Reperfusion Systems for Stroke
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment for individuals who have experienced an acute ischemic stroke, where a blood clot blocks blood flow to the brain. The goal is to evaluate the effectiveness of the Route 92 Medical Reperfusion Systems, a medical device, in removing these clots. This treatment may suit those who had a stroke and received initial treatment with this system within 8 hours of symptom onset. Participants must provide consent within 72 hours after their thrombectomy, a procedure to remove the clot. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for a broader patient population.
What is the safety track record for the Route 92 Medical Reperfusion Systems?
Research has shown that the Route 92 Medical Reperfusion Systems are generally safe. In earlier studies, the system successfully treated blockages causing strokes in 89% of cases, meaning it reached the blocked blood vessel as intended in most patients.
Real-world data from a study involving 193 patients also supports these findings, revealing no major safety issues. Another trial found no significant safety differences compared to another treatment.
The treatment is currently under investigation in a Phase 4 trial, indicating prior approval for some use and suggesting a good safety record. However, like any medical treatment, risks may exist. These studies support the system's safety, but consulting a healthcare provider can help clarify what this means for individual health.12345Why are researchers enthusiastic about this study treatment?
Unlike traditional stroke treatments that often rely on clot-busting medications like tPA or surgical procedures such as thrombectomy, the Route 92 Medical Reperfusion Systems offer a novel approach by using aspiration to remove clots. This system is unique because it directly suctions the clot out of the blood vessel, which can potentially be faster and less invasive than current methods. Researchers are excited about this treatment because it could minimize the time it takes to restore blood flow to the brain, which is crucial in reducing stroke damage and improving patient outcomes. Additionally, this method might offer an alternative for patients who are not suitable candidates for other treatments.
What evidence suggests that the Route 92 Medical Reperfusion Systems is effective for stroke?
Research has shown that the Route 92 Medical Reperfusion Systems, used by participants in this trial, effectively treat sudden strokes caused by blocked blood flow to the brain. Studies indicate that doctors successfully reach brain blockages in over 96% of cases using this system. In a recent study, 50.6% of patients who used this system experienced a good recovery after 90 days. The system also effectively clears blockages on the first try. This evidence supports its use in improving recovery for stroke patients.12356
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Aspiration of thrombus using the Route 92 Medical Reperfusion Systems
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Route 92 Medical Reperfusion Systems
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Aspiration of thrombus using the Route 92 Medical Reperfusion Systems
Find a Clinic Near You
Who Is Running the Clinical Trial?
Route 92 Medical, Inc.
Lead Sponsor
Citations
Route 92 Medical Announces Results of SUMMIT MAX ...
Three highest enrolling sites reported 96% delivery of the super-bore HiPoint 88 Reperfusion System to MI occlusions and 84% first pass effect.
A Randomized Trial of the Super Large Bore HiPoint ...
At 90 days, good clinical outcome (mRS score of ≤2) was achieved in 50.6% in the HiPoint group and 53.3% in the Vecta group (absolute difference ...
3.
route92medical.com
route92medical.com/real-world-data-supports-results-of-route-92-medicals-summit-max-clinical-trial/Real World Data Supports Results of ...
Clinicians successfully delivered the HiPoint Reperfusion System to the stroke-causing occlusion in 96.2% of cases. The primary endpoint of ...
SUMMIT MAX: A Randomized Trial of the Super Large ...
At 90 days, good clinical outcome (mRS score of ≤2) was achieved in 50.6% in the HiPoint group and 53.3% in the Vecta group (absolute difference ...
5.
neuronewsinternational.com
neuronewsinternational.com/route-92-new-data-hipoint-reperfusion-system-summit-rise-launch/Route 92 announces new data on HiPoint reperfusion ...
In the study, clinicians successfully delivered the HiPoint reperfusion system to the stroke-causing occlusion in 96.2% of cases. In addition, ...
Single Arm Trial to Evaluate the Safety and Effectiveness of ...
The objective of the study is to evaluate the safety and effectiveness of the Route 92 Medical Monopoint Reperfusion System with the Hi Point 88 and HiPoint 70 ...
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