NCT03133429

Clinical Study to Evaluate the Safety and Effectiveness of MER® Stents in Carotid Revascularisation.

Badanie Kliniczne oceniające bezpieczeństwo i skuteczność Stosowania stentów Szyjnych MER® w Rewaskularyzacji tętnic Szyjnych.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Balton Sp.zo.o. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to confirm, whether the MER® stent can be used, without limitations, for the endovascular carotid stenosis treatment in daily clinical practice. Eligible patients will undergo the procedure of the common or internal carotid artery stenting using MER® with proximal or distal neuroprotection.

Detailed description

MER® stent will be implanted in eligible patients with common and internal carotid stenosis after an informed consent. Potential benefit of the MER® stent implantation will be evaluated based on angiography and duplex Doppler ultrasound examination. Follow ups are scheduled at 30 days, 6 and 12 months after index procedure. Except for clinical follow up patients will undergo carotid vessels ultrasound examination after 6 and 12 months. In case of an emergency visit, caused by the Serious Adverse Event, Patient will undergo: neurological and cardiac evaluation as well as carotid vessels USG examination and extended CT or MRI scans. In general, all procedures in the study will follow the local standard of care. The type of devices used during the angioplasty (including the MER® stents) will not differ from the devices used in the usual clinical practice in the hospital. DAPT and other medical therapy will be consistent with the rules of the Polish and European Society of Cardiology.

Conditions

• Carotid Artery Stenosis

Interventions

Type	Name	Description
DEVICE	MER	carotid artery stenting

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-06-22
• Completion: 2019-06-25
• First posted: 2017-04-28
• Last updated: 2019-11-19

Locations

4 sites across 1 country: Poland