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

History of Changes

Results First Received: March 10, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Prevention
Conditions:	Carotid Artery Disease Stroke Prevention
Intervention:	Device: Carotid Artery Stenting with cerebral protection with the MO.MA device

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The trial was approved to enroll subjects from a maximum of 25 (combined United States [US] and Europe [EU]) medical institutions (public and academic research center hospitals). Subjects were enrolled from September 2007 to February 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
MO.MA Roll-In Cases	All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
MO.MA Pivotal Subjects	All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device

Participant Flow for 2 periods

Period 1: Procedure

	MO.MA Roll-In Cases	MO.MA Pivotal Subjects
STARTED	37	225
COMPLETED	37	225
NOT COMPLETED	0	0

Period 2: 30 Days After the Procedure

	MO.MA Roll-In Cases	MO.MA Pivotal Subjects
STARTED	37	225
COMPLETED	37	220
NOT COMPLETED	0	5
Insufficient follow-up	0	5

Baseline Characteristics

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Reporting Groups

	Description
MO.MA Roll-In Cases	All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
MO.MA Pivotal Subjects	All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
Total	Total of all reporting groups

Baseline Measures

	MO.MA Roll-In Cases	MO.MA Pivotal Subjects	Total
Number of Participants [units: participants]	37	225	262
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	6	37	43
>=65 years	31	188	219
Age, Customized [units: participants]
< 80 years	26	160	186
>= 80 years	11	65	76
Age [units: years] Mean ± Standard Deviation	74.28 ± 10.38	74.66 ± 8.54	74.61 ± 8.80
Gender [units: participants]
Female	12	75	87
Male	25	150	175
Region of Enrollment [units: participants]
United States	37	147	184
Europe	0	78	78
History of Diabetes [units: participants]
Yes	15	83	98
No	21	141	162
No Response	1	1	2
History of Hypertension [units: participants]
Yes	32	196	228
No	5	29	34
Symptomatic [1] ^[1] [units: participants]
Symptomatic	8	34	42
Asymptomatic	29	191	220

[1]	[1]Presence of baseline neurological symptoms within 6 months prior to enrollment.

Outcome Measures

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1. Primary:

Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure. [ Time Frame: Up to 30 days after the procedure was performed ]

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2. Secondary:

Device Success [ Time Frame: The entire duration of the index procedure ]

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3. Secondary:

Technical Success [ Time Frame: The entire duration of the index procedure ]

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4. Secondary:

Procedural Success [ Time Frame: The entire duration of the index procedure through hospital discharge ]

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5. Secondary:

Restenosis at 30 Days [ Time Frame: Up to 30 days after the procedure was performed ]

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6. Secondary:

Target Lesion Revascularization at 30 Days [ Time Frame: Up to 30 days after the procedure was performed ]

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7. Secondary:

Access Site Adverse Events [ Time Frame: Index Procedure through Hospital Discharge ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Steve Camp, Vice President Clinical and Regulatory Affairs
Organization: Invatec, Inc.
phone: (610) 625-1402
e-mail: steve.camp@invatec.com

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

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