744523
Last Update Posted: 2016-02-26
Recruiting has ended
All Genders accepted | 18 Years + |
262 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Proximal Protection With The Mo.Ma Device During Carotid Stenting
The objective of the ARMOUR study is to evaluate the safety and effectiveness of the Mo.Ma proximal flow blockage cerebral protection device for patients at high surgical risk for carotid endarterectomy who undergo carotid artery stenting
Test Device:
Mo.Ma™ Proximal Flow Blockage Cerebral Protection Device. Single size catheter device with a 9 French introducer sheath compatible shaft (outer diameter) and a 6 French compatible working channel (inner diameter), integrating two compliant balloons intended to achieve endovascular clamping of external carotid arteries (ECA) 3-6 mm in diameter and common carotid arteries (CCA) 5-13 mm in diameter.
Primary Objective:
Evaluate the safety and effectiveness of the Mo.Ma device for cerebral protection in the treatment of internal carotid artery (ICA) stenoses, which may or may not involve the bifurcation of the CCA, in subjects considered to be at high surgical risk for complications during carotid endarterectomy (CEA).
Primary Endpoint:
Major adverse cardiac and cerebrovascular events (MACCE) within 30 days of implantation. MACCE are defined as: any myocardial infarction (MI), stroke, or death through day 30 post-procedure.
Eligibility
Relevant conditions:
Carotid Artery Disease
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov