Proximal Protection With The Mo.Ma Device During Carotid Stenting

NCT00744523 | Completed Results DMC

• 1 other identifier: P-2850
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 2

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

Conditions

Carotid Artery Disease

Keywords

carotid artery stenting; stroke; cerebral protection; high surgical risk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Device Success

  The entire duration of the index procedure

• Technical Success

  The entire duration of the index procedure

• Procedural Success

  The entire duration of the index procedure through hospital discharge

• Restenosis at 30 Days

  Up to 30 days after the procedure was performed

• Target Lesion Revascularization at 30 Days

  Up to 30 days after the procedure was performed

Study Arms (1)

Mo.ma cerebral protection device

EXPERIMENTAL

Mo.Ma cerebral protection device

Device: Mo.Ma cerebral protection device

Interventions

Mo.Ma cerebral protection device DEVICE

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.

Also known as: Mo.Ma

Mo.ma cerebral protection device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Endovascular: lead

Study Sites (2)

University at Buffalo Neurosurgery

Buffalo, New York, 14209, United States

Location

MidWest Cardiology Research Foundation

Columbus, Ohio, 43214, United States

Location

MeSH Terms

Conditions

Carotid Artery Diseases; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Arslan Malik, Senior Clinical Research Manager
• Organization: Medtronic Aortic and Peripheral Vascular

arslan.malik@medtronic.com

(707) 541-3256

Study Officials

• Gary Ansel, MD

  Midwest Cardiology Research Foundation

  PRINCIPAL INVESTIGATOR

• L. Nelson Hopkins, MD

  University at Buffalo Neurosurgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2008
• First Posted: September 1, 2008
• Study Start: September 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: February 26, 2016
• Results First Posted: May 5, 2010

Record last verified: 2016-01

Locations

US (2)