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Study Comparing the CYPHER® ELITE™ to the CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems | Clinical Trials | Clareo Health

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Study Comparing the CYPHER® ELITE™ to the CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems

A Prospective, Single-Blind, Randomized, Multi-Center Study Comparing the CYPHER® ELITE™ to the CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems (ELITE).

NCT00715884•Cordis US Corp.

View on ClinicalTrials.gov

Summary

The objective of this study is to show similar (non-inferior) safety and effectiveness between CYPHER® ELITE™ and CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems in a prospective, multi-center, randomized clinical study for the treatment of de novo native coronary lesions.

Detailed Description

A prospective, single-blind, randomized, multicenter, two arm study. The objective of this study is to show similar (non-inferior) safety and effectiveness between CYPHER® ELITE™ and CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems in a prospective, multi-center, randomized clinical study for the treatment of de novo native coronary lesions.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects with de novo atherosclerotic CAD in 1 or 2 vessels;
•The subject must be \>/= 18 years of age;
•Female of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment;
•Diagnosis of angina pectoris as defined by stable angina pectoris Canadian Cardiovascular Society Classification (Class I, II, III) OR non-ST segment elevation acute coronary syndrome (Braunwald Classification B\&C) OR non-ST segment elevation myocardial infarction \>/= 48 hours from the time of study index procedure OR asymptomatic subjects with a positive stress test;
•Treatment of \</= two lesions in one or two major coronary arteries (1 target lesion in each of 2 vessels or 2 target lesions in 1 vessel);
•Target vessel diameter must be \>/= 2.25mm and \</= 4.0 in diameter (visual estimate);
•Target lesion stenosis is \> 50% and \< 100% (visual estimate);
•Target lesion length \<30mm (for each target lesion(s)) with a total implanted stent length \< 66mm. Additional stents can be used to treat dissections, etc,: however, these must be the same stent to which the subject has been randomized in the study.
•Subject or Legally Authorized Representative must provide written informed consent prior to the procedure using a form that is approved by the Institutional Review Board/Independent Ethics Committee.

Exclusion Criteria

•ST Segment Elevation Myocardial Infarction (STEMI) within 30 days of the study index procedure;
•Unprotected left main coronary disease with \>/= 50% stenosis;
•Total coronary occlusion or TIMI grade 0 or 1 in the target vessel;
•Angiographic evidence of thrombus within target lesion(s);
•Calcified target lesion(s) which cannot be, in the investigator's opinion, successfully pre-dilated;
•Bifurcation disease involving a side branch \>/= 2 mm in diameter;
•Prior stent within 5 mm of target lesion(s);
•Ostial target lesion(s);
•Target lesion(s) within a coronary bypass graft (e.g., saphenous vein or arterial graft);
•Documented left ventricular ejection fraction \</= 25%;
+14 more criteria

Locations (1)

Washington Hospital Center

Washington D.C., District of Columbia, United States

Key Dates

Start Date

July 1, 2008

Primary Completion Date

March 1, 2010

Completion Date

September 1, 2014

Last Updated

January 20, 2014

Enrollment

678

ACTUAL participants

Conditions

Coronary Artery DiseaseCoronary Atherosclerosis

Interventions

CYPHER® ELITE™ Sirolimus-Eluting Stent System

DEVICE

CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System

DEVICE

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

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Coronary Artery Disease

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"Erectile Function After PCI in MI and Non-MI Patients"

NCT07444697

Erectile DisfunctionCoronary Artery Disease (CAD)+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 20, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study Comparing the CYPHER® ELITE™ to the CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems

Inclusion Criteria

Exclusion Criteria

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