AngioSculpt® Coronary Bifurcation Study (AGILITY)

This study has been completed.

Sponsor:

Information provided by:

AngioScore, Inc.

ClinicalTrials.gov Identifier:

NCT00686647

First received: May 28, 2008

Last updated: July 14, 2011

Last verified: July 2011

History of Changes

Results First Received: June 17, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Coronary Artery Disease Myocardial Ischemia
Interventions:	Device: AngioSculpt® Scoring Balloon Catheter Device: AngioSculpt Scoring Balloon Catheter

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
AngioSculpt Device	No text entered.

Participant Flow: Overall Study

	AngioSculpt Device
STARTED	93
COMPLETED	91
NOT COMPLETED	2
Lost to Follow-up	1
Death	1

Baseline Characteristics

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Reporting Groups

	Description
AngioSculpt Device	No text entered.

Baseline Measures

	AngioSculpt Device
Number of Participants [units: participants]	93
Age [units: participants]
<=18 years	0
Between 18 and 65 years	57
>=65 years	36
Age [units: years] Mean ± Standard Deviation	61.54 ± 11.6
Gender [units: participants]
Female	26
Male	67
Region of Enrollment [units: participants]
United States	93

Outcome Measures

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1. Primary:

Procedural Success [ Time Frame: 1 day ]

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2. Secondary:

Major Adverse Cardiovascular Events [ Time Frame: 30 days ]

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3. Secondary:

Major Adverse Cardiac Events [ Time Frame: 9 months ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
AngioSculpt Device	No text entered.

Other Adverse Events

	AngioSculpt Device
Total, other (not including serious) adverse events
# participants affected / at risk	7/93
Cardiac disorders
Chest pain ^*
# participants affected / at risk	7/93 (7.53%)
# events	7

*	Events were collected by non-systematic assessment

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: Prior to submission, the Sponsor, Institution, and Site Investigators will review and authorize the publication. A review period of 15 days for Presentational materials and abstracts; and 30 days for manuscripts is required for the Sponsor's review. Sponsor review does not include editorial privileges but can protect proprietary information and correct errors in data reporting or analysis if the Investigator agrees that there is an error.

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: Gary Gershony, MD/ Chief Medical Officer
Organization: AngioScore
phone: 510-933-7900
e-mail: gary@angioscore.com

No publications provided

Responsible Party:	Gary Gershony, M.D., Chief Medical Officer, AngioScore, Inc.
ClinicalTrials.gov Identifier:	NCT00686647 History of Changes
Other Study ID Numbers:	ASC-ST1210
Study First Received:	May 28, 2008
Results First Received:	June 17, 2011
Last Updated:	July 14, 2011
Health Authority:	United States: Institutional Review Board

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