CNV-2017-02 EXCELLENT REGISTRY
Research type
Research Study
Full title
Embotrap eXtraction & Clot EvaLuation & Lesion Evaluation for NeuroThrombectomy
IRAS ID
266410
Contact name
Arnaud Nicolas
Contact email
Sponsor organisation
Cerenovus, part of DePuy Synthes Products, Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 30 days
Research summary
This is a prospective, observational registry that may enroll up to 1000 patients at approximately 50 sites in Europe, the United States and other regions.
The objective of this study is to assess the efficacy of the EmboTrap® Revascularization Device in a real-world setting, as well as to explore correlations between patient comorbidities, clot characteristics, revascularization rates, and clinical outcomes.
These patients with Acute Ischemic Stroke will be treated with the EmboTrap® Revascularization Device and angiographic imaging will be collected per pass for subsequent review by an independent Imaging Core Lab. Clot will be collected from a subset of a minimum target of 500 subjects from sites who have the infrastructure to support clot collection after each pass of the device for follow on analysis by an independent Central Lab.
After the procedure, subjects will be followed for 90 days per the schedule below:
1. Study procedure
2. 24 Hour Follow-up (+/- 8 hrs)
3. 7 Day/Discharge Follow-up
4. 90 Day Follow-up (+/- 14 days)The medical devices used and all treatment related activities (i.e. the tests and procedures) are conducted per standard operating policies at the treating hospital (study site). The conduct of this study does not affect the hospitals standard operating policies and does not impact the patient’s standard of care.
Study-related activities exclusively consists of the structured collection and evaluation of data; this includes the patient angiographic imaging and the collection of blood clots retrieved from the patient during the procedure.Lay summary of study results: The results from this study exhibited high overall rates of successful reperfusion, good clinical outcomes (measured with mRS), low rates of complications, and effective retrieval of a wide range of clot types. These observations are consistent with previously published real-world registries and the current thrombectomy literature.
Overall, the registry contributes valuable real-world evidence supporting the use of CERENOVUS neurothrombectomy devices across a wide range of patient presentations, clot characteristics, and treatment settings.REC name
London - South East Research Ethics Committee
REC reference
19/LO/1393
Date of REC Opinion
4 Nov 2019
REC opinion
Further Information Favourable Opinion