CERENOVUS Neurothrombectomy Devices Registry (EXCELLENT)
|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 : September 14, 2023
|Condition or disease||Intervention/treatment|
|Cerebral Stroke||Device: EmboTrap® Revascularization Device Device: CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter|
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||Embotrap eXtraction & Clot EvaLuation & Lesion Evaluation for NeuroThrombectomy|
|Actual Study Start Date :||September 28, 2018|
|Estimated Primary Completion Date :||July 1, 2024|
|Estimated Study Completion Date :||October 1, 2024|
EmboTrap® Revascularization Device, CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter
Device: EmboTrap® Revascularization Device
EmboTrap® Revascularization Device
Device: CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter
CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter
- 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
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: Erin O'Carroll- Godinez||+1 949-433-9824||EOCarro3@its.jnj.com|
|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|