Celect Vena Cava Filter Clinical Trial

This study has been completed.

Study NCT00470626 Information provided by Cook

First Received on September 14, 2005. Last Updated on April 12, 2010 History of Changes

Results First Received: February 3, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Pulmonary Embolism Venous Thromboembolism
Intervention:	Device: Celect Vena Cava Filter

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
Celect Vena Cava Filter	No text entered.

Participant Flow: Overall Study

	Celect Vena Cava Filter
STARTED	129
COMPLETED	112
NOT COMPLETED	17
Lost to Follow-up	10
Withdrawal by Subject	7

Baseline Characteristics

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Reporting Groups

	Description
Celect Vena Cava Filter	No text entered.

Baseline Measures

	Celect Vena Cava Filter
Number of Participants [units: participants]	129
Age [units: years] Mean ± Standard Deviation	51 ± 19
Gender [units: participants]
Female	58
Male	71
Cancer [units: participants]
Cancer	23
No Cancer	106
Coagulation Disorder [units: participants]
Coagulation Disorder	4
No Coagulation Disorder	125
Congestive Heart Failure (CHF) [units: participants]
CHF	1
No CHF	128
Coronary Heart Disease (CHD) [units: participants]
CHD	1
No CHD	128
Current Deep Venous Thrombosis (DVT) [units: participants]
Current DVT	72
No Current DVT	57
Current Pulmonary Embolism (PE) [units: participants]
Current PE	50
No Current PE	79
Diabetes [units: participants]
Diabetes Type I	2
Diabetes Type II	10
No Diabetes	117
Gastrointestinal (GI) Disease [units: participants]
GI Disease	8
No GI Disease	121
Hepatic Disease [units: participants]
Hepatic Disease	3
No Hepatic Disease	126
Hypertension [units: participants]
Hypertension	0
No Hypertension	129
Peripheral Vascular Disease (PVD) [units: participants]
PVD	7
No PVD	122
Pulmonary Disease [units: participants]
Pulmonary Disease	33
No Pulmonary Disease	96
Renal Disease [units: participants]
Renal Disease	5
No Renal Disease	124
Stroke [units: participants]
Stroke	7
No Stroke	122
Trauma [units: participants]
Trauma	38
No Trauma	91

Outcome Measures

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1. Primary:

Major Adverse Event [ Time Frame: up to 12 months ]

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2. Secondary:

Successful Retrieval [ Time Frame: up to 12 months ]

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3. Secondary:

Mean Time to Retrieval Attempt [ Time Frame: up to 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.

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: Scott Snyder
Organization: Cook
phone: 765-463-7537
e-mail: ssnyder@medinst.com

Publications of Results:

Lyon SM, Riojas GE, Uberoi R, Patel J, Lipp ME, Plant GR, De Gregorio MA, Günther RW, Voorhees WD, McCann-Brown JA. Short- and long-term retrievability of the Celect vena cava filter: results from a multi-institutional registry. J Vasc Interv Radiol. 2009 Nov;20(11):1441-8.

Responsible Party:	Michael Seest, William Cook Europe
ClinicalTrials.gov Identifier:	NCT00470626 History of Changes
Other Study ID Numbers:	05-507, 110006, GTMX
Study First Received:	September 14, 2005
Results First Received:	February 3, 2010
Last Updated:	April 12, 2010
Health Authority:	Mexico: Federal Commission for Sanitary Risks Protection; Australia: Department of Health and Ageing Therapeutic Goods Administration; Germany: Ethics Commission; Spain: Spanish Agency of Medicines