GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

W.L.Gore & Associates

ClinicalTrials.gov Identifier:

NCT00541307

First received: October 9, 2007

Last updated: November 26, 2012

Last verified: November 2012

History of Changes

Results First Received: June 22, 2012

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Peripheral Vascular Diseases
Intervention:	Device: Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

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 Viabahn Endoprosthesis	All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.

Participant Flow: Overall Study

	Gore Viabahn Endoprosthesis
STARTED	119
COMPLETED	95
NOT COMPLETED	24
Death	5
Physician Decision	3
Withdrawal by Subject	6
Lost to Follow-up	4
Subject returned early (outside window)	1
Surgical Bypass	5

Baseline Characteristics

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Reporting Groups

	Description
Enrolled Subjects	The total number of enrolled subjects.

Baseline Measures

	Enrolled Subjects
Number of Participants [units: participants]	119
Age [units: participants]
<=18 years	0
Between 18 and 65 years	58
>=65 years	61
Age [units: years] Mean ± Standard Deviation	66 ± 9.6
Gender [units: participants]
Female	45
Male	74
Region of Enrollment [units: participants]
United States	119

Outcome Measures

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1. Primary:

Primary Patency at 12 Months [ Time Frame: 12 months ]

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2. Secondary:

Proportion of Subjects Who Experience Major Device-related Adverse Events Within the First 30 Days [ Time Frame: 30 days ]

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3. Secondary:

Primary Assisted Patency [ Time Frame: 12 months ]

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4. Secondary:

Secondary Patency [ Time Frame: 12 months ]

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5. Secondary:

Device-related Major Adverse Events at 12 Months [ Time Frame: 12 months ]

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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: The investigator will provide the materials to the sponsor at least 30 days in advance of submission for publication or public disclosure. The sponsor has the right to make modifications as necessary to protect proprietary information or correct inaccuracies in technical specifications or device descriptions.

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: Chad Badorek
Organization: W. L. Gore & Associates, Inc.
phone: 928/437-8181
e-mail: cbadorek@wlgore.com

No publications provided

Responsible Party:	W.L.Gore & Associates
ClinicalTrials.gov Identifier:	NCT00541307 History of Changes
Other Study ID Numbers:	VPR 07-03
Study First Received:	October 9, 2007
Results First Received:	June 22, 2012
Last Updated:	November 26, 2012
Health Authority:	United States: Institutional Review Board

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