NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions

This study has been completed.

Study NCT00231283 Information provided by Cordis Corporation

First Received on September 30, 2005. Last Updated on April 13, 2010 History of Changes

Results First Received: November 18, 2008

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Coronary Artery Disease
Intervention:	Device: CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)

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
First patient enrolled was Apr 2004 and last patient enrolled was Jul 2004.

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
CYPHER NxT Stent on the BX SONIC OTW SDS	CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System

Participant Flow: Overall Study

	CYPHER NxT Stent on the BX SONIC OTW SDS
STARTED	100
COMPLETED	95
NOT COMPLETED	5

Baseline Characteristics

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Reporting Groups

	Description
CYPHER NxT Stent on the BX SONIC OTW SDS	CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System

Baseline Measures

	CYPHER NxT Stent on the BX SONIC OTW SDS
Number of Participants [units: participants]	100
Age [units: participants]
<=18 years	0
Between 18 and 65 years	49
>=65 years	51
Age [units: years] Mean ± Standard Deviation	64.39 ± 10.80
Gender [units: participants]
Female	32
Male	68
Region of Enrollment [units: participants]
United States	100
Patients with Diabetes Mellitus [units: participants]
With Diabetes Mellitus	25
Without Diabetes Mellitus	75

Outcome Measures

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1. Primary:

Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge [ Time Frame: From post-procedure up to hospital discharge ]

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2. Secondary:

Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 30 Days Later [ Time Frame: From post-procedure up to 30 days ]

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3. Secondary:

Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to Hospital Discharge [ Time Frame: From post-procedure up to hospital discharge ]

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4. Secondary:

Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 12 Months Later [ Time Frame: From post-procedure 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: Sidney Cohen, MD PhD, Vice President
Organization: Cordis
phone: 650 614-2726
e-mail: scohen7@its.jnj.com

No publications provided

Responsible Party:	Sidney Cohen, MD, PhD, Vice President, Cordis
ClinicalTrials.gov Identifier:	NCT00231283 History of Changes
Other Study ID Numbers:	P04-6324
Study First Received:	September 30, 2005
Results First Received:	November 18, 2008
Last Updated:	April 13, 2010
Health Authority:	United States: Food and Drug Administration