A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms (AAA IDE)

This study has been completed.

Sponsor:

Information provided by:

Boston Scientific Corporation

ClinicalTrials.gov Identifier:

NCT00646048

First received: March 26, 2008

Last updated: January 26, 2011

Last verified: January 2011

History of Changes

Results First Received: June 29, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Abdominal Aortic Aneurysm
Intervention:	Device: TriVascular Stent-Graft System

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
TriVascular Stent Graft	This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.

Participant Flow: Overall Study

	TriVascular Stent Graft
STARTED	43
COMPLETED	27
NOT COMPLETED	16

Baseline Characteristics

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Reporting Groups

	Description
TriVascular Stent Graft	This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.

Baseline Measures

	TriVascular Stent Graft
Number of Participants [units: participants]	43
Age [units: participants]
<=18 years	0
Between 18 and 65 years	4
>=65 years	39
Age [units: years] Mean ± Standard Deviation	73.1 ± 7.9
Gender [units: participants]
Female	7
Male	36
Region of Enrollment [units: participants]
United States	43

Outcome Measures

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1. Primary:

Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure. [ Time Frame: 1 month ]

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2. Primary:

Number of Participants Without a Type I, III, and/or IV Endoleak at 1 Month Follow-up Identified by Computed Tomography (CT). [ Time Frame: 1 month ]

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3. Secondary:

Number of Participants Who Achieve Technical Success of the Stent Graft System. [ Time Frame: Post procedure ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	Baseline through 5 year follow-up.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
TriVascular Stent Graft	This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.

Other Adverse Events

	TriVascular Stent Graft
Total, other (not including serious) adverse events
# participants affected / at risk	33/43
General disorders
Catheter site haematoma ^{† 1}
# participants affected / at risk	3/43 (6.98%)
# events	3
Catheter site related reaction ^{† 1}
# participants affected / at risk	3/43 (6.98%)
# events	3
Injury, poisoning and procedural complications
Device breakage ^{† 1}
# participants affected / at risk	12/43 (27.91%)
# events	12
Stent-graft endoleak ^{† 1}
# participants affected / at risk	3/43 (6.98%)
# events	4
Musculoskeletal and connective tissue disorders
Back pain ^{† 1}
# participants affected / at risk	4/43 (9.30%)
# events	4
Vascular disorders
Intermittent claudication ^{† 1}
# participants affected / at risk	8/43 (18.60%)
# events	8

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA (10.1)

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: No text entered.

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: Colleen Holthe, Clinical Project Manager
Organization: Boston Scientific
phone: 651-581-4632
e-mail: Colleen.Holthe@bsci.com

No publications provided

Responsible Party:	Colleen Holthe, Boston Scientific
ClinicalTrials.gov Identifier:	NCT00646048 History of Changes
Other Study ID Numbers:	S2106
Study First Received:	March 26, 2008
Results First Received:	June 29, 2010
Last Updated:	January 26, 2011
Health Authority:	United States: Food and Drug Administration

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