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

This study has been completed.
Sponsor:
Information provided by:
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00744523
First received: August 29, 2008
Last updated: January 25, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention
Carotid Artery Disease
Stroke Prevention
Device: Carotid Artery Stenting with cerebral protection with the MO.MA device

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: ARMOUR: Proximal Protection With The MO.MA Device During Carotid Stenting

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure. [ Time Frame: Up to 30 days after the procedure was performed ] [ Designated as safety issue: Yes ]
    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:
  • Device Success [ Time Frame: The entire duration of the index procedure ] [ Designated as safety issue: Yes ]
    Number of subjects in which the MO.MA was able to be positioned, deployed, and retrieved intact during the index procedure.

  • Technical Success [ Time Frame: The entire duration of the index procedure ] [ Designated as safety issue: Yes ]

    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 participans analyzed from 225 to 222.


  • Procedural Success [ Time Frame: The entire duration of the index procedure through hospital discharge ] [ Designated as safety issue: Yes ]

    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 participans analyzed from 225 to 222.


  • Restenosis at 30 Days [ Time Frame: Up to 30 days after the procedure was performed ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 30 days after the procedure was performed ] [ Designated as safety issue: No ]
    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 [ Time Frame: Index Procedure through Hospital Discharge ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 262
Study Start Date: September 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Device: Carotid Artery Stenting with cerebral protection with the MO.MA device
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

General inclusion criteria

  1. Subject meets one or more of the high surgical risk criteria .
  2. Subject is ≥ 18 years old.
  3. Subject is a candidate for single lesion carotid artery stenting using a femoral arterial approach.
  4. Subject is willing and able to comply with follow-up evaluations at the specified times.
  5. Subject (or legal representative) understands the nature of the procedure and provides informed consent, prior to enrollment in the study.
  6. 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):

  1. 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.

  2. Target lesion is within the internal carotid artery and/or involves the bifurcation of the CCA.
  3. External carotid artery diameter where the Mo.Ma device will be positioned is 3-6 mm.
  4. Common carotid artery diameter where the Mo.Ma device will be positioned is 5-13 mm.

General exclusion criteria

  1. 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.
  2. Subject has chronic or paroxysmal atrial fibrillation that is not treated by Coumadin.
  3. Subject has undergone prior stenting of the ipsilateral carotid artery.
  4. Subject's life expectancy is less than twelve months.
  5. Subject is unable to respond to external questions and stimuli and to exert a pressure with the contralateral hand.
  6. Subject is suffering from dementia.
  7. Subject has documented intolerance to BOTH heparin and Angiomax.
  8. Subject has an allergy or contraindication to ASA.
  9. Subject has a documented allergy to the device materials.
  10. Subject has a documented allergy to radiographic contrast that cannot be pre-treated.
  11. Subject has a documented allergy or contraindication to BOTH clopidogrel and ticlopidine.
  12. Subject has had active bleeding diathesis requiring blood transfusion within one (1) month prior to index procedure.
  13. Subject has had an MI within 72 hours prior to carotid stenting.
  14. 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).
  15. Subject has a major residual neurological deficit (stroke scales: Barthel ≤ 60, NIH ≥ 15 or Rankin > 3) at pre-procedure neurological exam.
  16. Subject has had a transient ischemic attack (TIA) or amaurosis fugax within 48 hours prior to index procedure.
  17. Subject has had a stroke or retinal artery occlusion within one (1) month prior to index procedure.
  18. 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.
  19. Subject has severe chronic renal failure (creatinine > 2.5 mg/dl).
  20. Subject is currently being treated for cerebral carcinoma or sarcoma.
  21. Subject has peripheral vascular disease, which precludes safe femoral artery sheath insertion.
  22. Subject is unable or unwilling to undergo insertion of a temporary pacemaker.

Angiographic exclusion criteria (as determined ≤ 30 days prior to procedure):

  1. The target carotid artery is completely occluded.
  2. The common carotid artery ostium has stenosis that requires treatment.
  3. Multiple carotid stenoses exist in the internal carotid artery (ICA) that cannot be covered by one stent.
  4. The presence of ipsilateral intracranial stenosis that requires treatment.
  5. The presence of any intracranial tumor(s), arteriovenous malformation(s) (AVMs), or aneurysm(s) requiring treatment.
  6. The inability to position a stiff .035" guidewire in the external carotid artery (ECA).
  7. Contralateral occlusion of internal carotid artery and vertebral arteries.
  8. Aortic arch anatomical anomalies that preclude the safe placement of the device.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744523

Locations
United States, New York
University at Buffalo Neurosurgery
Buffalo, New York, United States, 14209
United States, Ohio
MidWest Cardiology Research Foundation
Columbus, Ohio, United States, 43214
Sponsors and Collaborators
Medtronic Endovascular
Investigators
Principal Investigator: Gary Ansel, MD Midwest Cardiology Research Foundation
Principal Investigator: L. Nelson Hopkins, MD University at Buffalo Neurosurgery
  More Information

No publications provided

Responsible Party: Steven R. Camp, Invatec Inc.
ClinicalTrials.gov Identifier: NCT00744523     History of Changes
Other Study ID Numbers: P-2850
Study First Received: August 29, 2008
Results First Received: March 10, 2010
Last Updated: January 25, 2012
Health Authority: United States: Food and Drug Administration
Italy: Ministry of Health

Keywords provided by Medtronic Endovascular:
carotid artery stenting
stroke
cerebral protection
high surgical risk

Additional relevant MeSH terms:
Carotid Artery Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014