CERENOVUS Neurothrombectomy Devices 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 |
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Recruitment Status :
Recruiting
First Posted : September 26, 2018
Last Update Posted : April 24, 2024
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Sponsor:
Cerenovus, Part of DePuy Synthes Products, Inc.
Information provided by (Responsible Party):
Cerenovus, Part of DePuy Synthes Products, Inc.
| Tracking Information | ||||||||||
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| First Submitted Date | September 7, 2018 | |||||||||
| First Posted Date | September 26, 2018 | |||||||||
| Last Update Posted Date | April 24, 2024 | |||||||||
| Actual Study Start Date | September 28, 2018 | |||||||||
| Estimated Primary Completion Date | July 1, 2024 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
Successful Revascularization [ Time Frame: 1 day ] Assess cerebral revascularization using the modified Thrombolysis in Cerebral Infarction (mTICI) score at the end of the procedure.
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| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | CERENOVUS Neurothrombectomy Devices Registry | |||||||||
| Official Title | Embotrap eXtraction & Clot EvaLuation & Lesion Evaluation for NeuroThrombectomy | |||||||||
| Brief Summary | A post-market registry evaluating the EmboTrap® Revascularization Device and CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter in acute ischemic stroke patients with confirmed intracranial large vessel occlusion. | |||||||||
| Detailed Description | The objective of this study are to separately assess the effectiveness of the CERENOVUS neurothrombectomy devices (EmboTrap® Revascularization Device, and Large Bore Catheter/EMBOVAC Aspiration Catheter) in a real-world setting, as well as to explore correlations between patient comorbidities, clot characteristics, revascularization rates, and clinical outcomes.. | |||||||||
| Study Type | Observational | |||||||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Retention: Samples Without DNA Description: thrombus / clot
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| Sampling Method | Non-Probability Sample | |||||||||
| Study Population | Acute Ischemic Stroke patients with confirmed intracranial Large Vessel Occlusion. | |||||||||
| Condition | Cerebral Stroke | |||||||||
| Intervention |
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| Study Groups/Cohorts | Mechanical Thrombectomy
EmboTrap® Revascularization Device, CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter
Interventions:
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| Publications * | Siddiqui AH, Waqas M, Brinjikji W, De Meyer SF, Doyle K, Fiehler J, Hacke W, Hanel RA, Jovin TG, Liebeskind DS, Yoo AJ, Zaidat OO, Andersson T, Nogueira RG. Embotrap Extraction & Clot Evaluation & Lesion Evaluation for NeuroThrombectomy (EXCELLENT) Registry design and methods. J Neurointerv Surg. 2022 Aug;14(8):783-787. doi: 10.1136/neurintsurg-2021-017671. Epub 2021 Oct 13. | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Recruiting | |||||||||
| Estimated Enrollment |
2000 | |||||||||
| Original Estimated Enrollment |
1000 | |||||||||
| Estimated Study Completion Date | October 1, 2024 | |||||||||
| Estimated Primary Completion Date | July 1, 2024 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts |
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| Listed Location Countries | Belgium, France, Germany, Israel, Switzerland, United Kingdom, United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT03685578 | |||||||||
| Other Study ID Numbers | CNV_2017_02 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | |||||||||
| Current Responsible Party | Cerenovus, Part of DePuy Synthes Products, Inc. | |||||||||
| Original Responsible Party | Neuravi Limited | |||||||||
| Current Study Sponsor | Cerenovus, Part of DePuy Synthes Products, Inc. | |||||||||
| Original Study Sponsor | Neuravi Limited | |||||||||
| Collaborators | Not Provided | |||||||||
| Investigators |
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| PRS Account | Cerenovus, Part of DePuy Synthes Products, Inc. | |||||||||
| Verification Date | April 2024 | |||||||||