Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) (PROTECT)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Abbott Vascular

ClinicalTrials.gov Identifier:

NCT00402740

First received: November 20, 2006

Last updated: May 17, 2012

Last verified: May 2012

History of Changes

Results First Received: May 7, 2012

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Carotid Artery Disease
Intervention:	Device: Xact Stent with either Emboshield Pro (Gen 5) or Emboshield (Gen 3)

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
A total of 322 subjects were enrolled in the PROTECT study at 38 clinical sites in the United States. The first subject was enrolled on November 29, 2006, and enrollment was completed on June 18, 2008.

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
Group 1	No text entered.

Participant Flow: Overall Study

	Group 1
STARTED	322
COMPLETED	242
NOT COMPLETED	80
Withdrawal by Subject	18
Death	50
Lost to Follow-up	6
No stent. Completed FU at 30 days.	5
Subject disposition unknown.	1

Baseline Characteristics

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Reporting Groups

	Description
Group 1	No text entered.

Baseline Measures

	Group 1
Number of Participants [units: participants]	322
Age [units: participants]
<=18 years	0
Between 18 and 65 years	71
>=65 years	251
Age [units: years] Mean ± Standard Deviation	72.7 ± 9.8
Gender [units: participants]
Female	115
Male	207
Region of Enrollment [units: participants]
United States	322

Outcome Measures

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1. Primary:

Kaplan-Meier Estimate of Freedom From the Composite of Any Death, Stroke and MI During the 30 Day Post Procedural Period (DSMI), Plus Fatal and Non-fatal Ipsilateral Stroke From 31-365 Days and Annually Thereafter for a Total of 3 Years. [ Time Frame: 3 years ]

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2. Secondary:

Acute Device Success [ Time Frame: Post-procedure ]

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3. Secondary:

Procedural Success [ Time Frame: 30 Days ]

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4. Secondary:

Composite of Any Transient Ischemic Attack (TIA) and Amaurosis Fugax [ Time Frame: ≤30 days ]

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5. Secondary:

Kapan-Meier Estimate of Freedom From Clinically Driven Target Lesion Revascularization Through Three Years. [ Time Frame: 3 years ]

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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. Restriction Description: Principal Investigator (PI), Institute, and Research Site (RS) acknowledge this is a multi-center study. An independent, joint publication is anticipated from investigators in the study, including the PI. Therefore, the PI, Institute, and RS agree not to publish or present the results before the publication of the multi-center investigator paper, but in no event shall PI, Institute, and/or RS be so restricted after the expiration of twelve months from completion of the Study at all sites.

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: Ellen Travis, MS, NFP
Organization: Abbott Vascular
phone: 408 845-1512
e-mail: Ellen.Travis@av.abbott.com

No publications provided

Responsible Party:	Abbott Vascular
ClinicalTrials.gov Identifier:	NCT00402740 History of Changes
Other Study ID Numbers:	640-0071
Study First Received:	November 20, 2006
Results First Received:	May 7, 2012
Last Updated:	May 17, 2012
Health Authority:	United States: Food and Drug Administration

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