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New treatment option for Acute Ischemic Stroke
Official title The Pivotal Study of RapidPulseTM Aspiration System
ClinicalTrials.gov ID: NCT06029491
What this study is testing
- What it's testing
- The goal of this clinical trials is to demonstrate the safety and effectiveness for the RapidPulseTM Aspiration System in patients experiencing acute ischemic stroke within 8 hours of symptom onset or last seen normal. Subjects will undergo mechanical thrombectomy (a procedure to remove a clot in the brain which is preventing blood flow), with the RapidPulseTM Aspiration System.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age 18 to 80 years
- Clinical diagnosis of acute ischemic stroke with NIH Stroke Scale (NIHSS) score ≥ 6
- Able to be treated within 8 hours of symptom onset or last known normal (LKN)
- Able to be treated within 120 minutes from the time of the qualifying baseline CT/MR image
- Pre-morbid Modified Rankin Scale (mRS) score 0-1
You likely can't join if
- Intracranial Hemorrhage (ICH)
- Alberta Stroke Program Early CT Score (ASPECTS) \<6
- Intracranial Atherosclerotic Disease (ICAD)
- Multiple or tandem occlusions
- Life expectancy less than 6 months
See the full eligibility criteria
- Age 18 to 80 years
- Clinical diagnosis of acute ischemic stroke with NIH Stroke Scale (NIHSS) score ≥ 6
- Able to be treated within 8 hours of symptom onset or last known normal (LKN)
- Able to be treated within 120 minutes from the time of the qualifying baseline CT/MR image
- Pre-morbid Modified Rankin Scale (mRS) score 0-1
- Angiographic confirmation of large vessel occlusion (LVO) in the anterior (intracranial ICA or MCA M1 or M2 segments) or posterior circulation (vertebral or basilar arteries) as confirmed by digital subtraction...
- Candidate to receive treatment with ADAPT technique (Direct Aspiration First-Pass Technique)
- Intracranial Hemorrhage (ICH)
- Alberta Stroke Program Early CT Score (ASPECTS) \<6
- Intracranial Atherosclerotic Disease (ICAD)
- Multiple or tandem occlusions
- Life expectancy less than 6 months
The study team makes the final eligibility decision.
Where it's taking place
- Torrance, California, United States
- New Haven, Connecticut, United States
- Jacksonville, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Park Ridge, Illinois, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- St Louis, Missouri, United States
- Camden, New Jersey, United States
- Buffalo, New York, United States
- New York, New York, United States
- Pittsburgh, Pennsylvania, United States
- Greenville, South Carolina, United States
- Memphis, Tennessee, United States
- Nashville, Tennessee, United States
- Harlingen, Texas, United States
- Bordeaux, France
- Montpellier, France
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Torrance, California, United States; New Haven, Connecticut, United States; Jacksonville, Florida, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.