Proximal Protection With The MO.MA Device During Carotid Stenting "ARMOUR"

Completed

Phase N/A Results

Trial Description

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 (Mo.Ma). Single size catheter device with a 9F introducer sheath compatible shaft (outer diameter) and a 6F 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.

Conditions

Interventions

  • Mo.Ma™ Proximal Flow Blockage Cerebral Protection Device (Mo.Ma). Other
    Intervention Desc: Single size catheter device with a 9F introducer sheath compatible shaft (outer diameter) and a 6F 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.
  • Carotid Artery Stenting with cerebral protection with the MO.MA device Device
    Intervention Desc: MO.MA: a proximal embolic protection based on the principle endovascular clamping consisting of a catheter with two compliant balloons at its distal portion which can be independently inflated and deflated. A central lumen allows advancement and usage of the interventional devices (PTA balloons and carotid stents). The MO.MA is designed to achieve cerebral protection by proximal blood flow blockage at the carotid bifurcation: antegrade and retrograde flow blockage are achieved by proximal balloon occlusion of the CCA and distal balloon occlusion of the ECA, respectively. Cerebral protection is thus established prior to the initial wire passage through the stenosis and maintained during the entire procedure. The MO.MA provides withdrawal of embolic particles by allowing manual syringe aspiration of any micro-emboli at the end of the procedure before restoring blood flow through the stented vessel.
    ARM 1: Kind: Experimental
    Label: 1
    Description: Single arm study in which all patients fulfilling the eligibility criteria will be screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Patient Involvement

Single arm study in which all patients fulfilling the eligibility criteria will be screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device and followed for 3 months for outcome data.

Outcomes

Type Measure Time Frame Safety Issue
Primary 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.
Secondary Device Success Technical Success. Procedural Success. Restenosis at 30 days. Target Lesion Revascularization at 30 days. Access Site Complications.
Primary Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure. Up to 30 days after the procedure was performed Yes
Secondary Device Success The entire duration of the index procedure Yes
Secondary Technical Success The entire duration of the index procedure Yes
Secondary Procedural Success The entire duration of the index procedure through hospital discharge Yes
Secondary Restenosis at 30 Days Up to 30 days after the procedure was performed No
Secondary Target Lesion Revascularization at 30 Days Up to 30 days after the procedure was performed No
Secondary Access Site Adverse Events Index Procedure through Hospital Discharge Yes

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