NCT03985774

The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 31 (actual)
• Sponsor: Silk Road Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: 1. meeting all inclusion and none of the exclusion criteria, 2. 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.

Conditions

• Carotid Stenosis
• Carotid Artery Diseases
• Carotid Atherosclerosis
• Carotid Artery Plaque

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-02-26
• Primary completion: 2021-03-25
• Completion: 2021-03-25
• First posted: 2019-06-14
• Last updated: 2021-04-19

Locations

3 sites across 3 countries: Belgium, Germany, Spain

Regulatory

• FDA-regulated device study