Your session is about to expire
← Back to Search
Thrombectomy Device
Zoom Reperfusion System for Stroke
N/A
Recruiting
Led By William J Mack, MD
Research Sponsored by Imperative Care, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Large vessel occlusion of the intracranial internal carotid artery (ICA), middle cerebral artery (MCA)-M1 or M2 segments, basilar, or vertebral arteries as evidenced by MRA or CTA
Age 18 and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraprocedural
Awards & highlights
Study Summary
This trial is testing a new system to help people with strokes. The system is called Zoom Reperfusion System.
Who is the study for?
This trial is for adults who've had a severe stroke within the last 8 hours and can undergo thrombectomy. They should have significant but not extreme stroke symptoms, no recent strokes or major pre-existing conditions that could affect results, and not be pregnant. The stroke must be in certain brain arteries without chronic blockage or large existing damage.Check my eligibility
What is being tested?
The Zoom Reperfusion System is being tested to see if it's safe and effective for treating acute ischemic strokes when used during a thrombectomy procedure (a surgery to remove blood clots) performed within 8 hours of the patient's last known normal state.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks from thrombectomy procedures using devices like the Zoom Reperfusion System may include bleeding, infection at the puncture site, allergic reaction to contrast dye used in imaging, vessel damage, or worsening of stroke symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a major blockage in one of the main arteries in my brain.
Select...
I am 18 years old or older.
Select...
I had a CT or MRI scan within 2 hours before starting treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days post-procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Efficacy Endpoint
Primary Safety Endpoint
Secondary outcome measures
Embolization in new territory (ENT)
First pass success
Functional Independence
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Zoom Reperfusion SystemExperimental Treatment1 Intervention
The subject will undergo the endovascular thrombectomy procedure under general anesthesia or conscious sedation. The Imperative Care .088" Catheter will be used to gain access to the vasculature and direct aspiration of the clot will be attempted where feasible. The Zoom Reperfusion System must be the initial and primary device used to remove thrombus.
Find a Location
Who is running the clinical trial?
Imperative Care, Inc.Lead Sponsor
1 Previous Clinical Trials
150 Total Patients Enrolled
William J Mack, MDPrincipal InvestigatorUniversity of Southern California
2 Previous Clinical Trials
6 Total Patients Enrolled
Emir DeljkichStudy DirectorImperative Care, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a major blockage in one of the main arteries in my brain.I received clot-dissolving medication quickly, as recommended.I am 18 years old or older.I had a CT or MRI scan within 2 hours before starting treatment.It seems like the blockage in your brain has been there for a long time based on your medical history, previous scans, or doctor's opinion.You have a significant brain swelling that is pushing the middle part of your brain to one side, as shown in a CT or MRI scan.My doctor believes a clot removal procedure can be done within 8 hours since I was last seen well.Your mRS scale score before the event is 0 or 1.I have a brain tumor larger than 3cm or one that causes symptoms.Your blood vessels are too twisted or narrow for the specified medical equipment to be used safely.You have signs of previous damage to your arteries, like a carotid dissection or blockage.You have a score of 6 or higher on the NIH Stroke Scale.You have a stent in your brain that would make it unsafe to use the thrombectomy devices.I have symptoms that suggest I might have had strokes in more than one area of my brain.You have signs of bleeding inside your brain on a CT or MRI scan.My life expectancy was under 6 months before I had a stroke.For strokes in the front part of the brain, the ASPECTS score should be 6 or higher. For strokes in the back part of the brain, the pc-ASPECTS score should be 8 or higher.I am currently pregnant.I do not have a brain condition like dementia that affects my thinking.My cancer has spread to other parts of my body.I am severely allergic to iodine-based contrast dyes.You have a large area of tissue damage in your brain due to a previous stroke.I had a stroke within the last 3 months.I currently have an infection that affects my whole body.I have a bleeding or clotting disorder.I need treatment for a narrowed artery in my neck based on a scan.I have blockages in multiple blood vessels in my brain.
Research Study Groups:
This trial has the following groups:- Group 1: Zoom Reperfusion System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the primary objective of this investigative undertaking?
"According to the research's sponsor, Imperative Care Inc., the main parameter of evaluation over a 7 day period will be neurological/stroke-related mortality. Additionally, secondary outcomes such as vessel reperfusion rate TICI 2c and above, all serious adverse events and more will monitored throughout this trial."
Answered by AI
How many centers are currently participating in this investigation?
"There are 19 different sites participating in this trial. Among them, Baptist Health (Jacksonville), Ochsner Health (New Orleans) and The Ohio State University Medical Center (Columbus)."
Answered by AI
How many participants are being observed in this medical experiment?
"This clinical trial necessitates the enrollment of 262 patients who meet its inclusion criteria. These individuals can join from places like Baptist Health in Jacksonville, Florida and Ochsner Health in New Orleans, Louisiana."
Answered by AI
Are there any opportunities for individuals to register for this trial presently?
"The trial, initially posted on October 1st 2021 is presently recruiting according to clinicaltrials.gov's information. The data has been most recently updated on November 3rd 2022."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
Mount Sinai
Memorial Hermann
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger