Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

W.L.Gore & Associates

ClinicalTrials.gov Identifier:

NCT00874250

First received: March 31, 2009

Last updated: February 12, 2013

Last verified: February 2013

History of Changes

Results First Received: September 22, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Aneurysm
Intervention:	Device: GORE CTAG 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
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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
GORE CTAG Device	The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis.

Participant Flow: Overall Study

	GORE CTAG Device
STARTED	51
COMPLETED	0
NOT COMPLETED	51

Baseline Characteristics

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Reporting Groups

	Description
GORE CTAG Device	The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis.

Baseline Measures

	GORE CTAG Device
Number of Participants [units: participants]	51
Age [units: years] Mean ± Standard Deviation	71.9 ± 9.8
Gender [units: participants]
Female	17
Male	34
Region of Enrollment [units: participants]
United States	51

Outcome Measures

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1. Primary:

The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment [ Time Frame: Treatment through 1 month post treatment ]

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2. Secondary:

The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment. [ Time Frame: Treatment through 1 month post procedure ]

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3. Secondary:

Procedure Time [ Time Frame: Initial Device Implant Procedure During Index Hospitalization ]

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4. Secondary:

Operative Blood Loss [ Time Frame: Initial Device Implant Procedure During Index Hospitalization ]

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5. Secondary:

Convalescence Stay in an Intensive Care Unit [ Time Frame: During the Index Hospitalization ]

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6. Secondary:

Total Length of Hospital Stay [ Time Frame: Total Duration of the Index Hospitalization ]

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7. Secondary:

Time to Return to Normal Daily Activities [ Time Frame: Average time of one month ]

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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: Gore has the right to review disclosures, requesting a delay of less than 90 days. Each investigator will postpone single center publications until after disclosure of multi-center data, less than 12 months from study completion/termination at all participating 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: Tab Bonny
Organization: W.L. Gore and Associates
phone: 9288644275
e-mail: tbonny@wlgore.com

No publications provided

Responsible Party:	W.L.Gore & Associates
ClinicalTrials.gov Identifier:	NCT00874250 History of Changes
Other Study ID Numbers:	TAG 08-03
Study First Received:	March 31, 2009
Results First Received:	September 22, 2011
Last Updated:	February 12, 2013
Health Authority:	United States: Food and Drug Administration

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