Proximal Protection With The Mo.Ma Device During Carotid Stenting

Study Overview
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Brief Summary
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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
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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.

Official Title
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ARMOUR: Proximal Protection With The Mo.Ma Device During Carotid Stenting

Conditions
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Carotid Artery Disease

Intervention / Treatment
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* Device: Mo.Ma cerebral protection device


Participation Criteria
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Eligibility Criteria
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General inclusion criteria Subject meets one or more of the high surgical risk criteria. Subject is ≥ 18 years old. Subject is a candidate for single lesion carotid artery stenting using a femoral arterial approach. Subject is willing and able to comply with follow-up evaluations at the specified times. Subject (or legal representative) understands the nature of the procedure and provides informed consent, prior to enrollment in the study. If female subject, is not currently pregnant and has stated that she has no intention of becoming pregnant during the study. Angiographic inclusion criteria (as determined ≤ 30 days prior to procedure): Target lesion stenosis (% stenosis = (1-N/D) X 100)1, documented by selective angiography pre-intervention, is ≥ 80% stenosis for asymptomatic subjects or ≥ 50% stenosis for symptomatic subjects. Symptomatic is defined as carotid stenosis associated with ipsilateral transient or visual TIA evidenced byamaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral ischemic stroke within 6 months prior to enrollment. Target lesion is within the internal carotid artery and/or involves the bifurcation of the CCA. External carotid artery diameter where the Mo.Ma device will be positioned is 3-6 mm. Common carotid artery diameter where the Mo.Ma device will be positioned is 5-13 mm. General exclusion criteria Subject has participated in, is participating in, or plans to participate in another clinical study that may affect either the pre-procedure or follow-up results. Subject has chronic or paroxysmal atrial fibrillation that is not treated by Coumadin. Subject has undergone prior stenting of the ipsilateral carotid artery. Subject's life expectancy is less than twelve months. Subject is unable to respond to external questions and stimuli and to exert a pressure with the contralateral hand. Subject is suffering from dementia. Subject has documented intolerance to BOTH heparin and Angiomax. Subject has an allergy or contraindication to acetylsalicylic acid (ASA). Subject has a documented allergy to the device materials. Subject has a documented allergy to radiographic contrast that cannot be pre-treated. Subject has a documented allergy or contraindication to BOTH clopidogrel and ticlopidine. Subject has had active bleeding diathesis requiring blood transfusion within one (1) month prior to index procedure. Subject has had an MI within 72 hours prior to carotid stenting. Subject has had coronary artery bypass graft (CABG) or vascular surgery within 30 days PRIOR TO index procedure (percutaneous coronary intervention is permissible provided cardiac enzymes are normal within 24 hours of index procedure), OR has planned CABG, vascular surgery, percutaneous coronary intervention (PCI), or has other invasive medical procedures planned within 30 days AFTER index procedure.(Unplanned urgent or emergent procedures may be performed at anytime as clinically indicated). Subject has a major residual neurological deficit (stroke scales: Barthel ≤ 60, NIH ≥ 15 or Rankin > 3) at pre-procedure neurological exam. Subject has had a transient ischemic attack (TIA) or amaurosis fugax within 48 hours prior to index procedure. Subject has had a stroke or retinal artery occlusion within one (1) month prior to index procedure. Subject had abnormal pre-intervention blood counts with platelets < 50,000/cubic mm or > 700,000/cubic mm or white blood cell count < 3,000/cubic mm. Subject has severe chronic renal failure (creatinine > 2.5 mg/dl). Subject is currently being treated for cerebral carcinoma or sarcoma. Subject has peripheral vascular disease, which precludes safe femoral artery sheath insertion. Subject is unable or unwilling to undergo insertion of a temporary pacemaker. Angiographic exclusion criteria (as determined ≤ 30 days prior to procedure): The target carotid artery is completely occluded. The common carotid artery ostium has stenosis that requires treatment. Multiple carotid stenoses exist in the internal carotid artery (ICA) that cannot be covered by one stent. The presence of ipsilateral intracranial stenosis that requires treatment. The presence of any intracranial tumor(s), arteriovenous malformation(s) (AVMs), or aneurysm(s) requiring treatment. The inability to position a stiff .035 guidewire in the external carotid artery (ECA). Contralateral occlusion of internal carotid artery and vertebral arteries. Aortic arch anatomical anomalies that preclude the safe placement of the device.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mo.ma cerebral protection device<br>Mo.Ma cerebral protection device | Device: Mo.Ma cerebral protection device<br>* Proximal embolic protection based on the principle endovascular clamping consisting of a catheter with two compliant balloons. 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. Cerebral protection is established prior to the initial wire passage through the stenosis and maintained during the entire procedure. 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.<br>* Other names: Mo.Ma;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure. | 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. | Up to 30 days after the procedure was performed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Success | Number of subjects in which the MO.MA was able to be positioned, deployed, and retrieved intact during the index procedure. | The entire duration of the index procedure | 
| Technical Success | 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. | The entire duration of the index procedure | 
| Procedural Success | 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. | The entire duration of the index procedure through hospital discharge | 
| Restenosis at 30 Days | Number of subjects with re-narrowing of the lesion at 30 days as defined as a >= 50% stenosis measured by duplex ultrasound scan. | Up to 30 days after the procedure was performed | 
| Target Lesion Revascularization at 30 Days | 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. | Up to 30 days after the procedure was performed | 
| Access Site Adverse Events | 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. | Index Procedure through Hospital Discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carotid artery stenting, stroke, cerebral protection, high surgical risk