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

Cordis US Corp.678 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

678

Conditions

Coronary Artery Disease Coronary Atherosclerosis

Interventions

CYPHER® ELITE™ Sirolimus-Eluting Stent SystemDEVICE

Drug eluting stent

CYPHER® Bx VELOCITY® Sirolimus-eluting Stent SystemDEVICE

Drug eluting stent

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Washington Hospital Center

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

Outcomes

Primary Outcomes

Percentage of Participants Who Experienced Target Lesion Failure (TLF)

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.

Time frame: 12-months post-procedure

Secondary Outcomes

Percentage of Lesion Success

Lesion success is defined as the attainment of \< 50 percent residual stenosis (by Quantitative Coronary Angiography (QCA)) using any percutaneous method.

Time frame: At procedure

Percentage of Device Success - Protocol Definition

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.

Time frame: At procedure

Percentage of Device Success - All CYPHER® Stents Included

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.

Time frame: At procedure

Percentage of Participants Who Achieved Procedure Success

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.

Data from ClinicalTrials.gov

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Time frame: At procedure during hospital stay

Percentage of Participants Who Experienced Target Lesion Revascularization (TLR)

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.

Time frame: 12 months post-procedure

Percentage of Participants Who Experienced Target Vessel Revascularization (TVR)

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.