The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Study (DW-MRI OUS)
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|ClinicalTrials.gov Identifier: NCT03985774|
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : January 31, 2020
|Condition or disease||Intervention/treatment|
|Carotid Stenosis Carotid Artery Diseases Carotid Atherosclerosis Carotid Artery Plaque||Procedure: Transcarotid revascularization|
The ENROUTE Transcarotid NPS has received CE Mark and is commercially available in the European Union. The ENROUTE Transcarotid NPS may be used in conjunction with carotid artery stent approved for revascularization in patients with carotid disease in the context of this study.
This is a prospective, single-arm, multi-center clinical trial of the ENROUTE Transcarotid NPS in conjunction with all commercially approved carotid artery stents used for revascularization in patients with carotid disease.
The goal of this study is to evaluate the incidence of post procedure DW-MRI lesions (relative to baseline) and debris captured in the ENROUTE Transcarotid NPS inline filter during a transcarotid stenting procedure.
A patient is considered enrolled after:
- meeting all inclusion and none of the exclusion criteria,
- the transcarotid arterial sheath has entered into the patient's vasculature. Insertion of the venous sheath does not qualify a patient as enrolled.
Patients who are screened but do not meet all study criteria are considered screen failures and may not be enrolled. Patients in whom an arterial sheath is placed but who do not meet all study entry criteria are considered enrolled.
The Investigator is responsible for maintaining any information pertaining to the Ethics Committee review and approval as required by local law.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||50 participants|
|Target Follow-Up Duration:||30 Days|
|Official Title:||The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Study|
|Actual Study Start Date :||February 26, 2015|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||April 30, 2020|
Patients requiring carotid revascularization
Symptomatic patients, male or female, with atherosclerotic extracranial internal carotid stenosis (ICA) with or without involvement of the contiguous common artery (CCA), that require carotid revascularization.
Procedure: Transcarotid revascularization
The ENROUTE Transcarotid Neuroprotection System (NPS) has received CE Mark and is commercially available in the European Union. The ENROUTE Transcarotid NPS may be used in conjunction with carotid artery stent approved for revascularization in patients with carotid disease The ENROUTE Transcarotid Neuroprotection System is intended to provide transcarotid vascular access, introduction of diagnostic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis
- New White Lesions [ Time Frame: 30 days ]Incidence of new white lesions by DW-MRI post procedure.
- Periprocedural SAEs [ Time Frame: 30 days ]All stroke
- Periprocedural SAEs [ Time Frame: 30 days ]All death
- post-procedure filter debris [ Time Frame: 30 days ]filter debris morphology
- DW-MRI Lesions [ Time Frame: 30 days ]Location of DW-MRI lesions
- DW-MRI Lesions [ Time Frame: 30 days ]Volume of DW-MRI lesions
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985774
|Contact: Richard Ruedyemail@example.com|
|Universitair Ziekenhuis Gent||Completed|
|Technischen Universitat Munchen||Recruiting|
|Contact: Markus Zendler|
|Principal Investigator: Hans-Henning Eckstein, MD|
|Complejo Hospitalario de Toledo||Completed|