Clinical trial NCT00715884: Study Comparing the CYPHER® ELITE™ to the CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems
Official title: A Prospective, Single-Blind, Randomized, Multi-Center Study Comparing the CYPHER® ELITE™ to the CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems (ELITE).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Coronary Atherosclerosis
Keywords: Atherosclerosis
de novo native coronary lesion
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2008-07-15
Enrollment: 678
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: Percentage of Participants Who Experienced Target Lesion Failure (TLF)
timeFrame: 12-months post-procedure
Secondary outcomes:
measure: Percentage of Lesion Success
timeFrame: At procedure
measure: Percentage of Device Success - Protocol Definition
timeFrame: At procedure
measure: Percentage of Device Success - All CYPHER® Stents Included
timeFrame: At procedure
measure: Percentage of Participants Who Achieved Procedure Success
timeFrame: At procedure during hospital stay
measure: Percentage of Participants Who Experienced Target Lesion Revascularization (TLR)
timeFrame: 12 months post-procedure
measure: Percentage of Participants Who Experienced Target Vessel Revascularization (TVR)
timeFrame: 12 months post procedure
measure: Percentage of Participants Who Experienced Target Vessel Failure (TVF)
timeFrame: 12 months post procedure
measure: Percentage of Participants Who Experienced Major Adverse Cardiac Events (MACE)
timeFrame: 12 months post procedure
measure: Percentage of Participants Who Had Lesions of More Than 1 Vessel and Experienced Target Lesion Failure (TLF)
timeFrame: 12 months post procedure
measure: Percentage of Participants Who Had Diabetes and Experienced Target Lesion Failure (TLF)
timeFrame: 12 months post procedure
measure: Percentage of Participants Who Experienced Bleeding Complications
timeFrame: 12 months post procedure
measure: Percentage of Participants Who Died
timeFrame: 12 months post procedure
measure: Percentage of Participants Who Experienced Any Myocardial Infarction (MI)
timeFrame: 12 months post procedure
measure: Percentage of Participants Who Experienced Stroke
timeFrame: 12 months post procedure
measure: Percentage of Participants Who Experienced Stent Thrombosis (Protocol Definition)
timeFrame: 12 months post procedure
measure: Percentage of Participants Who Experienced Stent Thrombosis (Academic Research Consortium (ARC) Definition)
timeFrame: 12 months post procedure
measure: Percentage of Participants Who Experienced Early Stent Thrombosis (Academic Research Consortium (ARC) Definition)
timeFrame: 0-30 days post-procedure
measure: Percentage of Participants Who Experienced Late Stent Thrombosis (Academic Research Consortium (ARC) Definition)
timeFrame: 31-360 days post-procedure
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Lowell Satler, MD
role: PRINCIPAL_INVESTIGATOR
References: