- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00715884
Study Comparing the CYPHER® ELITE™ to the CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems (ELITE)
December 17, 2013 updated by: Cordis Corporation
A Prospective, Single-Blind, Randomized, Multi-Center Study Comparing the CYPHER® ELITE™ to the CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems (ELITE).
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
678
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Washington Hospital Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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%;
- Impaired renal function (creatinine > 250 μmol/L or > 2.5 mg/dl) at the time of treatment;
- Pretreatment with devices other than conventional balloon angioplasty;
- Significant angulation in the target vessel that, in the Investigator's opinion, may preclude stent delivery and deployment;
- Subject previously treated with brachytherapy;
- Recipient of heart transplant;
- Subject with a life expectancy less than 12 months;
- Known allergies to the following: aspirin, clopidogrel bisulfate and ticlopidine, heparin, stainless steel, contrast agent (that cannot be managed medically), or sirolimus that cannot be managed medically;
- Any significant medical condition which, in the Investigator's opinion, may interfere with the subject's optimal participation in the study;
- Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the study endpoints;
- In the Investigator's opinion, the lesion is not suitable for stenting;
- Known bleeding or hypercoagulable disorder;
- Known or suspected active infection at the time of the study procedures;
- Subject is known to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser;
- Subject has had major surgical or interventional procedures unrelated to this study within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
CYPHER® ELITE™ Sirolimus-Eluting Stent System.
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Drug eluting stent
Other Names:
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Active Comparator: 2
CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
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Drug eluting stent
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Who Experienced Target Lesion Failure (TLF)
Time Frame: 12-months post-procedure
|
The primary endpoint for this study is the percentage of participants who experienced Target Lesion Failure (TLF) during the 12 months post-procedure.
A TLF event is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.
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12-months post-procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Lesion Success
Time Frame: At procedure
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Lesion success is defined as the attainment of < 50 percent residual stenosis (by Quantitative Coronary Angiography (QCA)) using any percutaneous method.
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At procedure
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Percentage of Device Success - Protocol Definition
Time Frame: At procedure
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Device success is defined as achievement of a final residual diameter stenosis of <50 percent (by QCA), using the assigned device only.
If QCA was not available, the visual estimate of diameter stenosis was used.
Device success was based on the following two measurements.
Protocol definition: Only protocol-defined study stents were included.
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At procedure
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Percentage of Device Success - All CYPHER® Stents Included
Time Frame: At procedure
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Device success is defined as achievement of a final residual diameter stenosis of <50 percent (by QCA), using the assigned device only.
If QCA was not available, the visual estimate of diameter stenosis was used.
Device success was based on the following two measurements.
All CYPHER® Stents were included if the final residual stenosis was <50%.
Non-study CYPHER® Stents were also included.
|
At procedure
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Percentage of Participants Who Achieved Procedure Success
Time Frame: At procedure during hospital stay
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Procedure success is defined as achievement of a final diameter stenosis of < 50 percent (by QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion during the hospital stay.
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At procedure during hospital stay
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Percentage of Participants Who Experienced Target Lesion Revascularization (TLR)
Time Frame: 12 months post-procedure
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TLR is defined as any "clinically-driven" repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel.
Clinically-driven revascularizations are those in which the patient has a positive functional study, ischemic electrocardiogram (ECG) changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis 50 percent by QCA.
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12 months post-procedure
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Percentage of Participants Who Experienced Target Vessel Revascularization (TVR)
Time Frame: 12 months post procedure
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TVR is defined as any "clinically driven" repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.
Clinically-driven revascularizations are those in which the patient has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis 50 percent by QCA.
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12 months post procedure
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Percentage of Participants Who Experienced Target Vessel Failure (TVF)
Time Frame: 12 months post procedure
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Target Vessel failure is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.
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12 months post procedure
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Percentage of Participants Who Experienced Major Adverse Cardiac Events (MACE)
Time Frame: 12 months post procedure
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MAJOR ADVERSE CARDIAC EVENTS (MACE) consists of death, myocardial infarction, emergent bypass surgery, and target lesion revascularization.
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12 months post procedure
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Percentage of Participants Who Had Lesions of More Than 1 Vessel and Experienced Target Lesion Failure (TLF)
Time Frame: 12 months post procedure
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A Target Lesion Failure is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.
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12 months post procedure
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Percentage of Participants Who Had Diabetes and Experienced Target Lesion Failure (TLF)
Time Frame: 12 months post procedure
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A Target Lesion Failure is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.
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12 months post procedure
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Percentage of Participants Who Experienced Bleeding Complications
Time Frame: 12 months post procedure
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Bleeding complications include any bleeding events defined by THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI), Global Strategies for Opening Occluded Coronary Arteries (GUSTO), and "Protocol" definitions.
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12 months post procedure
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Percentage of Participants Who Died
Time Frame: 12 months post procedure
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Death incidences include both Cardiac and non-cardiac death.
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12 months post procedure
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Percentage of Participants Who Experienced Any Myocardial Infarction (MI)
Time Frame: 12 months post procedure
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Myocardial Infarction includes both Q-wave and WHO Non-Q Wave Myocardial Infarction events.
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12 months post procedure
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Percentage of Participants Who Experienced Stroke
Time Frame: 12 months post procedure
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The stroke definition includes both hemorrhagic and non-hemorrhagic strokes.
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12 months post procedure
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Percentage of Participants Who Experienced Stent Thrombosis (Protocol Definition)
Time Frame: 12 months post procedure
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Protocol defined Stent thrombosis include both Early and Late Thrombosis.
Early thrombosis is defined as composite thirty-day ischemic endpoint including death, Q-wave MI, or subabrupt closure requiring revascularization.
Late thrombosis is defined as myocardial infarction occurring > 30 days after the index procedure and attributable to the target vessel with angiographic documentation (site-reported or by qualitative coronary angiography) of thrombus or total occlusion at the target site and freedom from an interim revascularization of the target vessel.
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12 months post procedure
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Percentage of Participants Who Experienced Stent Thrombosis (Academic Research Consortium (ARC) Definition)
Time Frame: 12 months post procedure
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Academic Research Consortium (ARC) defines STENT THROMBOSIS as consisting of the following:
ARC Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. |
12 months post procedure
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Percentage of Participants Who Experienced Early Stent Thrombosis (Academic Research Consortium (ARC) Definition)
Time Frame: 0-30 days post-procedure
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Those ARC stent thromboses occurred between 0 and 30 days post-procedure are early stent thrombosis.
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0-30 days post-procedure
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Percentage of Participants Who Experienced Late Stent Thrombosis (Academic Research Consortium (ARC) Definition)
Time Frame: 31-360 days post-procedure
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Those ARC stent thromboses occurred between 31 to 360 days post-procedure are late stent thrombosis.
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31-360 days post-procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lowell Satler, MD, MedStar Health Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
March 1, 2010
Study Completion (Anticipated)
September 1, 2014
Study Registration Dates
First Submitted
July 11, 2008
First Submitted That Met QC Criteria
July 11, 2008
First Posted (Estimate)
July 15, 2008
Study Record Updates
Last Update Posted (Estimate)
January 20, 2014
Last Update Submitted That Met QC Criteria
December 17, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Myocardial Ischemia
- Atherosclerosis
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Sirolimus
Other Study ID Numbers
- P07-6330
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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