ARMOUR
Proximal Protection With The MO.MA Device During Carotid Stenting
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Status:
This study has been completed.
Purpose:
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
Interventions:
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.
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Location(s):
New York & Ohio
Year Started:
2007
Year Finished:
2009
Year Presented:
2009
Design:
Interventional, Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study.
Inclusion Criteria
General Inclusion Criteria: Subject meets one or more of the high surgical risk criteria; candidate for single lesion carotid artery stenting using a femoral arterial approach;
is willing and able to comply with follow-up evaluations at the specified times; 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 1.1. ≥ 80% stenosis for asymptomatic subjects or 1.2. ≥ 50% stenosis for symptomatic subjects; symptomatic is defined as carotid stenosis associated with ipsilateral transient or visual TIA evidenced by amaurosis 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.
Exclusion Criteria
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; has chronic or paroxysmal atrial fibrillation that is not treated by Coumadin; has undergone prior stenting of the ipsilateral carotid artery; life expectancy is less than twelve months; is unable to respond to external questions and stimuli and to exert a pressure with the contralateral hand; suffering from dementia; has documented intolerance to BOTH heparin and Angiomax; an allergy or contraindication to ASA; has a documented allergy to the device materials; has a documented allergy to radiographic contrast that cannot be pre-treated; has a documented allergy or contraindication to BOTH clopidogrel and ticlopidine; has had active bleeding diathesis requiring blood transfusion within one (1) month prior to index procedure; has had an MI within 72 hours prior to carotid stenting; 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); has a major residual neurological deficit (stroke scales: Barthel ≤ 60, NIH ≥ 15 or Rankin > 3) at pre-procedure neurological exam; has had a transient ischemic attack (TIA) or amaurosis fugax within 48 hours prior to index procedure; has had a stroke or retinal artery occlusion within one (1) month prior to index procedure; 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); is currently being treated for cerebral carcinoma or sarcoma; has peripheral vascular disease, which precludes safe femoral artery sheath insertion; 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; 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; presence of ipsilateral intracranial stenosis that requires treatment; presence of any intracranial tumor(s), arteriovenous malformation(s) (AVMs), or aneurysm(s) requiring treatment; 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.
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.
Primary Outcome:
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 Outcome:
Device Success Technical Success. Procedural Success. Restenosis at 30 days. Target Lesion Revascularization at 30 days. Access Site Complications.
Results:
Results of the 262-patient ARMOUR trial support the safety and effectiveness of Mo.Ma Ultra for patients at high surgical risk for carotid endarterectomy undergoing CAS. Mo.Ma Ultra’s full-time protection and control contributed to a low 30-day stroke rate of 2.3 percent and MACCE (Stroke, death and myocardial infarction) rate of 2.7 percent in the primary endpoint 220-patient population set.
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Source of Information:
ClinicalTrials.gov
Presented at VIVA Conference in Las Vegas October, 2009.
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Web Links and Publications:
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This information last updated on: 10/27/2009
Reviewed on: 10/27/2009.
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