EmboTrap® Revascularization Device Registry (EXCELLENT)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03685578 |
Recruitment Status :
Recruiting
First Posted : September 26, 2018
Last Update Posted : August 9, 2022
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Condition or disease | Intervention/treatment |
---|---|
Cerebral Stroke | Device: EmboTrap® Revascularization Device |
Study Type : | Observational |
Estimated Enrollment : | 1000 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Embotrap eXtraction & Clot EvaLuation & Lesion Evaluation for NeuroThrombectomy |
Actual Study Start Date : | September 28, 2018 |
Estimated Primary Completion Date : | July 1, 2023 |
Estimated Study Completion Date : | September 30, 2023 |
Group/Cohort | Intervention/treatment |
---|---|
Mechanical Thrombectomy
EmboTrap® Revascularization Device
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Device: EmboTrap® Revascularization Device
EmboTrap® Revascularization Device |
- Successful Revascularization [ Time Frame: 1 day ]Assess cerebral revascularization using the modified Thrombolysis in Cerebral Infarction (mTICI) score at the end of the procedure.
- All-Cause Mortality [ Time Frame: 90 days ]Summary of all mortality regardless of cause at 90 days post-procedure.
- Symptomatic Intracerebral Hemorrhage [ Time Frame: 24 hours ]Rate of intracranial hemorrhage as detected by brain imaging (CT/MR) measured 24 hours after intervention
- Functional Independence [ Time Frame: 90 days ]
Modified Rankin Scale (mRS) of ≤ 2
Modified Rankin Score (Scale from 0-6):
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Age ≥ 18
- The subject or the subject's legally authorized representative has signed and dated an Informed Consent Form
- Subjects experiencing acute ischemic stroke with angiographic confirmation of Large Vessel Occlusion (LVO)
- A clinical decision has been made to use the EmboTrap® Revascularization Device independently and prior to enrollment in the research study.
- EmboTrap® Revascularization Device is the first attempted device/technique for mechanical thrombectomy for the intracranial occlusion in the subject.
Exclusion Criteria:
- Currently participating in an investigational (drug, device, etc) clinical trial that may confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.
- Confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685578
Contact: Jennifer Alojipan | 949-789-3964 | JAlojipa@its.jnj.com |
United States, Florida | |
Lyerly Neurosurgery Baptist Health | Recruiting |
Jacksonville, Florida, United States, 32207 | |
Principal Investigator: Ricardo Hanel | |
United States, Kentucky | |
Norton Neurology Institute | Recruiting |
Elizabethtown, Kentucky, United States, 42701 | |
Principal Investigator: Shervin Dashti | |
United States, Pennsylvania | |
Geisinger | Recruiting |
Danville, Pennsylvania, United States, 17822 | |
Contact: Chelsie Derr cmderr1@geisinger.edu | |
Principal Investigator: Clemens Schirmer, MD, PhD |
Principal Investigator: | Adnan Siddiqui, MD, PhD | University at Buffalo | |
Principal Investigator: | Tommy Andersson, MD, PhD | AZ Groeninge/ Karolinska University Hospital | |
Principal Investigator: | Raul G Nogueira, MD | Grady Health |
Responsible Party: | Neuravi Limited |
ClinicalTrials.gov Identifier: | NCT03685578 |
Other Study ID Numbers: |
CNV_2017_02 |
First Posted: | September 26, 2018 Key Record Dates |
Last Update Posted: | August 9, 2022 |
Last Verified: | August 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Mechanical thrombectomy, EmboTrap |
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |