Transcarotid Artery Revascularization for Carotid Artery Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand the long-term effects of the ENROUTE Transcarotid Stent System and Neuroprotection System for individuals with blockages in their carotid arteries, which are critical blood vessels in the neck. The focus is on those with symptoms or risk factors related to these blockages, such as noticeable narrowing in the artery. Participants should have already been part of the initial ROADSTER 3 study and completed their required follow-up. This trial suits individuals who have experienced symptoms like dizziness or vision issues due to carotid artery problems and wish to contribute to research on improving future treatments. As a Phase 4 trial, this research explores how the already FDA-approved treatment benefits more patients.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the ENROUTE Transcarotid Stent System and Neuroprotection System are safe for carotid artery revascularization?
Research has shown that Transcarotid Artery Revascularization (TCAR) is generally well-tolerated. In a large study of over 142,000 patients, TCAR significantly lowered the risk of death within 30 days after the procedure. However, the risk of stroke or death shortly after TCAR was higher compared to carotid endarterectomy, another surgical option. Another study showed that the risk of major issues like death, stroke, or heart attack was relatively low, at 0.7% immediately after the procedure and 3.4% within 30 days.
While some patients experienced a stroke within 30 days, these cases were relatively rare, occurring in about 1.68% of patients. Long-term results indicated that the risk of having a stroke on the treated side of the neck was similar to other procedures over a year. Overall, TCAR has been linked to a low rate of serious complications, making it a promising option for those needing treatment for carotid artery issues.12345Why are researchers excited about this trial?
Researchers are excited about carotid artery revascularization for standard-risk patients because it offers a less invasive option compared to traditional surgical methods like carotid endarterectomy. This technique is particularly appealing as it involves placing a stent to widen the narrowed artery, which can lower the risk of stroke in patients with carotid artery disease. Additionally, this method can be performed with a small incision, potentially reducing recovery time and complications associated with open surgery. The ability to treat both symptomatic and asymptomatic patients with a precise, targeted approach makes this treatment stand out in the field of vascular interventions.
What evidence suggests that the ENROUTE Transcarotid Stent System and Neuroprotection System are effective for carotid artery revascularization?
Research has shown that Transcarotid Artery Revascularization (TCAR) effectively treats carotid artery stenosis, a condition where neck arteries narrow. Studies have found that TCAR poses a lower risk of causing a stroke during the procedure compared to traditional methods. It also typically takes less than an hour and has a reduced risk of damaging the nerves controlling facial movement and sensation. Although TCAR may carry a slightly higher risk of stroke or temporary mini-stroke compared to carotid endarterectomy (another surgery for blocked arteries), it remains a good option due to its general safety and efficiency. These findings suggest TCAR reliably prevents strokes by improving blood flow in the neck's arteries.36789
Who Is on the Research Team?
Marc Schermerhorn, MD
Principal Investigator
Beth Israel Deaconess Medical Center
Jeffrey Jim, MD
Principal Investigator
Abbott Northwestern Minneapolis Heart Institute Foundation
Meghan Dermody, MD
Principal Investigator
Lancaster General Hospital
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants underwent carotid revascularization with the ENROUTE Transcarotid Stent System and Neuroprotection System
Follow-up
Participants are monitored for long-term outcomes including ipsilateral stroke and in-stent restenosis
What Are the Treatments Tested in This Trial?
Interventions
- Transcarotid Artery Revascularization
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Symptomatic or asymptomatic patients with a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA), who underwent carotid artery revascularization.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Silk Road Medical
Lead Sponsor
Citations
Outcomes of transcarotid artery revascularization
TCAR is associated with a lower risk of perioperative stroke compared to TFCAS. TCAR is also associated with shorter operative time, lower risk of CNI and less ...
A Systematic Review and Study-Level Meta-Analysis | Stroke
Compared with CEA, TCAR was associated with a higher rate of stroke or transient ischemic attack (OR, 1.26 [95% CI, 1.03–1.54]) but similar ...
Outcomes and insights from a decade of transcarotid artery ...
TCAR is an effective and efficient first-line therapy for treating carotid artery stenosis, regularly performed in less than 1 hour.
Use of TCAR, TFCAS, and CEA in the US From 2015 to 2019
This cohort study examines the pattern of use, outcomes, and patient and disease factors associated with transcarotid artery ...
a systematic review and network meta-analysis
We provide a comprehensive comparison of the safety, efficacy, and long-term outcomes associated with carotid endarterectomy (CEA), carotid ...
Comparative Safety and Efficacy of Transcarotid Artery ...
Results: Thirteen studies involving 142,032 patients were included in the analysis. TCAR significantly reduced 30-day mortality (RR 0.45; p< ...
Perioperative and 1‐Year Rates of Stroke or Death
Perioperative stroke or death was greater following TCAR when compared with carotid endarterectomy. At 1 year, there was no statistically ...
Safety and efficacy of transcarotid artery revascularization ...
The perioperative and 30-day major adverse event (death, stroke, myocardial infarction) rates were 0.7% and 3.4%, respectively. •. Take Home ...
Risk of Stroke, Death, and Myocardial Infarction Following ...
Transcarotid artery revascularization was associated with a similar risk of 30-day stroke, death, or myocardial infarction or 1-year ipsilateral stroke in ...
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