Coronary Artery DiseaseELITENCT00715884
Study Comparing the CYPHER® ELITE™ to the CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems
A study testing CYPHER® ELITE™ Sirolimus-Eluting Stent System and CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System in people with Coronary Artery Disease and Coronary Atherosclerosis, run by Cordis US Corp. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Atherosclerosis
- What is being tested?
- CYPHER® ELITE™ Sirolimus-Eluting Stent System and CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 678 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease, Coronary Atherosclerosis
- Being tested
- CYPHER® ELITE™ Sirolimus-Eluting Stent System, CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
- Keywords
- Atherosclerosis, de novo native coronary lesion
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYPHER® ELITE™ Sirolimus-Eluting Stent SystemDevice
Also called Cypher ELITE
Drug eluting stent
CYPHER® Bx VELOCITY® Sirolimus-eluting Stent SystemDevice
Also called CYPHER Bx VELOCITY
Drug eluting stent
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CYPHER® ELITE™ Sirolimus-Eluting Stent System. Receives: Device: CYPHER® ELITE™ Sirolimus-Eluting Stent System |
| 2 | Active comparator | CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System Receives: Device: CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-months post-procedure
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months post procedure
Percentage of Participants Who Experienced Target Vessel Failure (TVF)
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.
Measured: 12 months post procedure
Percentage of Participants Who Experienced Major Adverse Cardiac Events (MACE)
MAJOR ADVERSE CARDIAC EVENTS (MACE) consists of death, myocardial infarction, emergent bypass surgery, and target lesion revascularization.
Measured: 12 months post procedure
Percentage of Participants Who Had Lesions of More Than 1 Vessel and Experienced Target Lesion Failure (TLF)
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.
Measured: 12 months post procedure
Percentage of Participants Who Had Diabetes and Experienced Target Lesion Failure (TLF)
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.
Measured: 12 months post procedure
Percentage of Participants Who Experienced Bleeding Complications
Bleeding complications include any bleeding events defined by THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI), Global Strategies for Opening Occluded Coronary Arteries (GUSTO), and "Protocol" definitions.
Measured: 12 months post procedure
Percentage of Participants Who Died
Death incidences include both Cardiac and non-cardiac death.
Measured: 12 months post procedure
Percentage of Participants Who Experienced Any Myocardial Infarction (MI)
Myocardial Infarction includes both Q-wave and WHO Non-Q Wave Myocardial Infarction events.
Measured: 12 months post procedure
Percentage of Participants Who Experienced Stroke
The stroke definition includes both hemorrhagic and non-hemorrhagic strokes.
Measured: 12 months post procedure
Percentage of Participants Who Experienced Stent Thrombosis (Protocol Definition)
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.
Measured: 12 months post procedure
Percentage of Participants Who Experienced Stent Thrombosis (Academic Research Consortium (ARC) Definition)
Academic Research Consortium (ARC) defines STENT THROMBOSIS as consisting of the following:
- DEFINITE - Angiographic or pathologic confirmation;
- PROBABLE - Any unexplained death within the first 30 days or Any MI (related to documented acute ischemia and without another obvious cause) in the territory of the stent;
- POSSIBLE - Any unexplained death > 30 days.
ARC Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points.
Measured: 12 months post procedure
Percentage of Participants Who Experienced Early Stent Thrombosis (Academic Research Consortium (ARC) Definition)
Those ARC stent thromboses occurred between 0 and 30 days post-procedure are early stent thrombosis.
Measured: 0-30 days post-procedure
Percentage of Participants Who Experienced Late Stent Thrombosis (Academic Research Consortium (ARC) Definition)
Those ARC stent thromboses occurred between 31 to 360 days post-procedure are late stent thrombosis.
Measured: 31-360 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2010
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 678 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lowell Satler, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715884
- Sponsor's protocol ID
- P07-6330
- Acronym
- ELITE
- Status last verified
- Dec 2013
- First submitted
- 11 Jul 2008
- Last updated
- 20 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Blind, Randomized, Multi-Center Study Comparing the CYPHER® ELITE™ to the CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems (ELITE).
- ClinicalTrials.gov ID
- NCT00715884
- Acronym / sponsor ID
- ELITE / P07-6330
- Conditions
- Coronary Artery Disease, Coronary Atherosclerosis
- Keywords
- Atherosclerosis, de novo native coronary lesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 678 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Sep 2014 (estimated)
- First posted
- 15 Jul 2008 (estimated)
- Results
- Posted 6 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: CYPHER® ELITE™ Sirolimus-Eluting Stent SystemCYPHER® ELITE™ Sirolimus-Eluting Stent System. |
| 2 | Active comparator | Device: CYPHER® Bx VELOCITY® Sirolimus-eluting Stent SystemCYPHER® Bx VELOCITY® Sirolimus-eluting Stent System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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);
Key exclusion criteria (24 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYPHER® ELITE™ Sirolimus-Eluting Stent SystemAlso: Cypher ELITEDrug eluting stent | Device | 1 |
| CYPHER® Bx VELOCITY® Sirolimus-eluting Stent SystemAlso: CYPHER Bx VELOCITYDrug eluting stent | Device | 2 |
Primary outcome
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.
18 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lowell Satler, MD principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CYPHER® ELITE™ Sirolimus-Eluting Stent System and CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System in people with Coronary Artery Disease and Coronary Atherosclerosis, run by Cordis US Corp. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Experienced Target Lesion Failure (TLF) (time frame: 12-months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2014.