Proximal Protection With The Mo.Ma Device During Carotid Stenting

Not Applicable

Completed

Conditions: Carotid Artery Disease

Interventions: Device: Mo.Ma cerebral protection device

Registration Number: NCT00744523

Lead Sponsor: Medtronic Endovascular

Brief Summary: 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

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 262

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mo.ma cerebral protection device	Mo.Ma cerebral protection device	Mo.Ma cerebral protection device

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure.	Up to 30 days after the procedure was performed	Number of subjects with one or more Major Adverse Cardiac and Cerebrovascular Events through 30 days after the procedure. MACCE are defined as: any myocardial infarction (MI), stroke, or death through day 30 post-procedure.

Secondary Outcome Measures

Name	Time	Method
Technical Success	The entire duration of the index procedure	Number of subjects with device success and the ability to successfully implant a carotid stent and obtain a residual stenosis \< 30% during the index procedure(as evaluated by the angiographic core laboratory). Note: Three subjects were missing final angiographic results and therefore Technical and Procedural success could not be defined for these three subjects, thereby, decreasing the number of participants analyzed from 225 to 222.
Device Success	The entire duration of the index procedure	Number of subjects in which the MO.MA was able to be positioned, deployed, and retrieved intact during the index procedure.
Procedural Success	The entire duration of the index procedure through hospital discharge	Number of subjects with technical success without the occurrence of any MACCE or unresolved antegrade flow blockage intolerance during the index hospitalization. Note: Three subjects were missing final angiographic results and therefore Technical and Procedural success could not be defined for these three subjects, thereby, decreasing the number of participants analyzed from 225 to 222.
Restenosis at 30 Days	Up to 30 days after the procedure was performed	Number of subjects with re-narrowing of the lesion at 30 days as defined as a \>= 50% stenosis measured by duplex ultrasound scan.
Target Lesion Revascularization at 30 Days	Up to 30 days after the procedure was performed	Number of subjects with any repeat invasive procedure, including angioplasty, stenting, endarterectomy, or thrombolysis, performed to open or increase lumen diameter inside or within 10 mm of the previously treated lesion.
Access Site Adverse Events	Index Procedure through Hospital Discharge	Number of subjects with adverse events at the percutaneous access site as a result of the index procedure, including bruising, hematoma and bleeding requiring treatment by transfusion of blood products, surgical repair, ultrasound compression or thrombin injection.

Trial Locations

Locations (2): University at Buffalo Neurosurgery
🇺🇸
Buffalo, New York, United States
MidWest Cardiology Research Foundation
🇺🇸
Columbus, Ohio, United States