Overview

This trial is active, not recruiting.

Conditions coronary artery disease, coronary atherosclerosis
Treatments cypher® elite™ sirolimus-eluting stent system, cypher® bx velocity® sirolimus-eluting stent system
Sponsor Cordis Corporation
Start date July 2008
End date March 2010
Trial size 678 participants
Trial identifier NCT00715884, P07-6330

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
CYPHER® ELITE™ Sirolimus-Eluting Stent System.
cypher® elite™ sirolimus-eluting stent system Cypher ELITE
Drug eluting stent
(Active Comparator)
CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
cypher® bx velocity® sirolimus-eluting stent system CYPHER Bx VELOCITY
Drug eluting stent

Primary Outcomes

Measure
Percentage of Participants Who Experienced Target Lesion Failure (TLF)
time frame: 12-months post-procedure

Secondary Outcomes

Measure
Percentage of Lesion Success
time frame: At procedure
Percentage of Device Success - Protocol Definition
time frame: At procedure
Percentage of Device Success - All CYPHER® Stents Included
time frame: At procedure
Percentage of Participants Who Achieved Procedure Success
time frame: At procedure during hospital stay
Percentage of Participants Who Experienced Target Lesion Revascularization (TLR)
time frame: 12 months post-procedure
Percentage of Participants Who Experienced Target Vessel Revascularization (TVR)
time frame: 12 months post procedure
Percentage of Participants Who Experienced Target Vessel Failure (TVF)
time frame: 12 months post procedure
Percentage of Participants Who Experienced Major Adverse Cardiac Events (MACE)
time frame: 12 months post procedure
Percentage of Participants Who Had Lesions of More Than 1 Vessel and Experienced Target Lesion Failure (TLF)
time frame: 12 months post procedure
Percentage of Participants Who Had Diabetes and Experienced Target Lesion Failure (TLF)
time frame: 12 months post procedure
Percentage of Participants Who Experienced Bleeding Complications
time frame: 12 months post procedure
Percentage of Participants Who Died
time frame: 12 months post procedure
Percentage of Participants Who Experienced Any Myocardial Infarction (MI)
time frame: 12 months post procedure
Percentage of Participants Who Experienced Stroke
time frame: 12 months post procedure
Percentage of Participants Who Experienced Stent Thrombosis (Protocol Definition)
time frame: 12 months post procedure
Percentage of Participants Who Experienced Stent Thrombosis (Academic Research Consortium (ARC) Definition)
time frame: 12 months post procedure
Percentage of Participants Who Experienced Early Stent Thrombosis (Academic Research Consortium (ARC) Definition)
time frame: 0-30 days post-procedure
Percentage of Participants Who Experienced Late Stent Thrombosis (Academic Research Consortium (ARC) Definition)
time frame: 31-360 days post-procedure

Eligibility Criteria

Male or female participants at least 18 years old.

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 /= 2.25mm and 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 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.

Additional Information

Official title A Prospective, Single-Blind, Randomized, Multi-Center Study Comparing the CYPHER® ELITE™ to the CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems (ELITE).
Principal investigator Lowell Satler, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Cordis Corporation.