Prevention of Restenosis Following Revascularization

This study has been terminated.

(Study was terminated due to changing sponsor priorities, and was not based on safety or outcomes data.)

Sponsor:

Information provided by (Responsible Party):

Celgene Corporation

ClinicalTrials.gov Identifier:

NCT00518284

First received: August 16, 2007

Last updated: February 21, 2012

Last verified: February 2012

History of Changes

Results First Received: February 21, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Vascular Disease, Peripheral
Intervention:	Drug: Nanoparticle Paclitaxel

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
Control	Following revascularization, participants did not receive any study drug treatment.
Proximal to Lesion + IV	Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
During Flow Arrest	Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
During Flow Arrest + IV	Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.

Participant Flow: Overall Study

	Proximal to Lesion + IV	During Flow Arrest	During Flow Arrest + IV
STARTED	3	1	2
COMPLETED	0	0	0
NOT COMPLETED	3	1	2
Adverse Event	1	0	0
Study Termination	2	1	2

Baseline Characteristics

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Reporting Groups

	Description
Control	Following revascularization, participants did not receive any study drug treatment.
Proximal to Lesion + IV	Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
During Flow Arrest	Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
During Flow Arrest + IV	Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
Total	Total of all reporting groups

Baseline Measures

	Control	Proximal to Lesion + IV	During Flow Arrest	During Flow Arrest + IV	Total
Number of Participants [units: participants]	0	3	1	2	6
Age [units: years] Mean ± Standard Deviation		69.7 ± 10.50	84.0 ± NA ^[1]	69.0 ± 12.73	71.8 ± 10.59
Gender [units: participants]
Female		0	0	1	1
Male		3	1	1	5
Race/Ethnicity, Customized [units: participants]
Asian		0	0	1	1
White, Non-Hispanic and Non-Latino		3	1	1	5

[1]	Standard deviation could not be calculated as only one patient was randomized to this treatment group.

Outcome Measures

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1. Primary:

Target Vessel Revascularization at 9 Months [ Time Frame: 9 months ]

Show Outcome Measure 1

2. Secondary:

Systolic Velocity Ratio (SVR) > 2.0 [ Time Frame: 9 months ]

Show Outcome Measure 2

3. Secondary:

Change From Baseline in Walking Impairment Questionnaire (WIQ) Score [ Time Frame: Baseline and Month 9 ]

Show Outcome Measure 3

4. Secondary:

Decrease in Ankle Brachial Index (ABI) > 0.15 [ Time Frame: Baseline and Month 9 ]

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5. Secondary:

Target Lesion Revascularization (TLR) at 9 Months [ Time Frame: 9 months ]

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6. Secondary:

Number of Deaths [ Time Frame: Up to 11 months ]

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7. Secondary:

Number of Participants With Myocardial Infarction (MI) [ Time Frame: Up to 11 months ]

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Measure Type	Secondary
Measure Title	Number of Participants With Myocardial Infarction (MI)
Measure Description	The number of patients experiencing Myocardial Infarction (MI) during the study. Myocardial Infarction was defined as new pathologic Q waves of at least 0.04 seconds, or an increase in serum creatine kinase to more than twice the normal code together with a pathologic increase in myocardial isoenzymes.
Time Frame	Up to 11 months
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated population.

Reporting Groups

	Description
Control	Following revascularization, participants did not receive any study drug treatment.
Proximal to Lesion + IV	Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
During Flow Arrest	Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
During Flow Arrest + IV	Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.

Measured Values

	Control	Proximal to Lesion + IV	During Flow Arrest	During Flow Arrest + IV
Number of Participants Analyzed [units: participants]	0	3	1	2
Number of Participants With Myocardial Infarction (MI) [units: participants]		0	0	0

No statistical analysis provided for Number of Participants With Myocardial Infarction (MI)

8. Secondary:

Number of Participants With a Stroke [ Time Frame: Up to 11 months ]

Show Outcome Measure 8

9. Secondary:

Minimum Lumen Diameter [ Time Frame: 9 months ]

Show Outcome Measure 9

10. Secondary:

Late Loss [ Time Frame: Day 1 (following revascularization) and 9 months ]

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11. Secondary:

Percentage of Participants With Binary Restenosis [ Time Frame: 9 months ]

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12. Secondary:

Diameter Stenosis [ Time Frame: 9 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: Study data will not be published in part before complete multicenter data have been reported in full, unless more than 18 months have elapsed since completion of the Study. Investigator/institution must supply copy of presentation or publication to Celgene 30 days of prior to submission for publication. Celgene may request in writing within that 30 days that Celgene Confidential Information be deleted or be granted a 60 day delay prior to publication for intellectual property filings.

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: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
phone: 1-888-260-1599
e-mail: clinicaltrialdisclosure@celgene.com

No publications provided

Responsible Party:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00518284 History of Changes
Other Study ID Numbers:	CVR002
Study First Received:	August 16, 2007
Results First Received:	February 21, 2012
Last Updated:	February 21, 2012
Health Authority:	United States: Food and Drug Administration

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