Neurologic AE (non-endpoint, non-serious)Nervous system disorders | 65/1262 | 72/1240 |
| Hemodynamic AE (not serious)Blood and lymphatic system disorders | 65/1262 | 45/1240 |
| Angiographic/Procedural AE (not serious)Surgical and medical procedures | 24/1262 | 43/1240 |
| Cardiovascular AE (non-endpoint, non-serious)Cardiac disorders | 34/1262 | 36/1240 |
| Hemorrhagic/vascular AE (not serious)Vascular disorders | 21/1262 | 20/1240 |
| Infectious Disorder AE (not serious)Infections and infestations | 13/1262 | 12/1240 |
| Metabolic/Electrolyte AE (not serious)Metabolism and nutrition disorders | 8/1262 | 4/1240 |
| Other AE (not serious)General disorders | 0/1262 | 1/1240 |
| Neurologic AE (endpoint, non-serious)Nervous system disorders | 1/1262 | 0/1240 |
| Age, Continuous(years) | Carotid-Artery Stenting | Carotid Endarterectomy | Total |
|---|---|---|---|
| Mean | 68.9 ± 9.0 | 69.2 ± 8.7 | 69.0 ± 8.9 |
| Sex: Female, Male(Participants) | Carotid-Artery Stenting | Carotid Endarterectomy | Total |
|---|---|---|---|
| Female | 455 | 417 | 872 |
| Male | 807 | 823 | 1630 |
| Race/Ethnicity, Customized(Participants) | Carotid-Artery Stenting | Carotid Endarterectomy | Total |
|---|---|---|---|
| White | 1172 | 1160 | 2332 |
| Non-White | 81 | 71 | 152 |
| Not Specified | 9 | 9 | 18 |
| Symptomatic Status(Participants) | Carotid-Artery Stenting | Carotid Endarterectomy | Total |
|---|---|---|---|
| Asymptomatic | 594 | 587 | 1181 |
| Symptomatic | 668 | 653 | 1321 |
| Baseline Hypertension(Participants) | Carotid-Artery Stenting | Carotid Endarterectomy | Total |
|---|---|---|---|
| Yes | 1080 | 1061 | 2141 |
| No | 179 | 172 | 351 |
| Unknown | 3 | 7 | 10 |
| Diabetes Status(Participants) | Carotid-Artery Stenting | Carotid Endarterectomy | Total |
|---|---|---|---|
| Yes | 384 | 375 | 759 |
| No | 873 | 857 | 1730 |
| Unknown | 5 | 8 | 13 |
| Dyslipidemia(Participants) | Carotid-Artery Stenting | Carotid Endarterectomy | Total |
|---|---|---|---|
| Yes | 1040 | 1053 | 2093 |
| No | 214 | 174 | 388 |
| Unknown | 8 | 13 | 21 |
| Present Smoker(Participant) | Carotid-Artery Stenting | Carotid Endarterectomy | Total |
|---|---|---|---|
| Yes | 329 | 317 | 646 |
| No | 915 | 899 | 1814 |
| Unknown | 18 | 24 | 42 |
4 further baseline measures are reported on the registry.
Showing the first 100 of 115 sites across 2 countries.
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Rutgers, The State University of New Jersey